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
Apr 13, 2025 Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit R... Due to non-sterile products being labeled as sterile Class II Microtek Medical, Inc.
Jul 14, 2016 Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Mi... Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile pac... Class II Ecolab Inc
Aug 18, 2015 Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-10... The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the ... Class II Ecolab Inc
Jul 2, 2013 MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoS... Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... Class II Ecolab Inc
Jul 2, 2013 MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R),... Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... Class II Ecolab Inc
Jul 2, 2013 MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R... Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... Class II Ecolab Inc
Jul 2, 2013 MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 1... Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... Class II Ecolab Inc
Jul 2, 2013 MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSil... Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... Class II Ecolab 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.