ConvaTec, Inc recalls
Every recall we track for ConvaTec, Inc — 26 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from ConvaTec, Inc fell by more than half in 2025 (1, down from 4 in 2024).
All FDA recall records for ConvaTec, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 2 | 0 | 2 |
| 2019 | 0 | 1 | 4 | 0 | 5 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 6 | 0 | 6 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 1 | 3 | 0 | 4 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 5 | 0 | 5 |
Most common reasons for ConvaTec, Inc recalls
What to do if you have a recalled ConvaTec, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All ConvaTec, Inc recalls
18 shown- Lower riskMedical device
ConvaTec, Inc recalls Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710,
ConvaTec recalls specific models of Esteem Body Soft Urostomy Pouches that may leak from the cap during use. Affected units include model numbers 423703-423718 and 423721-423727.
ConvaTecJul 6, 2026 - Lower riskMedical device
ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
ConvaTec recalls Aquacel Ag Surgical SP dressings (lot 5G00809) manufactured with incorrect thickness. These dressings may not provide adequate wound coverage. Consumers should contact ConvaTec for details.
ConvaTecJun 8, 2026 - Lower riskMedical device
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
ConvaTec recalls EsteemBody Drainable Pouch REF:423643 (10-45mm) due to potential leaks from manufacturing defects. Affected units have specific UDI and lot numbers.
ConvaTecFeb 16, 2026 - Lower riskMedical device
ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly
ConvaTec recalls DuoDERM Extra Thin dressings due to potential foreign matter. These flexible wound dressings may contain impurities that could affect wound healing. Consumers should check product labels for UDI-DI 768455150922 and lot 3L04808.
ConvaTecAug 29, 2025 - Use cautionMedical device
ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an
ConvaTec recalls Esteem Synergy Stomahesive Skin Barrier products with incorrect pre-cut wafer sizes (16mm or 35mm) that could cause abrasion, stomal cuts, or bleeding if used improperly.
ConvaTecNov 29, 2024 - Lower riskMedical device
ConvaTec, Inc recalls ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1
ConvaTec recalls sterile odor control dressings that don't meet sterility standards. Affected units include specific lot numbers and packaging. Consumers should check their product details to determine if recalled.
ConvaTecFeb 27, 2024 - Lower riskMedical device
ConvaTec, Inc recalls Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e)
ConvaTec recalls specific lots of EsteemBody Soft Convex Drainable Pouches due to inconsistent filter weld strength. Affected units have product codes listed in the recall notice. Consumers should check their product codes and contact ConvaTec for details.
ConvaTecFeb 19, 2024 - Lower riskMedical device
ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
ConvaTec recalls a specific ostomy kit due to a mismatched coupling ring size (45mm vs 57mm) that could cause improper fitting.
ConvaTecJan 17, 2024 - Lower riskMedical device
ConvaTec, Inc recalls ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
ConvaTec recalls AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to brown spots found on some dressings. Affected units have REF 420861, Batch 1C03858, expiring 01 Mar 2023.
ConvaTecNov 15, 2022 - Lower riskMedical device
ConvaTec, Inc recalls ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output
ConvaTec recalls Active Life One-Piece Drainable Pouches with impaired release liner functionality. This affects stoma output management after colostomy or ileostomy procedures.
ConvaTecAug 16, 2022 - Lower riskMedical device
ConvaTec, Inc recalls SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
ConvaTec recalls SUR-FIT Natura S4S 70mm wafers due to skin barrier delamination and tape tears reported in 10 complaints. Affected units have specific lot numbers and expiration dates.
ConvaTecApr 22, 2022 - Lower riskMedical device
ConvaTec, Inc recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
ConvaTec recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) due to possible incorrect primary packaging labeling. Affected items have Lot Number 8G03458 and expire July 2023.
ConvaTecAug 20, 2021 - Lower riskMedical device
ConvaTec, Inc recalls DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM
ConvaTec recalls DuoDERM CGF and Extra Thin Dressings due to potential open seals that could compromise sterility. Affected lots and models listed. Consumers should contact for details.
ConvaTecAug 9, 2021 - Use cautionMedical device
ConvaTec, Inc recalls Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2)
ConvaTec recalls Convex Two-Piece Ostomy Skin Barriers (brands: Combihesive Natura Durahesive, SurFit Natura Durahesive, Natura, Varicare) manufactured Feb 2017-Sep 2018 due to off-center starter hole causing potential stoma misalignment.
ConvaTecSep 6, 2019 - Lower riskMedical device
ConvaTec, Inc recalls Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product
ConvaTec recalls Nelaton urinary catheters with potential sterile packaging breach. These disposable catheters may risk infection if not properly sealed. Consumers should check labels for CH16/40CM or CH14/40CM models.
ConvaTecJan 9, 2019 - Lower riskMedical device
ConvaTec, Inc recalls AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301
ConvaTec recalls AbViser AutoValve IAP monitoring devices (REF ABV300/ABV301) due to potential pinhole breaches in sterile barriers. Affected units may leak fluid during use.
ConvaTecJul 3, 2018 - Lower riskMedical device
ConvaTec, Inc recalls Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with
ConvaTec recalls Esteem Synergy Stomahesive skin barrier wafers with a larger stoma hole than labeled, which may cause improper fit and discomfort for ostomy users.
ConvaTecApr 25, 2018 - Lower riskMedical device
ConvaTec, Inc recalls SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended
ConvaTec recalls 10-pack SUR-FIT Natura Moldable Durahesive Skin Barrier (REF 411802) due to incorrect labeling with a different product. Affected units were shipped in Lot 7H02242.
ConvaTecOct 26, 2017
ConvaTec, Inc recall questions
How many recalls has ConvaTec, Inc had?
26 recalls from ConvaTec, Inc are on record with U.S. safety agencies, from 2017–2026.
What is the most recent ConvaTec, Inc recall?
ConvaTec, Inc recalls Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710,, dated Jul 6, 2026. Every ConvaTec, Inc recall is listed on this page, newest first.
Why are ConvaTec, Inc products recalled?
The most common reasons on record: impaired functionality of the release liner (4); Drainable large pouch may leak due to manufacturing issue. (3).
What should I do if I have a recalled ConvaTec, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new ConvaTec, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.