ConvaTec EsteemBody Drainable Pouch Recall: Leak Risk Due to Manufacturing Issue

Take action

Contact the company & request your remedy

Recalling firmConvaTec, Inc7815 National Service Rd Ste 600, N/A · Greensboro, NC 27409-9403

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

Is this product dangerous if it leaks?

Yes, leaks could lead to improper wound care and infection risks, but the hazard is low risk as the leak is due to a manufacturing issue.

How do I know if my pouch is affected?

Check for the product name 'EsteemBody Drainable Pouch', model REF:423643, size 10-45mm, UDI: 00768455221264, and lot numbers 5K00011 or 5K00714.

What should I do if I have this product?

The recall does not specify a remedy, so check the product details to confirm if it's affected and contact ConvaTec for further guidance.

Take action

Contact ConvaTec

We’ve drafted a message you can send ConvaTec to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1582-2026 — ConvaTec ConvaTec

Hello,

I own a ConvaTec that is covered by recall Z-1582-2026 from ConvaTec.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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.

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

Lower-risk recall