PlainRecalls
CriticalClass IOngoing

FDA Devices recall · Reported March 30, 2022

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may d…

Recall #
Z-0785-2022
Affected scope
229,353 devices
Initiated
June 12, 2018
Verify with FDA Devices →
View my saved recalls

Philips Respironics, Inc. recalled Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The devi… - a critical-severity action.

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The devi… was recalled by Philips Respironics, Inc. in March 30, 2022. Reason: In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices …. Check the official notice for the remedy. Verify recall #Z-0785-2022 with the FDA Devices before acting.

The recall

Philips Respironics, Inc. issued this critical-severity FDA Devices recall-In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices ….

Critical
severity level
229K units
affected scope
Class I
classification
March 30, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0785-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

Reason for recall

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number Z-0785-2022
Date reported March 30, 2022
Date initiated June 12, 2018
Recalling firm Philips Respironics, Inc.
Firm location Murrysville, PA
Affected scope 229,353 devices
Distribution Global Distribution. US Nationwide.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

229,353 devices units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0785-2022) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.. Recalled by Philips Respironics, Inc.. Units affected: 229,353 devices.
Why was this product recalled? ▼
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 30, 2022. Severity: Critical. Recall number: Z-0785-2022.
Where was the recalled product distributed? ▼
Distribution: Global Distribution. US Nationwide..
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported March 30, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026