# FDA recall Z-0263-2025

> **Westmed, Inc.** · Class II · device recall initiated 2024-09-27.

## Product

1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P    2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132    The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or  mask).

## Reason for recall

Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.

## Distribution

U.S.: AK, CA, CO, DC, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA, and WV  O.U.S.: N/A

## Key facts

- **Recall number:** Z-0263-2025
- **Recalling firm:** Westmed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-27
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tucson, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0263-2025

## Citation

> AI Analytics. FDA recall Z-0263-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0263-2025. Source: US FDA. Licensed CC0.

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