# FDA recall Z-1276-2024

> **ConvaTec, Inc** · Class II · device recall initiated 2024-01-17.

## Product

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

## Reason for recall

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

## Distribution

Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX.  There was government distribution but no military distribution.  Foreign distribution was made to Canada.

## Key facts

- **Recall number:** Z-1276-2024
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-17
- **Report date:** 2024-03-13

- **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-1276-2024

## Citation

> AI Analytics. FDA recall Z-1276-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1276-2024. Source: US FDA. Licensed CC0.

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