- Recalling firm
- ConvaTec, Inc
- Reason for recall
- Drainable large pouch may leak due to manufacturing issue.
- Affected products (lot / model / serial)
- UDI: 00768455221363 Lot: 5K01728
- Units affected
- N/A
- Distribution pattern
- 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.
- Firm location
- Greensboro, NC, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1583-2026
- Recall initiated
- February 16, 2026
- FDA classification date
- March 19, 2026
- FDA report date
- March 25, 2026
- FDA event ID
- 98455
- Last updated on HTM Vibe
- July 24, 2026