FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
- Recall number
- Z-1584-2026
- Recalling firm
- ConvaTec, Inc
- Product
- Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
- Status
- Open, Classified
- Initiated
- 2026-02-16
- Posted
- 2026-03-19
- Terminated
- not on file
- Reason
- Drainable large pouch may leak due to manufacturing issue.
- Root cause
- Process control
- Action
- 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 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
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- UDI: 00768455221400/ Lot: 5J03908
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FON
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28