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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
May 8, 2019 Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Prod... This product has been contaminated with Stenotrophomonas lactiubi. Class II Madison Polymeric Engineering
May 8, 2019 First Step Draco Pad, Product Number EP-4D This product has been contaminated with Stenotrophomonas lactiubi. Class II Madison Polymeric Engineering
Dec 14, 2018 Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: ... The product is contaminated with Pseudomonas. Class II Madison Polymeric Engineering
Mar 21, 2018 Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic D... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endo... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Cle... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Cle... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flex... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Cle... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Nov 3, 2017 First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-c... Affected lots may have exceeded its microbial limits. Class II Madison Polymeric Engineering
Apr 17, 2017 Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number:... Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. Class II Madison Polymeric Engineering

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.