The Recall Desk

Manufacturer

Respironics California, LLC

46 recalls in our database name Respironics California, LLC as the manufacturing or recalling firm.

What the numbers show

Total
46
Critical
0
Severe
9
Most recent
2022-04-27

Of the 46 recalls from Respironics California, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 46

  • SevereFDA (Devices)·Z-0909-2022·2022-04-27

    Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault

    Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.

    Product
    Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0907-2022·2022-04-27

    Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect

    Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.

    Product
    Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2022·2022-04-27

    Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk

    Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.

    Product
    Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0663-2022·2022-03-09

    Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled

    Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1138747
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0662-2022·2022-03-09

    Philips V60 Ventilator Recall: Expired Adhesive May Cause Device Failure

    A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2073-2021·2021-07-28

    Philips Respironics V60 Ventilator Flow Rate Reduction Safety Defect

    Philips Respironics V60 ventilators with High Flow Therapy software versions 3.00 and 3.10 may reduce oxygen delivery below prescribed levels when pressure limits are reached, risking oxygen desaturation.

    Product
    Philips 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: pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2074-2021·2021-07-28

    Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients

    Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.

    Product
    Philips Respironics V60 Plus 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2021·2021-03-03

    Respironics Recalls 94 Philips Ventilator Batteries Due to Design Verification Issues

    Respironics is recalling 94 Philips V60 ventilator batteries because they were shipped without proper design verification. The recall covers distribution across multiple U.S. states.

    Product
    PHILIPS 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 9,856 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Defects

    Respironics is recalling three V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect

    Respironics is recalling 10,291 V60 ventilators worldwide due to a navigation ring that may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 481 V60 Ventilators due to potential backup battery failures caused by over-discharge or extended storage without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 10,441 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2021·2021-02-03

    Philips Respironics V60 Plus Ventilator Recall Due to Navigation Ring Malfunction

    The FDA is recalling the Philips Respironics V60 Plus Ventilator because its navigation ring may become inoperative or operate intermittently, potentially causing ventilator parameter values to change erratically during setup or adjustment.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 834 V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 2,144 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 2,137 V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect

    Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 216 V60 Ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2021·2021-02-03

    Philips Respironics V60 Plus Ventilator Recalled for Backup Battery Failure

    Respironics is recalling 3,887 V60 Plus Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2021·2021-02-03

    Philips Respironics V680 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 3,453 V680 ventilators worldwide because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 3,213 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Defects

    Respironics is recalling V60 ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

    Respironics is recalling 46,313 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 534 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide