# FDA recall Z-1318-2023

> **Covidien** · Class II · device recall initiated 2023-02-10.

## Product

COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D.    The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for  airway management by oral/nasal intubation of the trachea for anesthesia  or other short-term procedures.

## Reason for recall

Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

## Distribution

U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV  O.U.S.: Canada

## Key facts

- **Recall number:** Z-1318-2023
- **Recalling firm:** Covidien
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-10
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boulder, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2023

## Citation

> AI Analytics. FDA recall Z-1318-2023. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1318-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*