Lower risk Medical device recall · FDA · Published February 19, 2024

ConvaTec EsteemBody Soft Convex Pouch Recall: Filter Weld Inconsistency Risk

ConvaTec recalls specific lots of EsteemBody Soft Convex Drainable Pouches due to inconsistent filter weld strength. Affected units have product codes listed in the recall notice. Consumers should check their product codes and contact ConvaTec for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1350-2024Medical device ConvaTec ›

Lower-risk recall

Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

ConvaTec is recalling specific lots of EsteemBody Soft Convex Drainable Pouches because the filter weld strength may be inconsistent. This could lead to leaks or failure during use, especially in medical applications where proper containment is critical. Read more at govinfonow.com/recall/56143-convatec-esteembody-soft-convex-pouch-recall-filter-weld-inconsistency-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56143-convatec-esteembody-soft-convex-pouch-recall-filter-weld-inconsistency-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1350-2024

Cite this page

“ConvaTec EsteemBody Soft Convex Pouch Recall: Filter Weld Inconsistency Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56143-convatec-esteembody-soft-convex-pouch-recall-filter-weld-inconsistency-risk. Based on FDA recall #Z-1350-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1350-2024%22&limit=1).

The FDA announced on Feb. 19, 2024, that ConvaTec, Inc. is recalling specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistent filter weld strength. The agency issued recall number Z-1350-2024 for the Class II device distributed worldwide.

How to tell if you have it

Brand: ConvaTec
Product: EsteemBody Soft Convex, Drainable Pouch
Product codes (REF): 423643, 423658, 423659, 423664, 423666, 423645, 423667, 423657, 423652, 423646, 423654, 423653, 423647, 423644, 423648, 423665, 423656, 423651, 423660, 423661
Units affected: 6709

The hazard

The recall addresses inconsistency in the strength of the filter weld on specific lots of the EsteemBody Soft Convex, Drainable Pouch. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show ConvaTec, Inc. has 17 other recalls on record since Oct. 26, 2017. Other recent recalls of similar products include ConvaTec Esteem Body Soft Urostomy Pouches (July 6, 2026), ConvaTec Aquacel Ag Surgical SP Dressings (June 8, 2026), and ConvaT: EsteemBody Drainable Pouch (Feb. 16, 2026). Other recent recalls of similar products include Covidien V-Loc 180 Absorbable Wound Closure Device (June 24, 2026), Covidien V-Loc 90 Wound Closure Device (June 24, 2026), and Covidien EndoStitch Polysorb Loading Unit (April 15, 2026).

How to tell if you have this one

Check the product code (REF) on the pouch, which includes numbers like 423643, 423658, and other codes listed in the recall notice. Also look for the Lot Numbers (e.g., 3L03391) and UDI/DI numbers provided in the recall.

Brand
ConvaTec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for the product code (REF) on the pouch, such as 423643, 423658, or other codes listed in the recall notice.
Contact ConvaTec
Reach out to ConvaTec directly for confirmation of the product code and instructions on next steps.

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 Italy, 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.

Feb 19, 2024Firm started the recall
Mar 21, 2024FDA classified it Class II
Mar 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What product codes are affected?

Product codes (REF) 423643, 423658, 423659, 423664, 423666, 423645, 423667, 423657, 423652, 423646, 423654, 423653, 423647, 423644, 423648, 423665, 423656, 423651, 423660, and 423661 are affected.

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Link to this recall

<a href="https://govinfonow.com/recall/56143-convatec-esteembody-soft-convex-pouch-recall-filter-weld-inconsistency-risk">ConvaTec EsteemBody Soft Convex Pouch Recall: Filter Weld Inconsistency Risk (GovInfoNow)</a>

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-1350-2024 (February 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1350-2024 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.