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Physio-Control, Inc. FDA Recalls
23 recalls on file across devices, 0 of them Class I and 22 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577Class IIApr 13, 2026Some defibrillators serviced between July 2023 through Novem |
| PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 0072190Class IIJan 21, 2026Due to pediatric defibrillator electrode delamination |
| LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CClass IIJul 22, 2025Due to required inspections not being performed on products/ |
| LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000Class IIJul 22, 2025Due to required inspections not being performed on products/ |
| LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000Class IIJul 22, 2025Due to required inspections not being performed on products/ |
| LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.Class IIFeb 3, 2025Incorrect keypad was incorrectly installed onto a defibrilla |
| LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 119Class IIJan 21, 2025Due to an error message that prevents users from utilizing c |
| LIFEPAK 35 ECG cable REF 11111-000041Class IIJan 21, 2025Product shipped with incorrect IFU. IFU does not include pr |
| LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076Class IIAug 30, 2024Due to an out of tolerance tool being used on monitor/defibr |
| STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 DefibrilClass IIAug 9, 2024Due to customer complaints and out of box failures, the firm |
| AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098Class IINov 6, 2023AC Power Adapter (ACPA) may not charge the monitor/defibrill |
| LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020Class IISep 29, 2023Their is a potential for battery pins to become loose within |
| HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-PakClass IIIJan 13, 2022Semi-automatic defibrillators shipped out by Stryker without |
| PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoClass IIJan 14, 2021Due to complaints received regarding missing lid magnets whi |