Device recall: Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE…
Class I FDA enforcement event 97374. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Percussionaire Corporation started this device recall on 17 Sep 2025. The firm address in the FDA record is in Sandpoint, ID. FDA put the recall in Class I. FDA event 97374 has 1 product record. The first FDA enforcement report date is 22 Oct 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE
Recalling firm
Percussionaire Corporation, Sandpoint, ID.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0031-2026 | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use | 59160 | Class I | Ongoing | 22 Oct 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class I
- 13%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Dec 2024 | VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Pa | Device | Class I | 1 |
| 16 Sep 2024 | Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi | Device | Class I | 1 |
| 21 Aug 2024 | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve | Device | Class I | 2 |
| 12 Dec 2023 | High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 | Device | Class I | 1 |
| 28 Mar 2023 | Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) | Device | Class I | 1 |
| 14 Sep 2020 | Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0031-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 97374. https://recallregister.com/fda/i/97374/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE
- What quantity of product is in FDA event 97374?
- The FDA record gives this quantity:
59160
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 13% of the 945 device events that started in 2025 are in Class I.