CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled
Percussionaire is recalling Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065, distributed nationwide in the US. The recall was initiated on 18 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3319-2026
- FDA event ID
- 99617
- Recalling firm
- Percussionaire, Sandpoint, ID
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2026
- FDA classified
- 28 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Aug 2026 | Recall initiated by company | |
| 28 Sep 2026 | Classified by FDA | +41 days |
| 7 Oct 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Product as listed by the FDA
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
Where it was distributed
Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Which lots are affected?
Product Number/UDI-DI: S00065/00849436000679, 00849436000709; P5-UC/00849436000686 In-Line Valve Instruction Manual: P20174 Rev D
Where was it sold?
Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 99617This product is part of a recall event; the main page for the event is Intrapulmonary Percussive Ventilation, IPV HC recalled by Percussionaire.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Intrapulmonary Percussive Ventilation, IPV HC recalled by Percussionaire | Percussionaire | Other | Nationwide | |
| CLASS II | Intrapulmonary Percussive Ventilation, IPV-2C recalled by Percussionaire | Percussionaire | Other | Nationwide | |
| CLASS II | In-Line Valve, Product Number: P5-TEE recalled by Percussionaire | Percussionaire | Other | Nationwide | |
| CLASS II | Impulsator, Product Number: S00010, Phasitron recalled by Percussionaire | Percussionaire | Other | Nationwide | |
| CLASS II | Travel Air, Product Number: S00055 recalled by Percussionaire | Percussionaire | Other | Nationwide | |
| CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |
More recalls from Percussionaire
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | Travel Air, Product Number: S00055 recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | Impulsator, Product Number: S00010, Phasitron recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | In-Line Valve, Product Number: P5-TEE recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-2C recalled by Percussionaire | Percussionaire | Other | Nationwide |
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| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | Atellica CH Revised C-Reactive Protein (RCRP) recalled | Siemens Healthcare Diagnostics | Other | Nationwide |