Physio-Control LIFEPAK 15
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Physio-Control, Inc. of Redmond, Washington is recalling LIFEPAK 15, LIFEPAK 1000, LIFEPAK 35, and LIFEPAK 20e defibrillators serviced between July 2023 through November 2025 because they were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted.
The inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy. The recall began April 13, 2026, and was added to the FDA's Enforcement Report on May 4, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045;
LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096;
LIFEPAK 35, REF: 99335-000013, 99335-000031;
LIFEPAK 20e, REF: 99507-000122- UDI-DI
- 0088387387168
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Michigan, Washington, Kentucky, Indiana, Florida, North Carolina, Texas, Louisiana, Virginia, New York, Massachusetts, Colorado, Pennsylvania, Ohio, South Carolina, Oklahoma, Minnesota, West Virginia, New Jersey, Wisconsin.
- Event ID
- 98418
- Recall No.
- Z-2065-2026
- Company
- Physio-Control, Inc.Redmond, Washington
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
