FDA Medical devices recall ·
Convatec, EsteemBody Drainable Pouch recall
- Recall number
- Z-1584-2026
- Date
- (initiated February 16, 2026)
- Company / brand
- ConvaTec, Inc
7815 National Service Rd Ste 600, Greensboro, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Why was it recalled?
Drainable large pouch may leak due to manufacturing issue.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 00768455221400/ Lot: 5J03908
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1584-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.