# FDA recall Z-1294-2021

> **TELEFLEX MEDICAL INC** · Class II · device recall initiated 2021-02-18.

## Product

RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

## Reason for recall

Teleflex is voluntarily recalling the products referenced above due to customers reporting that the  laryngoscope handles develop cracks and/or break at the hinge.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,  NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI.  The country of Canada.

## Key facts

- **Recall number:** Z-1294-2021
- **Recalling firm:** TELEFLEX MEDICAL INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-18
- **Report date:** 2021-03-31

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2021

## Citation

> AI Analytics. FDA recall Z-1294-2021. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-1294-2021. Source: US FDA. Licensed CC0.

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