Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published August 18, 2026

Intrapulmonary Percussive Ventilation May Cause Anesthetic Effects Changes

Percussionaire Corporation recalls Intrapulmonary Percussive Ventilation (IPV) HC due to risk of altered anesthetic delivery causing hypertonia, hypotonia, tachycardia, bradycardia, elevated intracranial pressure, or awareness during anesthesia.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3325-2026Medical devicePercussionaire Corporation ›
✎ GovInfoNow plain-language explainer

Percussionaire Corporation is recalling Intrapulmonary Percussive Ventilation (IPV) HC devices because they can interfere with anesthetic delivery systems, potentially causing dangerous medical effects during surgery. This recall affects 419 units sold worldwide. Read more at govinfonow.com/recall/1449341-percussionaire-corporation-recalls-intrapulmonary-percussive-ventilation-ipv-hc-product-number.

Source Summary by GovInfoNow · govinfonow.com/recall/1449341-percussionaire-corporation-recalls-intrapulmonary-percussive-ventilation-ipv-hc-product-number · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3325-2026

Cite this page

“Intrapulmonary Percussive Ventilation May Cause Anesthetic Effects Changes.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449341-percussionaire-corporation-recalls-intrapulmonary-percussive-ventilation-ipv-hc-product-number. Based on FDA recall #Z-3325-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3325-2026%22&limit=1).

The FDA announced on August 18, 2026, that Percussionaire Corporation is recalling its Intrapulmonary Percussive Ventilation (IPV HC) and Phasitron devices due to labeling errors. The updated warnings address risks of altered anesthetic effects when used with volatile anesthetic delivery systems.

How to tell if you have it

  • Brand: Percussionaire Corporation
  • Product: Intrapulmonary Percussive Ventilation, IPV HC; Product Number: S00009
  • Product: Phasitron, P5-HC
  • Product/Catalog Number/UDI-DI: S00009/00849436000358
  • Product/Catalog Number/UDI-DI: P5-HC/00849436000525

The hazard

The recall addresses labeling that failed to warn against using Intrapulmonary percussive ventilation (IPV) with volatile anesthetic delivery systems. This omission may result in deeper or lighter anesthetic effects, leading to hypertonia/hypotonia, tachycardia/bradycardia, elevated intracranial pressure, awareness during anesthesia, or oversedation.

Context

GovInfoNow's records show Percussionaire Corporation has issued seven other recalls since September 14, 2020. Recent brand recalls include a September 17, 2025 recall of the Phasitron 5 In-Line Valve for respiratory failure risk and a December 23, 2024 recall of VDR4 Breathing Circuits for stuck venturi components. Other recent recalls of similar products include Bard PowerPICC Catheters (May 21, 2026) and Olympus UHI-4 Insufflation Units (June 16, 2026).

How to tell if you have this one

Check for the product number S00009 on the IPV HC device or the catalog number P5-HC on the Phasitron device. These were sold globally starting from 2026.

  • Brand
    Percussionaire Corporation
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    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.
Recall numberProduct, codes & lotsQuantity
Z-3319-2026Intrapulmonary 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; Product Number/UDI-DI: S00065/00849436000679, 00849436000709; P5-UC/00849436000686 In-Line Valve Instruction Manual: P20174 Rev D61,858
Z-3320-2026In-Line Valve, Product Number: P5-TEE; UDI: 0084943600072398,434
Z-3321-2026Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual; Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20045 Rev B229,105
Z-3322-2026Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual; Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20046 Rev A229,430
Z-3323-2026Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual; Product Number/UDI-DI: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E228,277
Z-3324-2026Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual; Product Number/UDI-DI: S00055/00849436000242, P5/00849436000501, Instruction Manual: P20106 Rev B228,596
Z-3325-2026Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC; Product/Catalog Number/UDI-DI: S00009/00849436000358, P5-HC/00849436000525419
Based on the official FDA remedy

What to do — step by step

  1. Check Device Label

    Look for the product number S00009 on the IPV HC device or catalog number P5-HC on the Phasitron device.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 48 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Aug 18, 202612. FDA classified it Class II: Sep 28, 202623. Published in FDA’s Enforcement Report: Oct 7, 202634. Added to GovInfoNow: Oct 13, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

When was this recall issued?

This recall was issued on August 18, 2026.

Similar recalls

Smiths Medical Pneupac paraPAC Plus 310 Ventilator Kit Recall: Tidal Volume Knob Risk
Smiths MedicalSafeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.

Latest medical device recalls

Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS
Tandem Diabetes Care · July 16, 2026BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3325-2026 (August 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3325-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA