FDA Medical devices recall ·
LIFEPAK 20e recall
- Recall number
- Z-1232-2025
- Date
- (initiated February 3, 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
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Why was it recalled?
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
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
Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467
Distribution
U.S.: WV O.U.S.: N/A
States: West Virginia
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-1232-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.