Recall of Philips Respironics Trilogy Evo Universal Ventilators
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Philips Respironics is recalling 113,717 Trilogy Evo Universal ventilators due to potential discrepancies in tidal volume when using non-pneumatic nebulizers, classified as a Class I recall by the FDA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
Recall of Philips Respironics Trilogy Evo Universal Ventilators
What Happened
Philips Respironics is recalling their Trilogy Evo Universal ventilators because using non-pneumatic nebulizers with these devices may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Which Products Are Affected
The affected products are the Philips Respironics Trilogy Evo Universal with Software Version 1.05.15.00. This recall involves approximately 113,717 units, with all model numbers, UDIs, and serial numbers included. The products were distributed worldwide, including nationwide in the United States and to countries such as Argentina, Australia, and Canada.
What You Should Do
Consumers who have the affected product should follow the instructions in the letter from Philips Respironics, as this is a firm-initiated voluntary recall. For returns, refunds, or further information, contact the recalling firm, Philips Respironics, Inc., at their address: 1001 Murry Ridge Ln, Murrysville, PA 15668-8517.
Why This Matters
This recall affects over 113,000 devices used for continuous home ventilation, and its Class I classification by the FDA indicates a significant potential for serious health risks.
Source
FDA Recall Notice: Z-1617-2026. For more details, refer to the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,343 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.