An FDA Recall Record Says a Ventilator's Obstruction Alarm May Take Up to Four Breaths in Some Situations

The U.S. Food and Drug Administration keeps a public database of medical device recalls. One record in it, recall number Z-1646-2026, is headed "Class 1 Device Recall" and covers a ventilator its product line describes as a "Continuous home-use ventilator device." It gives the date the firm initiated the recall as March 2, 2026, the date posted as April 2, 2026, and the status as open. The page was last updated on November 5, 2026. The record covers more than one failure. Parts of it follow, not the whole.

The Alarm

The record gives the manufacturer's reason for recall in one sentence. "In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths."

The record does not say how late in seconds, which situations, or which standards.

An alarm that triggers late still triggers. A test that asks only whether it triggered would pass it; the standards ask when.

The Recall as a Whole

Under "FDA Determined Cause" the record gives two words: "Software design." It gives that one cause for the record, and a footnote limits it. "Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall." The quantity in commerce is given as "113,717 units," and the distribution as "Worldwide Distribution," with a list of countries.

A footnote to the record's status says "The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes."

What the Notices Said

The record's "Action" field lists the notices by date. An important product notice was mailed to consignees on 6/5/24 "about obstruction alarm compliance failure."

An updated urgent field safety notice followed, mailed on 3/2/26 "with recall information for three failure modes." The field also describes an issue with nebulizers: using non-pneumatic nebulizers with these ventilators "may result in a discrepancy between the set tidal volume and the tidal volume received by the patient," which "can lead to under-delivery of therapy to the patient." The field then says to update all devices with software version 1.05.15.00 through two websites it names, and to stop use of non-pneumatic nebulizers with all affected devices.

A further update was mailed on 4/24/26. It "clarifies and revises guidance" about non-pneumatic nebulizers. The record then says "This does not change this previously communicated information," and lists two points: nebulized aerosol deposition on the internal flow sensor, and obstruction alarm timing.