Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm

FDA device recall Z-1584-2026 · posted 2026-03-19 · Open, Classified

Recall details

Recalling firm

ConvaTec, Inc

Reason for recall

Drainable large pouch may leak due to manufacturing issue.

Action taken

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

Root cause

Process control

Status

Open, Classified

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, S

Date initiated

2026-02-16

Date posted

2026-03-19

Location

Greensboro, NC