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.

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DateProductReasonClassFirm
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.