Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o Recalled by Physio-Control, Inc. Due to Due to an out of tolerance tool being...

Date: August 30, 2024
Company: Physio-Control, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Physio-Control, Inc. directly.

Affected Products

LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.

Quantity: 105 systems

Why Was This Recalled?

Due to an out of tolerance tool being used on monitor/defibrillator systems.

Where Was This Sold?

This product was distributed to 7 states: CT, GA, MA, NY, OH, WA, WV

Affected (7 states)Not affected

About Physio-Control, Inc.

Physio-Control, Inc. has 38 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report