Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy… recallZ-1951-2015 · Covidien LP (formerly Nellcor Puritan Bennett Inc.) · initiated May 8, 2015
Class I Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LP (formerly Nellcor Puritan Bennett Inc.) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
Consignees were notified 5/8/15 via letter. Consignees were asked to return products.
Recall details
- Recall number
- Z-1951-2015
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- May 8, 2015
- Posted by the FDA
- Jul 9, 2015
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Quantity
- 69,461 units total
- Product code
- JOH
- FDA submissions
- K122531
- Distribution
- Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Product description
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Code information (models, lots, serial numbers)
All products manufactured since 2/2012.
Other devices under the same FDA submission
26 devices cleared under K122531 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Shiley 4.5PEFCovidien LP · Tube tracheostomy and tube cuff27 reports
- Shiley 4.0PEFCovidien LP · Tube tracheostomy and tube cuff23 reports
- Shiley 6.0PELFCovidien LP · Tube tracheostomy and tube cuff23 reports
- Shiley 5.0PEFCovidien LP · Tube tracheostomy and tube cuff22 reports
- Shiley 5.5PEFCovidien LP · Tube tracheostomy and tube cuff22 reports
- Shiley 3.5PEFCovidien LP · Tube tracheostomy and tube cuff10 reports
- Shiley 5.0PELFCovidien LP · Tube tracheostomy and tube cuff9 reports
- Shiley 6.5PELFCovidien LP · Tube tracheostomy and tube cuff9 reports
- Shiley 4.0PEFCovidien LP · Tube tracheostomy and tube cuff7 reports
- Shiley 4.5PEFCovidien LP · Tube tracheostomy and tube cuff6 reports
- Shiley 5.0PEFCovidien LP · Tube tracheostomy and tube cuff6 reports
- Shiley 5.0PELFCovidien LP · Tube tracheostomy and tube cuff6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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