Shiley Neonatal — Class I medical device recall Z-1950-2015
Terminated recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), reported 2015-07-15, distributed nationwide. Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the af
| Recall number | Z-1950-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO, United States |
| Recall initiated | 2015-05-08 |
| Classified | 2015-07-09 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2017-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CL, DE, IL, IT, JP, SA, SG, TR, UY, ZA |
| Quantity | 69,461 units |
| Model numbers | 2.5NCF, 2.5NEF, 2.5PCF, 2.5PEF, 3.0NCF, 3.0NEF, 3.0NEF-P, 3.0PCF, 3.0PEF, 3.0PEF-P, 3.5NCF, 3.5NEF, 3.5NEF-P, 3.5PCF, 3.5PEF, 3.5PEF-P, 4.0NCF, 4.0NEF, 4.0NEF-P, 4.0PCF, 4.0PEF, 4.0PEF-P, 4.5NCF, 4.5NEF, 4.5NEF-P and 17 more |
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,
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1950-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.