Browse Device Recalls

99 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 99 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 99 FDA device recalls.

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DateProductReasonClassFirm
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
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
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

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.