Z-1950-2015Class I

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers...

Name: Z-1950-2015 Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers...
Creator: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Published: 2015-05-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-05-08 / Terminated / root cause: design

FDA source

Covidien LP (formerly Nellcor Puritan Bennett Inc.) began a recall of Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers... on 2015-05-08. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1950-2015
Classification: Class I
Status: Terminated
Initiated: 2015-05-08
Posted: 2015-07-09
Terminated: 2017-04-12
Recalling firm: Medtronic, Inc.
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,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,
Product code: JOH Tube Tracheostomy And Tube Cuff
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.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified 5/8/15 via letter. Consignees were asked to return products.
Quantity in commerce: 69,461 units total
Distribution: Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Product codes and lots: All products manufactured since 2/2012. Including All lot numbers beginning with 12, 13 and 14.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1950-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1950-2015	Class I	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-09
Z-1951-2015	Class I	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-09

Product code JOH

K142298Class IIShiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien / cleared 2015-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)