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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 4, 2025 | Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL L... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description RCEN25B ENT SDSC 024697... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MI... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 2... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item number/ Product description AKGN82E GENERA... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description FHCP08Y C SECTION PK H... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GE... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK ... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Basic Biopsy Tray, Item Number NMBP44L | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits IHDC30R D AND C PACK | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item number/ Product description AHLD15X LABOR ... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMC... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description BFCT04X CATARACT PACK -... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Sep 4, 2025 | Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHA... | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... | Class II | American Contract Systems Inc. |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | TOTAL HIP PACK , Model No SMTH06O SMTH06P | 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. CALS41F, CALS41F-01, CALS41G | 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 Nos LLLA21J LLLA21J-02 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | EAR PACK , Model No SFEA12A | 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 | 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 |
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.