ConvaTec recalls
12 official recalls and safety alerts involving ConvaTec since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with ConvaTec or the relevant agency.
- 2026-08-26
USConvaTec, Inc recalls Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713,…
Urostomy Pouches may leak from cap during use.
FDA · DeviceConvaTec, IncUS Nationwide distribution including in the states of AR, AZ, CA, CO, DC, DE,…Official notice →- 2026-07-15
- US
ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Surgical dressing manufactured out of specification (greater thickness).
FDA · DeviceConvaTec, IncUS Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX,…Official notice → - 2026-03-25
- US
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2025-10-22
- US
ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds.…
Wound dressing may have foreign matter on the product.
FDA · DeviceConvaTec, IncUS Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL,…Official notice → - 2025-01-22
- US
ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier…
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is…
- 2024-04-17
- US
ConvaTec, Inc recalls ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5…
The product does not meet sterility assurance level.
FDA · DeviceConvaTec, IncUS Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.Official notice → - 2024-03-27
- US
ConvaTec, Inc recalls Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645,…
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Italy, UK.Official notice → - 2024-03-13
- US
ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
FDA · DeviceConvaTec, IncDistribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX.…Official notice → - 2022-12-28
- US
ConvaTec, Inc recalls 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) due to the identification of visual contamination in the form of brown spots present on several dressings.
- 2022-11-02
- US
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 following a…
impaired functionality of the release liner
- 2022-06-01
- US
ConvaTec, Inc recalls SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
FDA · DeviceConvaTec, IncDistributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL,…Official notice → - 2021-10-06
- US
ConvaTec, Inc recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Primary packaging labeling may be incorrect.
FDA · DeviceConvaTec, IncDistribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC.…Official notice →