Z-1582-2026Class II

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

Name: Z-1582-2026 Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Creator: ConvaTec, Inc
Published: 2026-02-16
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2026-02-16 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm on 2026-02-16. FDA classified it as Class II and gives the reason as "Drainable large pouch may leak due to manufacturing issue". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1582-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-16
Posted: 2026-03-19
Recalling firm: ConvaTec Limited
Product: Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Product code: FON Bag, Drainage, With Adhesive, Ostomy
Reason for recall: Drainable large pouch may leak due to manufacturing issue.
Root cause tag: manufacturing process
FDA 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 [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
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 codes and lots: UDI: 00768455221264 Lot: 5K00011,5K00714

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1582-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1582-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-19
Z-1583-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-19
Z-1584-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-19

Product code FON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)