Browse Device Recalls

43 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 43 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 43 FDA device recalls.

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DateProductReasonClassFirm
Feb 16, 2026 Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm Drainable large pouch may leak due to manufacturing issue. Class II ConvaTec, Inc
Feb 16, 2026 Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm Drainable large pouch may leak due to manufacturing issue. Class II ConvaTec, Inc
Feb 16, 2026 Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm Drainable large pouch may leak due to manufacturing issue. Class II ConvaTec, Inc
Aug 29, 2025 DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressi... Wound dressing may have foreign matter on the product. Class II ConvaTec, Inc
Nov 29, 2024 Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a t... Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut... Class II ConvaTec, Inc
Feb 27, 2024 ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Contro... The product does not meet sterility assurance level. Class II ConvaTec, Inc
Feb 19, 2024 Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 42... Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the E... Class II ConvaTec, Inc
Jan 17, 2024 ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 4169... The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for... Class II ConvaTec, Inc
Nov 15, 2022 ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) d... Class II ConvaTec, Inc
Aug 16, 2022 ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... impaired functionality of the release liner Class II ConvaTec, Inc
Aug 16, 2022 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, RE... impaired functionality of the release liner Class II ConvaTec, Inc
Aug 16, 2022 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, RE... impaired functionality of the release liner Class II ConvaTec, Inc
Aug 16, 2022 ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... impaired functionality of the release liner Class II ConvaTec, Inc
Apr 22, 2022 SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contai... Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, sk... Class II ConvaTec, Inc
Aug 20, 2021 DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) Primary packaging labeling may be incorrect. Class II ConvaTec, Inc
Aug 9, 2021 DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressin... There is a potential for open seals which can compromise sterility. Class II ConvaTec, Inc
Sep 6, 2019 Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following br... ConvaTec has received complaints associated with use of convex two-piece skin barriers where the ... Class II ConvaTec, Inc
Jan 9, 2019 Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usag... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: ... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled ... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jul 3, 2018 AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient ... Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the ... Class II ConvaTec, Inc
Apr 25, 2018 Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Pro... It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier ... Class II ConvaTec, Inc
Oct 26, 2017 SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Co... A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Ski... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubin... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O... Class II ConvaTec, Inc
May 10, 2017 Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Pro... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing,... Class II ConvaTec, Inc
May 10, 2017 Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM Class II ConvaTec, Inc
May 10, 2017 Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL ... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Pro... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreat... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Cod... Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use we... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, ... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreath... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreat... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FIT... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tu... Class II ConvaTec, Inc
Nov 11, 2015 Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended... The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction o... Class II ConvaTec, 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.