Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2021 Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product... Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. ... Class II Ecolab Inc
Sep 14, 2018 Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek ... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Sep 14, 2018 Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek ... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Sep 14, 2018 Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx S... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Sep 14, 2018 Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / ... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Nov 22, 2017 ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905... The incorrect IFU was shipped with the product. Class III ECOLAB INC
Nov 22, 2017 ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906,... The incorrect IFU was shipped with the product. Class III ECOLAB INC
Nov 30, 2016 Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the... Class III Ecolab 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 Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, RE... 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.