ConvaT: EsteemBody Drainable Pouch Leak Recall - 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:423653, 10-35mm) because a manufacturing issue may cause leaks. This could lead to improper drainage and potential complications for users.

Why it’s dangerous

The drainable pouch may leak due to a manufacturing defect. This could cause improper drainage of bodily fluids, potentially leading to infection or other complications if not managed correctly.

Who’s affected

Users of the EsteemBody Drainable Pouch with UDI: 00768455221363 and Lot: 5K01728 are affected. Patients using this product for medical drainage are most at risk.

How to tell if you have this one

Check for the product name 'EsteemBody Drainable Pouch', reference number REF:423653, and size 10-35mm. Affected units have UDI: 00768455221363 and Lot: 5K01728.

Brand
ConvaTec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, reference number, size, and unique identifier (UDI) and lot number to confirm if your unit is affected.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall states the pouch may leak due to a manufacturing issue, which could lead to improper drainage and potential complications, but it is not described as causing serious injury in normal use.

How do I know if my product is affected?

Check for the product name 'EsteemBody Drainable Pouch', reference number REF:423653, size 10-35mm, UDI: 00768455221363, and lot number 5K01728.

What should I do if I have this product?

The recall does not specify a remedy, so contact ConvaTec directly for guidance on next steps.

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-1583-2026 — ConvaTec ConvaTec

Hello,

I own a ConvaTec that is covered by recall Z-1583-2026 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-1583-2026 (February 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1583-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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:423653 10-35mm

Lower-risk recall