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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jun 3, 2024 Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine wit... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a po... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 23, 2023 Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecol... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 23, 2023 Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Apr 8, 2022 TMJ Arthroscopy Drape, 85''x 96'' Latex content in product was labeled incorrectly as latex free. Class II Microtek Medical 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.