ConvaTec Active Life Pouch Recall: Impaired Release Liner Functionality
ConvaTec recalls Active Life One-Piece Drainable Pouches with impaired release liner functionality. This affects stoma output management after colostomy or ileostomy procedures.
Lower-risk recall
impaired functionality of the release liner
Contact the company
What happened, in plain English
ConvaTec is recalling One-Piece Drainable Pouches for stoma output management due to a release liner that may not function properly. This could lead to improper drainage and discomfort for users. Read more at govinfonow.com/recall/60146-convatec-active-life-pouch-recall-impaired-release-liner-functionality.
Source Summary by GovInfoNow · govinfonow.com/recall/60146-convatec-active-life-pouch-recall-impaired-release-liner-functionality · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0129-2023
Cite this page
“ConvaTec Active Life Pouch Recall: Impaired Release Liner Functionality.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60146-convatec-active-life-pouch-recall-impaired-release-liner-functionality. Based on FDA recall #Z-0129-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0129-2023%22&limit=1).
Why it’s dangerous
The release liner may not function properly, potentially causing improper drainage of stoma output. This could lead to discomfort or skin irritation but does not pose a direct injury risk.
Who’s affected
People who use ConvaTec Active Life One-Piece Drainable Pouches for stoma output after colostomy or ileostomy procedures are affected. Those with recent stoma surgeries are most at risk.
How to tell if you have this one
Check for the product name 'ConvaTec Active Life One-Piece Drainable Pouch', size 3/4-2 1/2 in., and model REF 400598. The batch numbers 2A03487 and 2B00300 are associated with this recall.
- Brand
ConvaTec- Category
Medical device
All 4 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
US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0127-2023 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.; UDI/DI: 768455115358, Batch Numbers: 2A00585, 2A00586, 2A04528, 2A04529, 2A04530m | 5284 units |
| Z-0128-2023 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.; UDI/DI: 768455115334, Batch Number: 2A02671 | 182 units |
| Z-0129-2023 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.; UDI/DI: 768455102891, Batch numbers: 2A03487, 2B00300 | 3209 units |
| Z-0130-2023 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.; UDI/DI: 768455102907, Batch numbers: 2A03486, 2B00301 | 2611 units |
What to do — step by step
Check Product Details
Verify the product name, size, and model number to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months 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.
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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-0129-2023 (August 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0129-2023 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.