Class IIReported 2026-03-25

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

Recalled by ConvaTec, Inc

Reason for Recall

Drainable large pouch may leak due to manufacturing issue.

Recall Number

Z-1582-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-02-16

Reported

2026-03-25

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.

Code Info

UDI: 00768455221264 Lot: 5K00011,5K00714

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.