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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Dec 23, 2019 MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order #... Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... Class II Carroll-Baccari, Inc.
Dec 23, 2019 PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... Class II Carroll-Baccari, Inc.
Dec 23, 2019 Wave Prep Tubes (1710-03) and single use cups (17--00-24) Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... Class II Carroll-Baccari, Inc.
Dec 23, 2019 LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... Class II Carroll-Baccari, Inc.
Sep 5, 2019 Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin prep... Product has the potential to be contaminated with Burholderia cepacia. Class II Carroll-Baccari, Inc.
Sep 5, 2019 Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin pr... Product has the potential to be contaminated with Burholderia cepacia. Class II Carroll-Baccari, 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.