Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Epi proColon Plasma Quick Kit The diagnostic test kit may produce invalid test runs which may delay test results. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereCalifornia, Michigan, North Carolina, Nebraska, New Jersey, New York, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall SKIN STAPLE REMOVER Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SUTURE REMOVAL TRAY, SET or KIT Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GENERAL PURPOSE INSTRUMENT TRAY Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MINI PLASTICS SET Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIRCUMCISION TRAY Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CATHETER SECUREMENT SYSTEM Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ST. CHRISTOPHER’S SECUREMENT SET Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SorbaView Shield Dressing Change Tray Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TUBING CHANGE KIT Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MINOR DRESSING CHANGE TRAY Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INCISION & DRAINAGE TRAY or KIT Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BLOOD DRAW KIT Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NEONATAL IV ACCESS SET Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LATEX FREE IV START SET Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PEDIATRIC IV & IV START KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IV START KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INFANT IV SECUREMENT KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NEONATAL IV START KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EXCISION TRAY Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall WOUND CARE KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall WOUND CLOSURE TRAY - FACIAL Convenience Kit containing components to assist practitioner with IV placement and securement. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the… Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy… Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy… Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Re-Entry” Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot… Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Re-Entry” Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot… Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter… Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5 The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereColorado, Illinois, New Jersey, New York and Texas
- Medical device recall Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for… The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CATHETER REPAIR KIT There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in… There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall 12F X 40CM TESIO CATHETER SET WITH “Y” ADAPTOR There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall 12F X 60CM TESIO CATHETER SET WITH “Y” ADAPTOR There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall 12F Tesio CATHETER SET (CUFF 22CM FROM TIP) There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall 12F MODIFIED Tesio CATHETER SET There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall 12F Tesio CATHETER SET (CUFF 32CM FROM TIP) There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall TWO PART ADAPTER There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall CATHETER REPAIR KIT There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in… There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2… UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system… UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Situate Gauze RF and X-Ray detectable This voluntary recall is being conducted due to the potential for failure to detect the affected Situate” gauze - RF and Xray detectable products by the… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for… The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following… Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following… Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
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.
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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