ESTEEM recallZ-1582-2026 · ConvaTec, Inc · initiated Feb 16, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Drainable large pouch may leak due to manufacturing issue.
FDA root cause category: Process control
What the company is doing
On February XX, 2026 Convatec issued a updated Urgent Medical Device Recall Notification via E-Mail. The initial notification was issued February 16, 2026. Convatec asked consignees to take the following actions: 1. Review your personal supplies and determine if you are affected by this communication. 2. Discontinue use and dispose of the affected product. 3. Complete Response Form and return to Convatec within 30 days. 4. Acknowledgment of this action is critical. If you re not able to provide a written response liaise with your distributor or Convatec Customer Services can support. 5. Customer care team is available to assist you with any questions and provide product alternatives if needed. Please contact the regional Convatec Customer Services [email protected] Distributor: 1. Notify all downstream customers who may have received affected product. This letter may be used to support transmission of the communication. 2. For additional instructions reference customer notification
Recall details
- Recall number
- Z-1582-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 16, 2026
- Posted by the FDA
- Mar 19, 2026
- Recalling firm
- ConvaTec, Inc
- Product code
- FON
- 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.
Product description
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Code information (models, lots, serial numbers)
UDI: 00768455221264 Lot: 5K00011,5K00714
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ESTEEM 423643Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98455).
- Z-1583-2026 · Open, ClassifiedConvatec, EsteemBody Drainable Pouch REF:423653 10-35mm
- Z-1584-2026 · Open, ClassifiedConvatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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