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U.S. Department of Health and Human Services

Class 2 Device Recall Convatec, EsteemBody Drainable Pouch

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 Class 2 Device Recall Convatec, EsteemBody Drainable Pouchsee related information
Date Initiated by FirmFebruary 16, 2026
Date PostedMarch 19, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1582-2026
Recall Event ID 98455
Product Classification Bag, drainage, with adhesive, ostomy - Product Code FON
ProductConvatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Code Information UDI: 00768455221264 Lot: 5K00011,5K00714
FEI Number 3011987967
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7815 National Service Rd Ste 600
Greensboro NC 27409-9403
For Additional Information Contact
336-547-3730
Manufacturer Reason
for Recall		Drainable large pouch may leak due to manufacturing issue.
FDA Determined
Cause 2		Process control
ActionOn 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 us.customerservice@convatec.com 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
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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