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Recalls Medical devices 2020

Medical devices, 2020

Shortlist up to four to read them side by side.

3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.

FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.

3,055of 3,055 medical device recallsshown with your filters

By the year FDA published them20262,589 20252,908 20243,394 20232,477 20222,192 20212,30320203,05520192,801 20183,757 20172,615 20163,246 20152,495 20143,059 20132,249 20121,310

Filters

FDA’s class Class IClass IIClass III

FDA’s own classes: Class I is the most serious. Each recall’s page quotes FDA’s definition.

Status, in FDA’s file OngoingCompletedTerminated

Where it went, in FDA’s words FDA says nationwideAlabamaAlaskaAmerican SamoaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of ColumbiaFloridaGeorgiaGuamHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaNorthern Mariana IslandsOhioOklahomaOregonPennsylvaniaPuerto RicoRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUS Virgin IslandsUtahVermontVirginiaWashingtonWest VirginiaWisconsinWyoming

The states FDA’s words on where the product went name. “Nationwide” is its own choice: to FDA it means the fifty states or a significant portion, so a recall is never counted for a state its words don’t name.

The reason May fail, or give wrong resultsSterility not assuredChemicals, metals or drugs that shouldn’t be in itLabels that are wrong or missingGerms: Listeria, Salmonella, E. coli and othersPieces of metal, glass or plasticStrength, purity or how it was made

Grouped from FDA’s own reason for each recall, which every record shows in full.

Published in FDA’s report

Any

In FDA’s record Class IStill ongoing

The list

Filter by product, brand, reason or number

Order the list NewestNewest firstNameName

Medical device recallsPublishedClassStatusWhere

Medical device recall 6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case.… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case.… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 78” (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 128” (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch,… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case.… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 22” (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch,… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 112” (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock,… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 5.5” (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps,… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 124” (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 7” (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 135 cm (53”) Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall DISTALE - 203 cm Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall PROXIMALE, 28 cm Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 8” (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 7 IN(18 cm)APPX 1.2ml Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 5.5” (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches… Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall SOBEL WESTEX Disposable Isolation Gown Due to non-surgical isolation gowns not meeting all performance test requirements. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Tennessee named
Medical device recall Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an… FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named
Medical device recall Levo Arm Label: LEVO ARM Due to the potential for fluid ingress into the Arm which could affect the device’s electrical system and lead to a failure of the locking mechanism Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
Medical device recall Servo-i Ventilator A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedOct 21, 2020ClassClass IIStatusOngoingWhereArizona, California, Georgia, Illinois, Minnesota, Missouri, North Carolina, New Jersey, New York, Rhode Island, South Carolina, Texas, Virginia, Wisconsin and West Virginia
Medical device recall Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item:… Product potentially being packaged without a taper adapter or baseplate. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Minnesota, Ohio and Wyoming named
Medical device recall Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites… The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket… Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 21, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Tennessee, Virginia, Washington and Wisconsin named
Medical device recall Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health” PROTEXIS” Latex Micro Surgical Gloves -… The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning… Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and West Virginia named
Medical device recall SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product… Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Virginia, Washington and Wisconsin named

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Source:

FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”

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CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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