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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Convatec EsteemBody Drainable Pouches Recalled for Potential Leaks

Agency Publication Date: March 19, 2026
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Summary

ConvaTec, Inc. is recalling three versions of its EsteemBody Drainable Pouches because a manufacturing issue may cause the large pouches to leak. The recall affects several lots of the 10-35mm and 10-45mm pouches distributed worldwide, including across the United States. These pouches are used by patients with ostomies, and a leak could lead to skin irritation or soilage of clothing and bedding.

Risk

A defect in the manufacturing process can cause the pouch to leak its contents. This poses a risk of skin breakdown or infection due to contact with waste, as well as significant inconvenience and hygiene concerns for the user.

What You Should Do

  1. Check your pouch packaging for the following REF (Reference) numbers and Lot numbers: REF 423643 (Lots 5K00011, 5K00714), REF 423653 (Lot 5K01728), or REF 423657 (Lot 5J03908).
  2. Verify the UDI codes on your product labels: 00768455221264, 00768455221363, or 00768455221400.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Convatec, EsteemBody Drainable Pouch (10-45mm)
Variants: 10-45mm
Model / REF:
423643
Lot Numbers:
5K00011
5K00714
UDI:
00768455221264

Recall #: Z-1582-2026

Product: Convatec, EsteemBody Drainable Pouch (10-35mm)
Variants: 10-35mm
Model / REF:
423653
Lot Numbers:
5K01728
UDI:
00768455221363

Recall #: Z-1583-2026

Product: Convatec, EsteemBody Drainable Pouch (10-35mm)
Variants: 10-35mm
Model / REF:
423657
Lot Numbers:
5J03908
UDI:
00768455221400

Recall #: Z-1584-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98455
Status: Active
Manufacturer: ConvaTec, Inc
Sold By: Medical supply distributors
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.