Convatec, Inc.
Convatec, Inc. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2023, with 54 FDA device recalls on record.
Top product codes for Convatec, Inc.
FDA recalls by Convatec, Inc.
10 most recent of 54- Z-2986-2026 — Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
- Z-2677-2026 — Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- Z-1582-2026 — Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
- Z-1583-2026 — Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
- Z-1584-2026 — Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
- Z-0160-2026 — 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 subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.
- Z-0903-2025 — 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), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
- Z-1495-2024 — 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.
- Z-1350-2024 — 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) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661
- Z-1276-2024 — ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Convatec, Inc.
- K230400 — Cure Catheter Closed System; Cure Dextra Closed System
- K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
- K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
- K121275 — AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
- K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
- K111365 — VITALA CONTINENCE CONTROL DEVICE
- K102536 — VITALA CONTINENCE CONTROL DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.