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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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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

302 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 302 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 302 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 7, 2021 Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Heal... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Sep 25, 2020 Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". ... Potential for the needle to detach from the cartridge after the bottom of the cartridge is twiste... Class II Cardinal Health 200, LLC
Sep 22, 2020 Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product U... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health 200, LLC
Sep 22, 2020 Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product ... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health 200, LLC
Jul 30, 2020 KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intrana... Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treat... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jun 4, 2020 Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - ... Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne... Class II Cardinal Health 200, LLC
Jun 4, 2020 Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usa... Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne... Class II Cardinal Health 200, LLC
Jan 31, 2020 Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not... Class II Cardinal Health 200, LLC
Jan 31, 2020 Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... The kits contained recalled surgical gowns. The gowns were manufactured at locations that did no... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for d... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usa... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 1... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usag... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer Private Label Item Code: 3069 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle Item code: 8881200029 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 888120... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus ... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usa... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC

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.