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 |
|---|---|---|---|---|
| Feb 6, 2025 | NEURO IR TRAY , Model No WENI56J | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | CV BASIC PUMP PACK , Model No WECV23D | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | THORACIC PACK , Model No UTTC82Y UTTC82AA-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | AV FISTULA , Model No UTAV77T | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | BORN ON ARRIVAL KIT , Model No LLBN11B | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | CYSTO PACK , Model N. HKCY31A | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | CYSTO , Model No SACY80R | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LAPAROSCOPY PACK , Model No SFLA02A SFLA02B | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | DELIVERY PACK , Model No SGDV22D-01 SGDV22E | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | DIAGNOSTIC NEURO IR TRAY , Model No WENE21 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | C-SECTION PACK, Model Nos LLCS44F LLCS44F-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LABOR & DELIVERY PACK, Model Nos LLLD19H | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01... | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 4, 2025 | CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. | During an internal investigation, ACS was unable to confirm that the CODMAN component achieved th... | Class II | American Contract Systems Inc |
| Nov 26, 2024 | AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Mode... | The extension sets subject to this recall have ENFit connections, although they should have non- ... | Class II | Applied Medical Technology Inc |
| Jun 17, 2024 | Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Prod... | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... | Class I | Megadyne Medical Products, Inc. |
| Jun 17, 2024 | Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGA... | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... | Class I | Megadyne Medical Products, Inc. |
| Jun 17, 2024 | Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product N... | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... | Class I | Megadyne Medical Products, Inc. |
| Jun 13, 2024 | Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups ... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| Jun 13, 2024 | Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups prov... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| Jun 13, 2024 | Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| Jun 13, 2024 | Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups prov... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| May 15, 2024 | KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A | 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 297829--Procedure Kit Catalog Number: RGHN04I | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA | 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 PACK-Procedure Kit Catalog Number: WEKA15B | 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: TNAR22V | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X | 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: SFTK54B | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B | 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: RGTK10K | 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: UDKN68AE | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems Inc |
| May 15, 2024 | MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B | 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 PACK Catalog Number: MEKA12R | 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: SMTK21C | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... | Class II | American Contract Systems 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.