ConvaTec, Inc recalls Convatec

Drainable large pouch may leak due to manufacturing issue.

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

• FDA enforcement recordOfficial FDA database entry for Z-1584-2026
• FDA device classification · FONOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ConvaTec, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.