Covidien: Medical Device Recall in 2025 - (Recall #: Z-1390-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

Product Classification:

Class I

Date Initiated: February 26, 2025

Date Posted: April 2, 2025

Recall Number: Z-1390-2025

Event ID: 96371

Reason for Recall:

Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

Status: Ongoing

Product Quantity: 780

Code Information:

UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029

Distribution Pattern:

OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan

Voluntary or Mandated:

Voluntary: Firm initiated