Recall Register

Covidien LP (formerly Nellcor Puritan Bennett Inc.): FDA recalls

FDA enforcement reports name Covidien LP (formerly Nellcor Puritan Bennett Inc.) as the recalling firm in 5 events. The events have 7 product records. The recalls started from 2015 to 2016. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

5 events, newest first.

FDA enforcement events of Covidien LP (formerly Nellcor Puritan Bennett Inc.)
InitiatedProduct (first record)TypeClassRecordsStatus
15 Jan 2016Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.DeviceClass II1Terminated
16 Jul 2015Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).DeviceClass I1Terminated
29 Jun 2015OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.DeviceClass II2Terminated
8 May 2015Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers:…DeviceClass I2Terminated
12 Jan 2015Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Covidien LP (formerly Nellcor Puritan Bennett Inc.): events for each product type
TypeEvents
Device5
Covidien LP (formerly Nellcor Puritan Bennett Inc.): events in each class
ClassEvents
Class II3
Class I2
Share of the events of the firm in Class I
40%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Covidien LP (formerly Nellcor Puritan Bennett Inc.), by the year that the recall started. The largest year is 2015, with 4 events.

Official channels

Cite this page

Recall Register. Covidien LP (formerly Nellcor Puritan Bennett Inc.): FDA recalls. https://recallregister.com/firm/covidien-lp-formerly-nellcor-puritan-bennett-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CO

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Covidien LP (formerly Nellcor Puritan Bennett Inc.) have?
Class II: 3 events. Class I: 2 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Covidien LP (formerly Nellcor Puritan Bennett Inc.)?
FDA event 73096, which the firm started on 15 Jan 2016. The first product in the record is: Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
How many FDA recalls of Covidien LP (formerly Nellcor Puritan Bennett Inc.) have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.