Recall Register

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

FDA enforcement reports name Nellcor Puritan Bennett Inc. (dba Covidien LP) as the recalling firm in 9 events. The events have 11 product records. The recalls started from 2012 to 2014. 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

9 events, newest first.

FDA enforcement events of Nellcor Puritan Bennett Inc. (dba Covidien LP)
InitiatedProduct (first record)TypeClassRecordsStatus
1 Oct 2014Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.DeviceClass I1Terminated
1 Oct 2014Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.DeviceClass I1Terminated
17 Jul 2014Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely…DeviceClass II2Terminated
4 Jun 2014Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4” Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support…DeviceClass II1Terminated
3 Jun 2014Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.DeviceClass II1Terminated
18 Apr 2014Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.DeviceClass II1Terminated
25 Jan 2013Puritan Bennett 840 Series Ventilator PB840 Operator’s Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The…DeviceClass II2Terminated
1 Aug 2012DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.DeviceClass II1Terminated
18 Jul 2012Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.…DeviceClass I1Terminated

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

Nellcor Puritan Bennett Inc. (dba Covidien LP): events for each product type
TypeEvents
Device9
Nellcor Puritan Bennett Inc. (dba Covidien LP): events in each class
ClassEvents
Class II6
Class I3
Share of the events of the firm in Class I
33%
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 Nellcor Puritan Bennett Inc. (dba Covidien LP), by the year that the recall started. The largest year is 2014, with 6 events.

Official channels

Cite this page

Recall Register. Nellcor Puritan Bennett Inc. (dba Covidien LP): FDA recalls. https://recallregister.com/firm/nellcor-puritan-bennett-inc-dba-covidien-lp/. 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 Nellcor Puritan Bennett Inc. (dba Covidien LP) have?
Class II: 6 events. Class I: 3 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 Nellcor Puritan Bennett Inc. (dba Covidien LP)?
FDA event 69324, which the firm started on 1 Oct 2014. The first product in the record is: Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
How many FDA recalls of Nellcor Puritan Bennett Inc. (dba Covidien LP) 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.