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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

Consumer Safety

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

1,092 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,092 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 1,092 FDA device recalls in OH.

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DateProductReasonClassFirm
May 15, 2024 ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 HAND PACK-Procedure Kit Catalog Number: WEHD16B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 14, 2024 AMT Initial Placement Dilator Set. Used to place gastrostomy devices. Devices were labelled with the incorrect guidewire labelling. Class II Applied Medical Technology Inc
May 8, 2024 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Retur... Reports of patient burns. Class I Megadyne Medical Products, Inc.
Feb 27, 2024 O.T.D - Optimum Traction Device - Street Orange. Single use traction splint. Failure of adhesive to secure the pole insert. Class II Emergency Products & Research
Feb 12, 2024 Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intub... Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... Class II Sarnova HC, Llc
Feb 12, 2024 Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal int... Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... Class II Sarnova HC, Llc
Jan 22, 2024 Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component... Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to pre... Class II Invacare Corporation
Jan 2, 2024 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1... Class II Zimmer Surgical Inc
Dec 12, 2023 Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... Class II Steris Corporation
Dec 12, 2023 Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... Class II Steris Corporation
Dec 11, 2023 ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON... There is the potential for incomplete staple line formation during the firing sequence, without m... Class II Ethicon Endo-Surgery Inc
Dec 8, 2023 Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reu... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Dec 8, 2023 Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Dec 8, 2023 Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Dec 8, 2023 Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Elec... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Nov 28, 2023 Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... Class II AtriCure, Inc.
Nov 28, 2023 Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... Class II AtriCure, Inc.
Nov 16, 2023 V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoc... Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. Th... Class II Steris Corporation
Nov 13, 2023 Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pa... Identification label on affected hookups could become illegible over time due to the label's ink ... Class II Steris Corporation
Nov 10, 2023 Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 Medex LOGICAL CATH LAB KIT, List Number M20754 There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 6IN PRESSURE TUBING, List Number MX20617 There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 6, 2023 Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides he... It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi... Class II Sarnova HC, Llc
Nov 6, 2023 Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Ite... It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi... Class II Sarnova HC, Llc
Oct 19, 2023 Para-Pak Clean Vial-For the collection, transportation, preservation, and exa... Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ... Class II Meridian Bioscience Inc
Oct 19, 2023 Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, pres... Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ... Class II Meridian Bioscience Inc
Oct 19, 2023 Cardinal Health Clean Stool Transportation System-For the collection, transpo... Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. Class II Meridian Bioscience Inc
Sep 5, 2023 Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the d... Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at... Class II Zimmer Surgical Inc
Jun 15, 2023 Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Cat... Packaging and labeling discrepancy involving product size identification and associated Unique De... Class II 3B Medical, Inc.
Jun 15, 2023 DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also ser... Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the dev... Class II Invacare Corporation
Jun 15, 2023 MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handsw... An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece.... Class II Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during elect... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
May 16, 2023 Aeris Balloon Dilation Catheter Devices were mislabeled. Class II Bryan Medical Inc
Apr 10, 2023 Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 In the remote occurrence in which the electrical contactor component present in the drying chambe... Class II Steris Corporation

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.