Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Medtronic Wireless Recharger The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic… If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Nexiva, 20 GA 1.00 IN There is a breach in the product packaging that renders the product non-sterile. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, Utah, Virginia and Washington named
- Medical device recall The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of… There is a potential for distal tip dislodgement or separation. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Louisiana, Ohio, Oklahoma and Texas
- Medical device recall SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation… There is a potential for distal tip dislodgement or separation. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Louisiana, Ohio, Oklahoma and Texas
- Medical device recall SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation… There is a potential for distal tip dislodgement or separation. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Louisiana, Ohio, Oklahoma and Texas
- Medical device recall SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of… There is a potential for distal tip dislodgement or separation. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Louisiana, Ohio, Oklahoma and Texas
- Medical device recall SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation… There is a potential for distal tip dislodgement or separation. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Louisiana, Ohio, Oklahoma and Texas
- Medical device recall SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation… There is a potential for distal tip dislodgement or separation. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Louisiana, Ohio, Oklahoma and Texas
- Medical device recall Transseptal Needle, Trocar Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transseptal Needle with Catheter Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Sensis/ Sensis Vibe systems with software VD1X as follows System operator manual states that the system should be rebooted once, every 7 days. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver… Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as… Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall BIO-RAD BioPlex 2200 Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, 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, Washington, Wisconsin and West Virginia named
- Medical device recall BIO-RAD BioPlex 2200 Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, 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, Washington, Wisconsin and West Virginia named
- Medical device recall OMNI K2 Hip Stem, Manufacturer’s The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereColorado and Virginia
- Medical device recall API 50 CH, Model 50300 There is potential to provide an incorrect organism identification. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNew York, South Dakota and Wisconsin
- Medical device recall Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine… There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereColorado, Michigan and New York
- Medical device recall Ilizarov Wire Tensioner Medicalplastic s.r.l. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportTennesseethe one state its words name PublishedNov 24, 2021ClassClass IIStatusOngoingWhereTennessee
- Medical device recall VITROS Immunodiagnostic Products Anti-HBc IgM Controls Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained… Class IIIFDA’s classNov 24, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 24, 2021ClassClass IIIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Missouri, New Jersey, New York, Oklahoma, South Carolina, South Dakota, Texas, Utah, Washington, Wisconsin and West Virginia
- Medical device recall Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human… Due to a component in kit being labeled with the incorrect Expiration Date Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, Delaware, Florida, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human… Due to a component in kit being labeled with the incorrect Expiration Date Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, Delaware, Florida, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall REGARD Basic Cataract tray Povidone-Iodine swabstick manufactured by PDI, Inc. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana and Missouri named
- Medical device recall REGARD Core Biopsy Tray Povidone-Iodine swabstick manufactured by PDI, Inc. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana and Missouri named
- Medical device recall REGARD Ear Tray Povidone-Iodine swabstick manufactured by PDI, Inc. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana and Missouri named
- Medical device recall REGARD Newborn Tray Povidone-Iodine swabstick manufactured by PDI, Inc. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana and Missouri named
- Medical device recall REGARD Stereotactic Tray Povidone-Iodine swabstick manufactured by PDI, Inc. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana and Missouri named
- Medical device recall REGARD Ultrasound Tray Povidone-Iodine swabstick manufactured by PDI, Inc. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana and Missouri named
- Medical device recall REGARD Vitrectomy Tray Povidone-Iodine swabstick manufactured by PDI, Inc. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana and Missouri 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.
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.”
Your shortlist0 of 4
Add one more to compare.