Physio-Control LIFEPAK 15 Defibrillator Recall: Out of Tolerance Tool Risk
Physio-Control recalls LIFEPAK 15 defibrillators with specific model numbers due to an out of tolerance tool used during manufacturing, potentially causing system failure.
Use caution until it’s fixed
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Contact the company
What happened, in plain English
Physio-Control is recalling specific models of LIFEPAK 15 defibrillators because an out of tolerance tool was used during manufacturing. This could lead to system failure during use, which is serious for medical devices. Read more at govinfonow.com/recall/54141-physio-control-lifepak-15-defibrillator-recall-out-of-tolerance-tool.
Source Summary by GovInfoNow · govinfonow.com/recall/54141-physio-control-lifepak-15-defibrillator-recall-out-of-tolerance-tool · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0230-2025
Cite this page
“Physio-Control LIFEPAK 15 Defibrillator Recall: Out of Tolerance Tool Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54141-physio-control-lifepak-15-defibrillator-recall-out-of-tolerance-tool. Based on FDA recall #Z-0230-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0230-2025%22&limit=1).
Why it’s dangerous
An out of tolerance tool was used during manufacturing, which could cause the defibrillator system to malfunction. This might lead to system failure during critical medical procedures, such as cardiac defibrillation.
Who’s affected
Healthcare professionals using the LIFEPAK 15 defibrillators with the listed model numbers are most at risk. Patients receiving defibrillation care using these devices could be affected if the system fails.
How to tell if you have this one
Check the model numbers listed in the recall notice (e.g., 97577-000101, 99577-000046) or the serial numbers provided. The device is intended for use as a monitor/defibrillator in medical settings.
- Brand
Physio-Control- Category
Medical device
What to do — step by step
Check Device Model
Verify the model number on your LIFEPAK 15 device against the list of recalled numbers provided in the recall notice.
Contact Manufacturer
Reach out to Physio-Control directly for further assistance or to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed in 7 states.
FDA distribution: “U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, West Virginia.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0230-2025 (August 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0230-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.