Browse Device Recalls
1,062 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,062 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 1,062 FDA device recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 15, 2024 | ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C | 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 - 297835 -Procedure Kit Catalog Number: RGTK10L | 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 -Procedure Kit Catalog Number: QPTK95B | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG | 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 - 247546 - Procedure tray Catalog Number: BFTK01AA | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: ... | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B | 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, ST LUKES Catalog Number: LMTK17AP | 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 -Procedure Kit Catalog Number: QPTK95A | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | KNEE SCOPE Procedure tray Catalog Number: COKN48L | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F | 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 - 247546 Procedure tray Catalog Number: BFTK01Z | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G | 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: WEHD16C | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| 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 |
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.