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. Source coverage and dates.

Records and reported status

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...

Urostomy Pouches may leak from cap during use.

Class IIReported 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...
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...

Wound dressing may have foreign matter on the product.

Class IIReported 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...
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 ...

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 IIReported 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...
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...

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 IIReported 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...
FDA device enforcement

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 IIReported 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, ...
FDA device enforcement

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 IIReported 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...

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.

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What if the search finds no matching record?

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Where can I find older records?

Use monthly 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.

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