Physio-Control recalls
11 official recalls and safety alerts involving Physio-Control since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Physio-Control or the relevant agency.
- 2026-05-13
USPhysio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957,…
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…
FDA · DevicePhysio-Control, Inc.US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA,…Official notice →- 2026-03-18
- US
Physio-Control, Inc. recalls PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog…
Due to pediatric defibrillator electrode delamination
FDA · DevicePhysio-Control, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2025-09-10
- US
Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is…
Due to required inspections not being performed on products/units that have gone through servicing.
FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution in the states of CO and MT.Official notice → - 2025-03-05
- US
Physio-Control, Inc. recalls LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- 2025-02-26
- US
Physio-Control, Inc. recalls LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿…
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA,…Official notice → - 2025-02-12
- US
Physio-Control, Inc. recalls LIFEPAK 35 ECG cable REF 11111-000041
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI,…Official notice → - 2024-11-06
- US
Physio-Control, Inc. recalls 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…
Due to an out of tolerance tool being used on monitor/defibrillator systems.
- 2024-10-30
- US
Physio-Control, Inc. recalls STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated…
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.
FDA · DevicePhysio-Control, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2023-12-27
- US
Physio-Control, Inc. recalls AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
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.
FDA · DevicePhysio-Control, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - 2023-11-22
- US
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
FDA · DevicePhysio-Control, Inc.US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.Official notice → - 2022-03-16
- US
Physio-Control, Inc. recalls HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.