Covidien: Medical Device Recall in 2023 - (Recall #: Z-1318-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 10, 2023

Date Posted: April 5, 2023

Recall Number: Z-1318-2023

Event ID: 91841

Reason for Recall:

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

Status: Ongoing

Product Quantity: 12,310 devices

Code Information:

Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated