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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Apr 25, 2024 EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only Due to saline conductivity issues, their is a potential that dilation catheters may provide inacc... Class II Covidien, LLC
Jun 2, 2023 Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytos... Cell Collection Device may be at increased risk of the sponge detaching from the string during re... Class II Covidien, LLC
May 22, 2023 Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuratio... Class II Covidien, LLC
Nov 23, 2022 COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi... The product is labeled with the incorrect expiration date. Class II Covidien, LLC
Jun 6, 2016 Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastro... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC

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.