Class I — Bunnell, Inc.
| Recalling firm | BUNNELL INCORPORATED |
|---|---|
| Registered facility | Cutler Campus (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012. |
| Product | Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who … |
| Quantity | 5743 patient circuits distributed in commerce |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only). |
| Initiated | 2012-11-19 |
| Classified | 2012-12-14 |
| Terminated | 2014-02-21 |
| Recall number | Z-0514-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Bunnell, Inc. (Z-0514-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63710/
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