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CLASS II · ModerateFDA

ConvaTec, Inc recalls Convatec

📅 Feb 16, 2026 · 📍 Nationwide
Recalling company
ConvaTec, Inc
Product
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Reason
Drainable large pouch may leak due to manufacturing issue.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Feb 16, 2026
Reported
Mar 25, 2026
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.
Status
Ongoing
Quantity
N/A
Lot / codes
UDI: 00768455221264 Lot: 5K00011,5K00714
Company location
Greensboro, NC
Recall type
Voluntary: Firm initiated
Recall number
Z-1582-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1582-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.