- Recalling firm
- Percussionaire Corporation
- 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
- Affected products (lot / model / serial)
- Product Number/UDI-DI: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E
- Units affected
- 228,277
- Distribution pattern
- 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.
- Firm location
- Sandpoint, ID, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3323-2026
- Recall initiated
- August 18, 2026
- FDA classification date
- September 28, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99617
- Last updated on HTM Vibe
- October 13, 2026
