Browse Device Recalls

203 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 203 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 203 FDA device recalls.

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DateProductReasonClassFirm
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 6, 2024 American Contract Systems Gyn Laparoscopy convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Extremity convenience kit, American Contract System... Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Cataract Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Special Procedure Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Laparoscopy Litho Std Pack convenience kit and Amer... Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Biopsy Drape Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Hand Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Spine Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Othopedic use, labeled as: a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Ophthalmic use, labeled as: ... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, anesthesia, labeled as: a) H... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, urological, labeled as: a) U... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) HEAR... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) CENT... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, ear, nose & throat, labeled as:... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Sep 1, 2023 General Pack, REF BBGP31C During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Pediatric Urology Wolson Pack, REF BPPU55A During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... 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.