The Recall Desk
HighFDA (Devices)·Z-1950-2015·Announced 2015-07-15

Shiley Neonatal and Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

FDA is recalling Shiley Neonatal and Pediatric Tracheostomy Tubes because patients reported discomfort and breathing difficulties after switching to these products.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where injury (breathing difficulties and negative oxygen levels) has been reported, but no fatalities or hospitalizations are explicitly stated in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tubes, Cuffless, manufactured by Covidien LP (formerly Nellcor Puritan Bennett Inc.). The recall covers 69,461 units distributed worldwide, including the United States, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay. The affected products were manufactured since February 2012 and include all lot numbers beginning with 12, 13, and 14.

The recall was initiated due to reports of patients experiencing discomfort and, in some cases, breathing difficulties corresponding to a negative effect on oxygen levels. These issues occurred in patients who recently switched from current Shiley Neonatal and Pediatric products to the affected units.

Healthcare providers and patients should stop using the affected tracheostomy tubes and contact the manufacturer or their medical provider for instructions on replacement or further action.

The recalled product

Product
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0
Manufacturer
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Category
Medical Device — Tracheostomy Tubes
Hazard
Affected units
69,461

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 13 and 14.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Covidien LP (formerly Nellcor Puritan Bennett Inc.)

See all →