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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,260 FDA device recalls in 2021.

Clear
DateProductReasonClassFirm
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL488... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC
Mar 19, 2021 Univation X System Tray Sysem knee implant devices as follows: Tray Number/... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL476... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC
Mar 19, 2021 Revolution CT GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimato... Class II GE Healthcare, LLC
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NO180... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL494... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NO156... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC
Mar 19, 2021 Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specif... Users may observe additional locus specific signals at 9q34. The device pack insert indicates the... Class II Cytocell Ltd.
Mar 19, 2021 Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheteriza... On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. ... Class II Cardiac Assist, Inc
Mar 19, 2021 Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTI... Siemens has become aware of a potential issue with software version VE20C. Planned procedures may... Class II Siemens Medical Solutions USA, Inc
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL470... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 VERIGENE Processor SP - Product Usage: intended for processing and identifyin... Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella sp... Class II Luminex Corporation
Mar 18, 2021 AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intende... AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideli... Class II Fresenius Medical Care Holdings, Inc.
Mar 18, 2021 Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted in... The incorrect dental pins were packaged and subsequently distributed. Class II Coltene Whaledent Inc
Mar 18, 2021 Gentueri Viral Transport Medium (VTM), Sterile, IVD Medium showed visual turbidity and discoloration, potentially contaminating samples transported f... Class II Gentueri Inc
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 17, 2021 Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: ... Positive Control may run high out of its assigned ISR range and result in an invalid run and nece... Class II Clark Laboratories, Inc.
Mar 17, 2021 Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1... Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Ma... Class II SIGHT DIAGNOSTICS LTD
Mar 17, 2021 CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Cathe... Incorrect labeling, Catheter did not have the required holes and markings Class II Integra LifeSciences Corp.
Mar 17, 2021 BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of path... Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp... Class II Becton Dickinson & Co.
Mar 17, 2021 BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of ... Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp... Class II Becton Dickinson & Co.
Mar 17, 2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... The shelf box identifies a small device actually contains a large device, and the shelf box ident... Class II Medtronic Sofamor Danek USA, Inc
Mar 17, 2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... The shelf box identifies a small device actually contains a large device, and the shelf box ident... Class II Medtronic Sofamor Danek USA, Inc
Mar 17, 2021 Change Healthcare Enterprise Viewer Change Healthcare has identified an intermittent software defect which may result in an anchor st... Class II CHANGE HEALTHCARE CANADA COMPANY
Mar 16, 2021 Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608... Incorrect size printed on the device; packaging is labeled correctly. Class II Medtronic Inc.
Mar 16, 2021 ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Pr... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF Spinning Spiros Closed Male Luer - Product Usage: provides access for th... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, A... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 FREESTYLE LANCETS 28G 100CT Item Number:2975670 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides acce... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: prov... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 BD UF PEN 32GX4MM 100 NANO Item Number: 4292272 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filt... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" -... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLoc... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Ve... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Sp... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Dri... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PO... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.