FDAClass IIMarch 25, 2026

Convatec recall

Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm

Why was Convatec recalled?

Drainable large pouch may leak due to manufacturing issue.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 00768455221400/ Lot: 5J03908

Product
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Recalling firm
ConvaTec, Inc
Quantity
N/A
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.
Recall date
March 25, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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