Severity
Critical
FDA Devices recall · Reported March 30, 2022
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…
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 ….
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.
This FDA Devices action (record #Z-0785-2022) was formally reported on March 30, 2022, with the manufacturer initiating the action on June 12, 2018. It is classified under Critical severity (Class I), with a current status of Ongoing. Philips Respironics, Inc. is listed as the recalling firm, operating out of Murrysville, PA. Federal records list the affected scope as 229,353 devices, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 correc… Distribution data in the federal record shows the product reached: Global Distribution. US Nationwide.. Distribution scope 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.
Where this recall sits in its category — 40,409 medical devices recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. 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.
Severity
Critical
Affected scope
229,353 devices
Related Recalls
6
6 from same agency
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 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.
| 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
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.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 30, 2022.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.