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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.