Physio-Control, Inc. Recalls

All product recalls associated with Physio-Control, Inc..

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Recall Summary

Total Recalls

48

Past Year

6

Class I (Serious)

0

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 48 recalls

LIFEPAK CR2 (Physio-Control) – Inspection Failure (2025)

Due to required inspections not being performed on products/units that have gone through servicing.

FDAJul 22, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Inspection Failure (2025)

Due to required inspections not being performed on products/units that have gone through servicing.

FDAJul 22, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 1000 (Physio-Control) – Inspection Failure (2025)

Due to required inspections not being performed on products/units that have gone through servicing.

FDAJul 22, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 20e (Physio-Control) – keypad installation (2025)

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

FDAFeb 3, 2025WV• Physio-Control, Inc.

LIFEPAK 15 Masimo Sensors (Physio-Control) – sensor error (2025)

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 35 ECG Cable (Physio-Control) – incorrect instructions (2025)

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Tool Tolerance Issue (2024)

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

FDAAug 30, 2024CT, GA, MA +4 more• Physio-Control, Inc.

Sterilizable Defibrillation Paddles (Physio-Control) - Product Failure (2024)

Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.

FDAAug 9, 2024Nationwide• Physio-Control, Inc.

Physio-Control, Inc.: AC Power Adapter for use with the LIFEPAK 15 Monitor/Defi...

AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

FDANov 6, 2023Nationwide• Physio-Control, Inc.