Class II recall Z-3319-2026: Percussionaire Corporation
Class II recall Z-3319-2026: Percussionaire Corporation (Idaho): Percussionaire Corporation. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 6 related ID FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3319-2026 |
| Recalling firm | Percussionaire Corporation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | 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 |
| 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 |
| Quantity | 61,858 |
| 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, C |
| Recall initiated | 2026-08-18 |
| Reported | 2026-10-07 |
| Firm location | Sandpoint, ID, United States |
| Peer records CSV (7 ID records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (ID first): Class II recall Z-3325-2026 · Class II recall Z-3322-2026 · Class II recall Z-3320-2026 · Class II recall Z-3323-2026 · Class II recall Z-3324-2026 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-3319-2026: Percussionaire Corporation and 7 Idaho peers
- Idaho FDAPulse records like this one: 7
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Idaho peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.
What is the FDAPulse record for Class II recall Z-3319-2026: Percussionaire Corporation in Idaho?
Class II device recall Z-3319-2026 by Percussionaire Corporation: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic
How does Class II recall Z-3319-2026: Percussionaire Corporation compare to other Idaho FDAPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
Class II recall Z-3319-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3319-2026 | ID | 2026-10-07 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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