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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.