Percussionaire Corporation recalls Impulsator

Recalling company

Percussionaire Corporation

Product

Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 18, 2026

Reported

Oct 7, 2026

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.

Status

Ongoing

Quantity

228,277

Lot / codes

Product Number/UDI-DI: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E

Company location

Sandpoint, ID

Recall type

Voluntary: Firm initiated

Recall number

Z-3323-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3323-2026 in the FDA Enforcement Report. Also see FDA recall press releases.