Life Pulse High Frequency Ventilator (HFV) recallZ-0893-06 · Bunnell, Inc. · initiated Apr 4, 2005
Terminated All recalls posted in May 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bunnell, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.
FDA root cause category: Other
What the company is doing
Notified consignees by letter on 04/04/2005.
Recall details
- Recall number
- Z-0893-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 4, 2005
- Posted by the FDA
- May 23, 2006
- Recalling firm
- Bunnell, Inc.
- Quantity
- 297 units
- Product code
- LSZ
- FDA submissions
- P850064
- Distribution
- Nationwide, Military medical center, Canada, and Czech Republic
Product description
Life Pulse High Frequency Ventilator (HFV)
Code information (models, lots, serial numbers)
Serial numbers 2585 and below.
Other devices under the same FDA submission
3 devices cleared under P850064 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Bunnell 903Bunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- LifePort 2.5 mmBunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- LifePulse 312Bunnell, Incorporated · Ventilator, High Frequency1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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