# FDA recall Z-1483-2026

> **B Braun Medical Inc** · Class II · device recall initiated 2026-02-02.

## Product

Brand Name: B. Braun  Product Name: 21GA WINGED INF SET  Model/Catalog Number: 7M2802  Software Version: N/A  Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids.  Component: N/A

## Reason for recall

The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

## Distribution

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

## Key facts

- **Recall number:** Z-1483-2026
- **Recalling firm:** B Braun Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-02
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bethlehem, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2026

## Citation

> AI Analytics. FDA recall Z-1483-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1483-2026. Source: US FDA. Licensed CC0.

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