Recall Register

Respironics California, LLC: FDA recalls

FDA enforcement reports name Respironics California, LLC as the recalling firm in 8 events. The events have 46 product records. The recalls started from 2019 to 2022. 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

8 events, newest first.

FDA enforcement events of Respironics California, LLC
InitiatedProduct (first record)TypeClassRecordsStatus
28 Feb 2022Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)DeviceClass I3Ongoing
24 Jan 2022Philips Respironics V60 Ventilator Part Number 1053617DeviceClass I2Ongoing
18 Jun 2021Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic…DeviceClass I2Ongoing
6 Jan 2021PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.DeviceClass II1Ongoing
2 Nov 2020Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.DeviceClass II16Ongoing
30 Oct 2020Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.DeviceClass II17Terminated
5 Mar 2020Philips V60 Ventilators with Power Management PCBA part number 1055906DeviceClass II1Ongoing
11 Sep 2019Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614DeviceClass II4Ongoing

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

Respironics California, LLC: events for each product type
TypeEvents
Device8
Respironics California, LLC: events in each class
ClassEvents
Class II5
Class I3
Share of the events of the firm in Class I
38%
Share of all events on the register in Class I
18%
Events with the status Ongoing
7

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 Respironics California, LLC, by the year that the recall started. The largest year is 2020, with 3 events.

Official channels

Cite this page

Recall Register. Respironics California, LLC: FDA recalls. https://recallregister.com/firm/respironics-california-llc/. 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
CA

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 Respironics California, LLC have?
Class II: 5 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 Respironics California, LLC?
FDA event 89767, which the firm started on 28 Feb 2022. The first product in the record is: Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
How many FDA recalls of Respironics California, LLC have the status Ongoing?
7 events have 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.