ConvaTec, Inc Recalls

8 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (8)

February 16, 2026
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Drainable large pouch may leak due to manufacturing issue.
Class II
February 16, 2026
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
Class II
February 16, 2026
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Drainable large pouch may leak due to manufacturing issue.
Class II
August 29, 2025
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 particularly suitable in areas s
Wound dressing may have foreign matter on the product.
Class II
November 29, 2024
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 WHT16/35MM PRECUT(1X10)
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 apply, this could cause abrasion, stomal cut, and bleeding
Class II
February 27, 2024
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.
The product does not meet sterility assurance level.
Class II
February 19, 2024
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) 423646, k) 423654, l) 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 II
January 17, 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

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