Convatec recall (ConvaTec, Inc)
Medical deviceClass IIOngoing
Summary: ConvaTec, Inc is recalling Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm. Reason: Drainable large pouch may leak due to manufacturing issue.
What is being recalled
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Why
Drainable large pouch may leak due to manufacturing issue.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
UDI: 00768455221363 Lot: 5K01728
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1583-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 16, 2026 |
| Reported | March 25, 2026 |
| Company | ConvaTec, Inc |
| Company location | Greensboro, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
More recalls from ConvaTec, Inc · all medical device recalls · recalls from February 2026