Smiths Medical ASD Inc.: Medical Device Recall in 2023 - (Recall #: Z-0205-2024)

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:

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Product Classification:

Class II

Date Initiated: August 22, 2023

Date Posted: November 8, 2023

Recall Number: Z-0205-2024

Event ID: 92996

Reason for Recall:

The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

Status: Ongoing

Product Quantity: N/A

Code Information:

Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

Distribution Pattern:

Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated