# FDA recall Z-1584-2026

> **ConvaTec, Inc** · Class II · device recall initiated 2026-02-16.

## Product

Convatec, EsteemBody Drainable Pouch  REF:423657  10-35mm

## Reason for recall

Drainable large pouch may leak due to manufacturing issue.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.

## Key facts

- **Recall number:** Z-1584-2026
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-16
- **Report date:** 2026-03-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greensboro, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1584-2026

## Citation

> AI Analytics. FDA recall Z-1584-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-1584-2026. Source: US FDA. Licensed CC0.

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