{"recall":{"id":"fda-device-99617","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Percussionaire Corporation recalls 7 products","firm":"Percussionaire Corporation","date":"2026-08-18","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"Product Number/UDI-DI: S00065/00849436000679, 00849436000709; P5-UC/00849436000686 In-Line Valve Instruction Manual: P20174 Rev D","quantity":"61,858","number":"Z-3319-2026","classification":"Class II"},{"name":"In-Line Valve, Product Number: P5-TEE","code":"UDI: 00849436000723","quantity":"98,434","number":"Z-3320-2026","classification":"Class II"},{"name":"Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual","code":"Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20045 Rev B","quantity":"229,105","number":"Z-3321-2026","classification":"Class II"},{"name":"Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual","code":"Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20046 Rev A","quantity":"229,430","number":"Z-3322-2026","classification":"Class II"},{"name":"Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual","code":"Product Number/UDI-DI: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E","quantity":"228,277","number":"Z-3323-2026","classification":"Class II"},{"name":"Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual","code":"Product Number/UDI-DI: S00055/00849436000242, P5/00849436000501, Instruction Manual: P20106 Rev B","quantity":"228,596","number":"Z-3324-2026","classification":"Class II"},{"name":"Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC","code":"Product/Catalog Number/UDI-DI: S00009/00849436000358, P5-HC/00849436000525","quantity":"419","number":"Z-3325-2026","classification":"Class II"}],"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","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"61,858; 98,434; 229,105; 229,430; 228,277; 228,596; 419","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99617","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"9e00875a967551ff","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99617","record":[{"status":"Ongoing","city":"Sandpoint","state":"ID","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99617","recalling_firm":"Percussionaire Corporation","address_1":"130 Mcghee Rd Ste 109","address_2":"","postal_code":"83864-8409","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-3319-2026","product_description":"Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; 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 Phasitron 5, Product Number: P5 used with Instruction Manual","product_quantity":"229,105","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","recall_initiation_date":"20260818","center_classification_date":"20260928","report_date":"20261007","code_info":"Product Number/UDI-DI:  S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648;  P5/00849436000501;  Instruction Manual: P20045 Rev B","more_code_info":""},{"status":"Ongoing","city":"Sandpoint","state":"ID","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99617","recalling_firm":"Percussionaire Corporation","address_1":"130 Mcghee Rd Ste 109","address_2":"","postal_code":"83864-8409","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-3322-2026","product_description":"Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; 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