# FDA recall Z-1012-2023

> **TELEFLEX LLC** · Class II · device recall initiated 2022-12-08.

## Product

Endotracheal Tube labeled as the following:    a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff;      b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff;      c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid;      d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill;      e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy.    Intended for patients requiring endotracheal intubation

## Reason for recall

Potential for pilot balloon non-inflation or cuff non-deflation.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WA, WI, WV and PR. The countries of Albania, Armenia, Austria, Azerbaijan, Bahamas, Barbados, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Croatia, Cyprus, Czech, Denmark, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy Israel, Jordan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayotte, Mexico, Moldova, Morocco, Nepal, Netherlands, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, South Africa, South Korea, Sweden, Switzerland, Taiwan Thailand, Turkey, Ukraine, United Arab Emirates.

## Key facts

- **Recall number:** Z-1012-2023
- **Recalling firm:** TELEFLEX LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-08
- **Report date:** 2023-02-01

- **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-1012-2023

## Citation

> AI Analytics. FDA recall Z-1012-2023. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1012-2023. Source: US FDA. Licensed CC0.

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