Six recall records for the device type "Device, Positive Pressure Breathing, Intermittent" (product code NHJ) were posted in the week from September 28 to October 5, 2026. The eight weeks before held one. All six come from a single FDA recall event, number 99617, posted on September 28.
What moved
openFDA lists seven NHJ recall records posted since August 1. One, posted September 23, is a different firm's product. The other six belong to event 99617, which covers Percussionaire Corporation's intrapulmonary percussive ventilation (IPV) systems. FDA's event page lists seven records, so one record from the same event sits under a different device type and isn't counted here.
This week's count measures one recall event split into six product records, not six separate actions.
The six records
Each record pairs a driver unit with a Phasitron breathing circuit:
- IPV 1 (S00065) with the Phasitron 5 circuit with unified connector (P5-UC), used with an in-line valve
- IPV-1C (S00002-C) with the Phasitron 5 (P5)
- IPV-2C (S00002-C) with the Phasitron 5 (P5)
- Impulsator (S00010) with the Phasitron 5 (P5)
- Travel Air (S00055) with the Phasitron 5 (P5)
- IPV HC (S00009) with the Phasitron P5-HC
All six give the same reason. The labeling was updated with a warning not to use IPV in conjunction with volatile anesthetic delivery systems, because IPV may alter controlled delivery of volatile anesthetic agents. The warning lists possible results including deeper or lighter anesthetic effects, hypertonia or hypotonia, tachycardia or bradycardia, elevated intracranial pressure, awareness during anesthesia and oversedation.
Cause category and corrective action
FDA records the root cause category for all six as Device Design. The corrective action is a labeling correction. On August 18, 2026, the firm emailed correction notices to customers and distributors saying the warning would be added to the instructions for use.
These are two different fields. The cause category is FDA's classification, and the corrective action is what the firm did. The records don't say how the issue was identified or whether adverse event reports came before the change.
Timing
The firm started the correction on August 18, and FDA posted the records on September 28. That is six weeks between the customer notice and the public record.
What this means for RA/QA teams
One correction can produce several recall records. A firm that lists each driver unit and circuit pairing separately creates a cluster from one decision, so weekly counts that don't group by event overstate the number of distinct actions.
Combined-use scenarios belong in the risk file. This warning concerns IPV used alongside a different device class in the same setting, and respiratory therapy often runs near anesthesia equipment, ventilators and monitors.
The warning lists clinical outcomes, not device failure modes. Teams should check whether their complaint and adverse event coding would surface reports that describe those outcomes alongside concurrent use of another device.
What to do with this
If you make respiratory or airway clearance products, compare your labeling with this warning and confirm that concurrent-use scenarios appear in your risk analysis. When a weekly recall count jumps, group the records by FDA event number before reading it as a trend.