ConvaTec Active Life Pouch Recall: Impaired Release Liner Functionality

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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 One-Piece Drainable Pouches (REF 400599) because the release liner may not function properly. This could lead to improper stoma output management, potentially causing discomfort or complications for users.

Why it’s dangerous

The release liner in the pouch may not function correctly, which could cause improper stoma output management. This might lead to discomfort or complications for users who rely on the pouch for their stoma care.

Who’s affected

People who use ConvaTec Active Life Pouches for stoma output management after colostomy or ileostomy surgery are affected. Those with specific batch numbers 2A03486 or 2B00301 are most at risk.

How to tell if you have this one

Check for the product name 'ConvaTec Active Life, One-Piece Drainable Pouch' with size 3/4-2 1/2 in. and width 19-64mm. Affected units have batch numbers 2A03486 or 2B00301.

Brand
ConvaTec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the batch number on the pouch to determine if it is affected (2A03486 or 2B00301).

✎ GovInfoNow

Questions people ask

What is the specific batch number for this recall?

The affected batch numbers are 2A03486 and 2B00301.

Is there a remedy for this recall?

The recall record does not specify a remedy.

How can I tell if my pouch is affected?

Check for the batch numbers 2A03486 or 2B00301 on the pouch.

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-0130-2023 — ConvaTec ConvaTec

Hello,

I own a ConvaTec that is covered by recall Z-0130-2023 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.

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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-0130-2023 (August 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0130-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output

Lower-risk recall