Food, drugs, devices › Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Device recall: Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers:…
Covidien LP (formerly Nellcor Puritan Bennett Inc.) (Boulder, CO) initiated this device recall on 8 May 2015; FDA lists 2 product records under event 71197, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 12 Apr 2017. Initiation: voluntary: firm initiated. Covidien LP (formerly Nellcor Puritan Bennett Inc.) has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO.
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."
Distribution
"Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1950-2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers:… | 69,461 units total | Class I | Terminated | 15 Jul 2015 |
| Z-1951-2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements. | 69,461 units total | Class I | Terminated | 15 Jul 2015 |
Context
Other enforcement events for Covidien LP (formerly Nellcor Puritan Bennett Inc.)
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Jan 2016 | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pe | Device | Class II | 1 |
| 16 Jul 2015 | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for | Device | Class I | 1 |
| 29 Jun 2015 | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional | Device | Class II | 2 |
| 12 Jan 2015 | Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator Sy | Device | Class II | 1 |
All 5 events for Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 effect on oxygen levels."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.