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
The list
- Medical device recall ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR 2.3 W Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bien-Air Surgery The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Michigan and Minnesota named
- Medical device recall Bien-Air Surgery The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Michigan and Minnesota named
- Medical device recall Bien-Air Surgery The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Michigan and Minnesota named
- Medical device recall Stryker Instruments The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Michigan and Minnesota named
- Medical device recall Entellus Medical The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Michigan and Minnesota named
- Medical device recall Opticross 35 15 MHz Peripheral Imaging Catheter 8F Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Georgia, Maryland, Michigan, New York and South Dakota named
- Medical device recall NanoClave Connector 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” (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 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 6” (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 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 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR 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 7” (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, 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 10” (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4… 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 9” (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron… 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 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;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 5” (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit… 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 9.5” (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave,… 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
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
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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