Physio-Control, Inc.
19 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Physio-Control, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-10FDA-DeviceClass IILIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest pa
Due to required inspections not being performed on products/units that have gone through servicing.
- 2025-09-10FDA-DeviceClass IILIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm
Due to required inspections not being performed on products/units that have gone through servicing.
- 2025-09-10FDA-DeviceClass IILIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when
Due to required inspections not being performed on products/units that have gone through servicing.
- 2025-03-05FDA-DeviceClass IILIFEPAK 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.
- 2025-02-26FDA-DeviceClass IILIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rai
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
- 2025-02-12FDA-DeviceClass IILIFEPAK 35 ECG cable REF 11111-000041
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
- 2024-11-06FDA-DeviceClass IILIFEPAK 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.
Due to an out of tolerance tool being used on monitor/defibrillator systems.
- 2024-10-30FDA-DeviceClass IISTERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycar
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.
- 2023-12-27FDA-DeviceClass IIAC 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.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- 2023-11-22FDA-DeviceClass IILIFEPAK 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.
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