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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
Aug 2, 2018 Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazon... The product is labeled with an incorrect expiration date. Class III Acumedia Manufacturers, Inc.
Aug 2, 2018 Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media... Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and labe... Class III Acumedia Manufacturers, Inc.
Sep 25, 2016 Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the di... Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... Class III Acumedia Manufacturers, Inc.
Aug 8, 2016 Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Produc... Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... Class III Acumedia Manufacturers, Inc.
Apr 22, 2016 Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. ... Class II Acumedia Manufacturers, Inc.
Mar 23, 2016 Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gel... Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016.... Class III Acumedia Manufacturers, Inc.
Nov 30, 2015 Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is us... Contamination of product with possible Bacillus spp Class II Acumedia Manufacturers, Inc.
Sep 11, 2015 Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder ... Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labe... Class III Acumedia Manufacturers, 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.