ConvaTec EsteemBody Drainable Pouch Recall: Leak Risk Due to Manufacturing Issue
ConvaTec recalls EsteemBody Drainable Pouch REF:423643 (10-45mm) due to potential leaks from manufacturing defects. Affected units have specific UDI and lot numbers.
Lower-risk recall
Drainable large pouch may leak due to manufacturing issue.
Contact the company
What happened, in plain English
ConvaTec is recalling its EsteemBody Drainable Pouch (REF:423643, 10-45mm) because a manufacturing issue may cause leaks. This could lead to improper wound care and infection risks if the pouch leaks. Read more at govinfonow.com/recall/49977-convatec-esteembody-drainable-pouch-recall-leak-risk-due-to-manufacturing.
Source Summary by GovInfoNow · govinfonow.com/recall/49977-convatec-esteembody-drainable-pouch-recall-leak-risk-due-to-manufacturing · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1582-2026
Cite this page
“ConvaTec EsteemBody Drainable Pouch Recall: Leak Risk Due to Manufacturing Issue.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49977-convatec-esteembody-drainable-pouch-recall-leak-risk-due-to-manufacturing. Based on FDA recall #Z-1582-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1582-2026%22&limit=1).
Why it’s dangerous
The drainable pouch may leak due to a manufacturing defect in the material. Leaks could cause wound infections or improper drainage, especially if the pouch is used for medical purposes.
Who’s affected
Users of the EsteemBody Drainable Pouch for wound care are affected. Patients with open wounds or surgical sites using this product are most at risk.
How to tell if you have this one
Check for the product name 'EsteemBody Drainable Pouch', model REF:423643, and size 10-45mm. Affected units have UDI: 00768455221264 and lot numbers 5K00011 or 5K00714.
- Brand
ConvaTec- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots |
|---|---|
| Z-1582-2026 | Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm; UDI: 00768455221264 Lot: 5K00011,5K00714 |
| Z-1583-2026 | Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm; UDI: 00768455221363 Lot: 5K01728 |
| Z-1584-2026 | Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm; UDI: 00768455221400/ Lot: 5J03908 |
What to do — step by step
Check Product Details
Verify the product name, model number, and size to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1582-2026 (February 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1582-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.