FDA recall record · openFDA

ConvaTec, Inc

8 FDA recalls on record (2024–2026) — 8 device. 8 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Drainable large pouch may leak due to manufacturing issue. 3

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. 1

The product does not meet sterility assurance level. 1

Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, 1

Wound dressing may have foreign matter on the product. 1

Recalls

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm Class II 2026-02-16 Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm Class II 2026-02-16 Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm Class II 2026-02-16 DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud Class II 2025-08-29 ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. Class II 2024-01-17 ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/i Class II 2024-02-27 Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 4 Class II 2024-02-19 Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh Class II 2024-11-29

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

Machine-readable: JSON-LD · Markdown