CLASS I Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy recalled
Covidien LP (formerly Nellcor Puritan Bennett Inc.) is recalling Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff, distributed nationwide in the US. The recall was initiated on 8 May 2015 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1951-2015
- FDA event ID
- 71197
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 May 2015
- FDA classified
- 9 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 May 2015 | Recall initiated by company | |
| 9 Jul 2015 | Classified by FDA | +62 days |
| 15 Jul 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Where it was distributed
Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Questions about this recall
Is Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff recalled?
Yes. Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalled Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff on 8 May 2015. The recall is Class I and its status is Terminated. Recall number Z-1951-2015.
Why was it recalled?
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.
Which lots are affected?
All products manufactured since 2/2012.
Where was it sold?
Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Covidien LP (formerly Nellcor Puritan Bennett Inc.)
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Puritan Bennett 980 Ventilator System, PB980 Ventilator recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | PR |
| Device | CLASS I | Puritan Bennett 980 Ventilator System, Universal recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | OxiMax N-65 Handheld Pulse Oximeter recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | Nationwide |
| Device | CLASS II | OxiMax N-560 Pulse Oximeter recalled by Covidien LP (formerly Nellcor | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | Nationwide |
| Device | CLASS I | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | Nationwide |
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