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Browse Device Recalls

90 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 90 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 90 FDA device recalls.

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DateProductReasonClassFirm
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.
Sep 1, 2023 Breast Plastics Pack, REF BBPL20D During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Sub Q Recorder Pack, REF BPRC87A During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Robotics Pack, REF SSRO22D During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Cath Cardiac Pack, REF IHCC03V 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 Heart SJH, REF SJPH34K During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 CVS PCSU SJH, REF SJCV48J During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Vasc. Open CVOR SJH, REF SJVO56B During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Robotics Pack, REF SJVO56B During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Robotics Pack SAH, REF SAR530M During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 LAVH, REF BBLV21C During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Apr 17, 2023 Total Knee Pack, REF CETJ130, medical convenience kits Incorrect expiration date on product. Class III American Contract Systems, Inc.
Oct 12, 2022 BASIN SET, MEBS42K, general surgical kit Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the... Class II American Contract Systems, Inc.
Aug 12, 2022 COVID Test Kit Nonsterile Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 dev... Class II American Contract Systems, Inc.
Jun 16, 2022 Various PICC Line, Central Line Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Laparoscopy Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various hysterectomy, vaginal packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Cysto Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Angiography/Cath Lab packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various ENT Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Pacemaker Packs, Cardio Thoracic Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various neurology packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various eye packs, cataract packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various ob/gyn packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Port Insertion Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 D&C pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various C-section packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Breast Abdominoplasty Pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Angiography packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
May 2, 2022 Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID ... Affected products were assembled off-site by individuals who may not have been properly trained. Class I American Contract Systems, Inc.
May 2, 2022 Clean Catch Urine Kit NS 178489, AHMU58A Affected products were assembled off-site by individuals who may not have been properly trained. Class I American Contract Systems, Inc.
Mar 22, 2022 ACS IR - Angio Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 ACS Lap Chole Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 ACS Cath Lab Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Nov 21, 2018 Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits ... Potential that product has not reached complete sterilization, Class II American Contract Systems, Inc.
Dec 28, 2016 Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered ... Powdered Surgical Gloves are an FDA banned substance. 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.