FDA Medical devices recall ·
LIFEPAK 15 Part recall
- Recall number
- Z-2497-2025
- Date
- (initiated July 22, 2025)
- Company / brand
- Physio-Control, Inc.
11811 Willows Rd Ne, Redmond, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Why was it recalled?
Due to required inspections not being performed on products/units that have gone through servicing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part / Catalog Numbers / UDI-DI code / Serial Number: V15-7-000022 / 99577-001957 / 883873871690 / 49085553 V15-2-000051 / 99577-000046 / 883873988022 / 38154524 V15-2-000099 / 99577-000093 / 883873979020 / 39059475 V15-2-001603 / 99577-001256 / 883873911631 / 40973093
Distribution
U.S. Nationwide distribution in the states of CO and MT.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2497-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.