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Stop using now Medical device recall · FDA · Published December 12, 2023

Percussionaire High Frequency Transport Breathing Circuit Kit Recall: Pressure Output Risk

Percussionaire recalls High Frequency Transport Phasitron Breathing Circuit Kit REF A50605-D (Rx Only) due to assembly errors causing potential severe pressure output issues. Affected units have specific lot numbers and were sold with CE 0123 marking.

🇺🇸 FDA recall #Z-0637-2024Medical devicePercussionaire ›
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Recalling firmPercussionaire Corporation130 Mcghee Rd Ste 109 · Sandpoint, ID 83864-8409
✎ GovInfoNow plain-language explainer

What happened, in plain English

Percussionaire is recalling a high-frequency breathing circuit kit that may have assembly errors causing dangerous pressure output. This could lead to severe harm to patients using the device. Affected units have specific lot numbers and were sold with CE 0123 marking. Read more at govinfonow.com/recall/56567-percussionaire-high-frequency-transport-breathing-circuit-kit-recall-pressure-output.

Source Summary by GovInfoNow · govinfonow.com/recall/56567-percussionaire-high-frequency-transport-breathing-circuit-kit-recall-pressure-output · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0637-2024

Cite this page

“Percussionaire High Frequency Transport Breathing Circuit Kit Recall: Pressure Output Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56567-percussionaire-high-frequency-transport-breathing-circuit-kit-recall-pressure-output. Based on FDA recall #Z-0637-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2024%22&limit=1).

Why it’s dangerous

The breathing circuit kit has an assembly error that can cause its pressure output to be affected. This may result in severe impacts to the end user, meaning patients could experience serious harm from the device.

Who’s affected

Healthcare professionals using the Percussionaire High Frequency Transport Phasitron Breathing Circuit Kit for medical purposes are most at risk. Patients receiving treatment with this device could be harmed by the pressure issues.

How to tell if you have this one

Check for the model REF: A50605-D (Rx Only) with CE 0123 marking. Affected units have specific lot numbers: WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930, WO06028.

  • Brand
    Percussionaire
  • Product
    High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately stop using the Percussionaire High Frequency Transport Phasitron Breathing Circuit Kit if it has the affected lot numbers listed.

Where it went and when

Where it was distributed

Distributed in 21 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, New Jersey, North Carolina, Ohio, Oregon, Tennessee, Texas, Utah, Virginia.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Dec 12, 202312. FDA classified it Class I: Jan 17, 202423. Published in FDA’s Enforcement Report: Jan 24, 2024320232024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

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

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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-0637-2024 (December 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0637-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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