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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Apr 19, 2021 Econocare Plus Waffle Overlay- Intended for use as a medical device to aid i... Product contamination-a trace amount of dried bodily fluids may expose patients, health care prov... Class II EHOB, Inc.
Jun 9, 2020 Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE O... QC inspection observed that a portion of the lot may have been contaminated with blood. Class II EHOB, Inc.
Jan 19, 2020 Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and t... Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay p... Class II EHOB, 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.