Summary
The FDA issued a Class II for Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm by ConvaTec, Inc. Reason: Drainable large pouch may leak due to manufacturing issue..
Details
Source
Device Recall
External ID
Z-1582-2026
Action Date
2026-03-25
Status
Ongoing
Category
device
Product Description
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Lot/Code Info: UDI: 00768455221264 Lot: 5K00011,5K00714
Quantity Affected: N/A
Reason for Recall
Drainable large pouch may leak due to manufacturing issue.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-16
Company
Greensboro, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ConvaTec, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ConvaTec, Inc have FDA actions?
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1582-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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