Covidien LP (formerly Nellcor Puritan Bennett Inc.): Medical Device Recall in 2015 - (Recall #: Z-1951-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.

Product Classification:

Class I

Date Initiated: May 8, 2015

Date Posted: July 15, 2015

Recall Number: Z-1951-2015

Event ID: 71197

Reason for Recall:

Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.

Status: Terminated

Product Quantity: 69,461 units total

Code Information:

All products manufactured since 2/2012.

Distribution Pattern:

Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated