FDA · Class II · October 7, 2026

Percussionaire recall: Intrapulmonary Percussive Ventilation and 3 more products

Percussionaire Corporation is recalling Intrapulmonary Percussive Ventilation and 3 more products – 61,858; 98,434; 229,105; 229,430; 228,277; 228,596; 419. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on August 18, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductIntrapulmonary Percussive Ventilation and 3 more products
BrandPercussionaire
CompanyPercussionaire Corporation
TypeMedical devices
ClassificationClass II
Recall dateAugust 18, 2026
Published by FDAOctober 7, 2026
Quantity61,858; 98,434; 229,105; 229,430; 228,277; 228,596; 419
Recall ID99617
As listed by FDA

Recalled products (7)

  1. 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
    FDA recall number
    Z-3319-2026
    Codes, lots and dates
    Product Number/UDI-DI: S00065/00849436000679, 00849436000709; P5-UC/00849436000686 In-Line Valve Instruction Manual: P20174 Rev D
    Quantity
    61,858
    Classification
    Class II
  2. In-Line Valve, Product Number: P5-TEE
    FDA recall number
    Z-3320-2026
    Codes, lots and dates
    UDI: 00849436000723
    Quantity
    98,434
    Classification
    Class II
  3. Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
    FDA recall number
    Z-3321-2026
    Codes, lots and dates
    Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20045 Rev B
    Quantity
    229,105
    Classification
    Class II
  4. Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
    FDA recall number
    Z-3322-2026
    Codes, lots and dates
    Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20046 Rev A
    Quantity
    229,430
    Classification
    Class II
  5. Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
    FDA recall number
    Z-3323-2026
    Codes, lots and dates
    Product Number/UDI-DI: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E
    Quantity
    228,277
    Classification
    Class II
  6. Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
    FDA recall number
    Z-3324-2026
    Codes, lots and dates
    Product Number/UDI-DI: S00055/00849436000242, P5/00849436000501, Instruction Manual: P20106 Rev B
    Quantity
    228,596
    Classification
    Class II
  7. Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
    FDA recall number
    Z-3325-2026
    Codes, lots and dates
    Product/Catalog Number/UDI-DI: S00009/00849436000358, P5-HC/00849436000525
    Quantity
    419
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99617
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Sandpoint, ID, United States

Why it was recalled

The reason the FDA lists: “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”

Where it was sold

Nationwide. Distribution as the FDA records it: “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 to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99617, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is Percussionaire Intrapulmonary Percussive Ventilation recalled?

Yes. Percussionaire Corporation recalled it on August 18, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.

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

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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