FDA Device Intelligence
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Bag, Drainage, With Adhesive, Ostomy

FDA product code FON · Class 1 · Gastroenterology, Urology

315
Registered devices
147
Adverse events
5
Recalls
3
510(k) clearances

Devices with this code

Eakin — T.G. EAKIN LIMITEDSUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTMedline — MEDLINE INDUSTRIES, INC.AWI — Apex (Suzhou) Medical Products CompanyEakin — T.G. EAKIN LIMITEDAWI — Apex (Suzhou) Medical Products CompanyESTEEM+ — CONVATEC, PURCHASING DEPARTMENTESTEEM+ — CONVATEC, PURCHASING DEPARTMENTJenshhch — Saibainian Medical Technology (Wuhan) Co., Ltd.NATURA — CONVATEC, PURCHASING DEPARTMENTNATURA+ — CONVATEC, PURCHASING DEPARTMENTSUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTEakin — T.G. EAKIN LIMITEDNATURA — CONVATEC, PURCHASING DEPARTMENTACTIVELIFE — CONVATEC, PURCHASING DEPARTMENTSUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTSteawoce — Wuhan Sitaili Medical Apparatus Development Co., Ltd.NATURA+ — CONVATEC, PURCHASING DEPARTMENTESTEEM+ — CONVATEC, PURCHASING DEPARTMENTESTEEM+ — CONVATEC, PURCHASING DEPARTMENTACTIVELIFE — CONVATEC, PURCHASING DEPARTMENTNATURA — CONVATEC, PURCHASING DEPARTMENTNATURA+ — CONVATEC, PURCHASING DEPARTMENTACTIVELIFE — CONVATEC, PURCHASING DEPARTMENT

Recent recalls

DateFirmReason
2026-02-16ConvaTec, IncDrainable large pouch may leak due to manufacturing issue.
2026-02-16ConvaTec, IncDrainable large pouch may leak due to manufacturing issue.
2026-02-16ConvaTec, IncDrainable large pouch may leak due to manufacturing issue.
2024-02-19ConvaTec, IncConvatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in
2024-01-17ConvaTec, IncThe kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.