--- title: "ConvaTec, Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search ConvaTec, Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/convatec-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # ConvaTec, Inc recall records **15** reported ongoing 16 records in this archive. Latest source date Jul 6, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 6, 2026 FDA device enforcement ### [Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423...](https://isitonrecall.com/recall/fda-device-z-2986-2026-esteem-body-soft-convex-urostomy-pouch-model-catalog-numbers-423703-423704-423705-423707-423708-4237/) Urostomy Pouches may leak from cap during use. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA. [Official source for Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2986-2026%22) Jun 8, 2026 FDA device enforcement ### [Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R](https://isitonrecall.com/recall/fda-device-z-2677-2026-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). Class II Reported ongoing Distribution: US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO. [Official source for Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2677-2026%22) Feb 16, 2026 FDA device enforcement ### [Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm](https://isitonrecall.com/recall/fda-device-z-1582-2026-convatec-esteembody-drainable-pouch-ref-423643-10-45mm/) Drainable large pouch may leak due to manufacturing issue. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Pola... [Official source for Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1582-2026%22) Feb 16, 2026 FDA device enforcement ### [Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm](https://isitonrecall.com/recall/fda-device-z-1583-2026-convatec-esteembody-drainable-pouch-ref-423653-10-35mm/) Drainable large pouch may leak due to manufacturing issue. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Pola... [Official source for Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1583-2026%22) Feb 16, 2026 FDA device enforcement ### [Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm](https://isitonrecall.com/recall/fda-device-z-1584-2026-convatec-esteembody-drainable-pouch-ref-423657-10-35mm/) Drainable large pouch may leak due to manufacturing issue. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Pola... [Official source for Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1584-2026%22) Aug 29, 2025 FDA device enforcement ### [DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particula...](https://isitonrecall.com/recall/fda-device-z-0160-2026-duoderm-extra-thin-dressings-are-highly-flexible-control-gel-formula-dressings-designed-for-use-on-d/) Wound dressing may have foreign matter on the product. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OK, OR, PA,... [Official source for DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0160-2026%22) Nov 29, 2024 FDA device enforcement ### [Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX ...](https://isitonrecall.com/recall/fda-device-z-0903-2025-esteem-synergy-stomahesive-skin-barrier-part-of-esteem-synergy-which-is-a-two-piece-ostomy-system-co/) 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 too small and the device user tries to a... Class II Reported ongoing Distribution: US distribution to states of: OH, NY, IL [Official source for Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy syst...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0903-2025%22) Feb 27, 2024 FDA device enforcement ### [ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.](https://isitonrecall.com/recall/fda-device-z-1495-2024-convatec-carboflex-15cm-x-20cm-6-in-x-8-in-order-no-403204-odor-control-dressing-sterile-packaged-1/) The product does not meet sterility assurance level. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA. [Official source for ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile....](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1495-2024%22) Feb 19, 2024 FDA device enforcement ### [Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 4236...](https://isitonrecall.com/recall/fda-device-z-1350-2024-convatec-esteembody-soft-convex-drainable-pouch-product-codes-ref-a-423643-b-423658-c-423659-d-42366/) 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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Italy, UK. [Official source for Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 4...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1350-2024%22) Jan 17, 2024 FDA device enforcement ### [ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.](https://isitonrecall.com/recall/fda-device-z-1276-2024-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. Class II Reported ongoing Distribution: Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Can... [Official source for ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1276-2024%22) Nov 15, 2022 FDA device enforcement ### [ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive](https://isitonrecall.com/recall/fda-device-z-0723-2023-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. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0723-2023%22) Aug 16, 2022 FDA device enforcement ### [ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.](https://isitonrecall.com/recall/fda-device-z-0127-2023-convatec-esteem-durahesive-plus-drainable-pouch-3-4-2-1-2-in-19-64mm-ref-416976-for-the-management-o/) impaired functionality of the release liner Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the ma...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0127-2023%22) Aug 16, 2022 FDA device enforcement ### [ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.](https://isitonrecall.com/recall/fda-device-z-0128-2023-convatec-esteem-durahesive-plus-drainable-pouch-3-4-2-1-4-in-19-64mm-ref-416975-for-the-management-o/) impaired functionality of the release liner Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the ma...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0128-2023%22) Aug 16, 2022 FDA device enforcement ### [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 colostomy or ileostomy procedure.](https://isitonrecall.com/recall/fda-device-z-0129-2023-convatec-active-life-one-piece-drainable-pouch-3-4-2-1-2-in-19-64mm-ref-400598-for-the-management-of/) impaired functionality of the release liner Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the mana...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0129-2023%22) Aug 16, 2022 FDA device enforcement ### [ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.](https://isitonrecall.com/recall/fda-device-z-0130-2023-convatec-active-life-one-piece-drainable-pouch-3-4-2-1-2-in-19-64mm-ref-400599-for-the-management-of/) impaired functionality of the release liner Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the mana...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0130-2023%22) Apr 22, 2022 FDA device enforcement ### [SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.](https://isitonrecall.com/recall/fda-device-z-1134-2022-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. Class II Reported terminated Distribution: Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India. [Official source for SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual waf...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1134-2022%22) ## Reasons in these listed records - Urostomy Pouches may leak from cap during use. - Surgical dressing manufactured out of specification (greater thickness). - Drainable large pouch may leak due to manufacturing issue. - Wound dressing may have foreign matter on the product. These examples come from this result page and are not a ranking of every recall reason. ## Checking ConvaTec, Inc ### Is there a recall on convatec, inc right now? This archive contains 16 records, including 15 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search ConvaTec, Inc](https://isitonrecall.com/check/?q=ConvaTec%2C%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)