Convatec, Inc: Bag, Drainage, With Adhesive, Ostomy
- Recalling firm
- ConvaTec, Inc
- Product
- Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
- Reason
- Drainable large pouch may leak due to manufacturing issue.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-16
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/19b538da-7909-44b9-980f-e8bb95dbb5a9