FDA Recall of Philips Respironics Trilogy EV300 Ventilator
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 units of their Trilogy EV300 ventilator due to a potential delay in the Obstruction Alarm, which may not trigger within required standards.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 15, 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 Article
What Happened
Philips Respironics, Inc. is conducting a voluntary recall of their Trilogy EV300 ventilator because, in some situations, the Obstruction Alarm does not trigger within the timeframe required by relevant standards and may take up to four breaths.
Which Products Are Affected
The affected products are the Philips Respironics Trilogy EV300 with Software Version 1.05.15.00. This includes all model numbers, all UDIs, and all serial numbers. A total of 113,717 units are involved, distributed nationwide in the United States and to various foreign countries.
What You Should Do
Consumers who have this device and received a notification letter from Philips Respironics, Inc. should follow the instructions in the letter for further guidance on the recall process.
Why This Matters
This recall highlights a potential safety issue with a critical medical device, as a delayed alarm could lead to serious health risks for users relying on the ventilator for breathing support.
Source
This information is from the FDA recall announcement with recall number Z-1648-2026.
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 (1,113 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.