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Physio-Control Recalls
43 recalls on record · April 17, 2013 to May 13, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 13, 2026Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577
Hazard: 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 intended use may result in potential harms such as delays or inability to provide therapy.
March 18, 2026Medical DevicesFDA
Physio-Control, Inc. recalls PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 0072190
Hazard: Due to pediatric defibrillator electrode delamination
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
March 5, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Hazard: Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
February 26, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 119
Hazard: Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
February 12, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 35 ECG cable REF 11111-000041
Hazard: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
November 6, 2024Medical DevicesFDA
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
Hazard: Due to an out of tolerance tool being used on monitor/defibrillator systems.
October 30, 2024Medical DevicesFDA
Physio-Control, Inc. recalls STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril
Hazard: 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.
December 27, 2023Medical DevicesFDA
Physio-Control, Inc. recalls AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Hazard: 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.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
November 22, 2023Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Hazard: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
March 16, 2022Medical DevicesFDA
Physio-Control, Inc. recalls HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Hazard: Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
March 17, 2021Medical DevicesFDA
Physio-Control, Inc. recalls PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdo
Hazard: Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
June 17, 2020Medical DevicesFDA
Physio-Control, Inc. recalls Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes,
Hazard: Packaging of infant child reduced energy electrodes was not properly sealed.
June 17, 2020Medical DevicesFDA
Physio-Control, Inc. recalls Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator
Hazard: Packaging of infant child reduced energy electrodes was not properly sealed.
April 8, 2020Medical DevicesFDA
Physio-Control, Inc. recalls LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Pro
Hazard: Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment
January 22, 2020Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Hazard: Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
January 22, 2020Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected
Hazard: Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
March 6, 2019Medical DevicesFDA
Physio-Control Inc recalls LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a com
Hazard: Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
March 6, 2019Medical DevicesFDA
Physio-Control Inc recalls LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute c
Hazard: Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.