Physio-Control, Inc.
FDA Regulatory Profile
Physio-Control, Inc. appears in FDA public data with 41 recalls — including 7 Class I (most serious) —, 94 510(k) clearances, 13 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2065-2026, Class II) was initiated on April 13, 2026. Its most recent 510(k) clearance was granted on October 14, 2025.
Summary
- Total Recalls
- 41 (7 Class I)
- 510(k) Clearances
- 94
- Inspections
- 13
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2065-2026 | Class II | LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, | April 13, 2026 |
| Z-1544-2026 | Class II | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 | January 21, 2026 |
| Z-2498-2025 | Class II | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 3203 | July 22, 2025 |
| Z-2499-2025 | Class II | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPA | July 22, 2025 |
| Z-2497-2025 | Class II | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2 | July 22, 2025 |
| Z-1232-2025 | Class II | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arres | February 3, 2025 |
| Z-1102-2025 | Class II | LIFEPAK 35 ECG cable REF 11111-000041 | January 21, 2025 |
| Z-1184-2025 | Class II | LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhe | January 21, 2025 |
| Z-0230-2025 | Class II | LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-00 | August 30, 2024 |
| Z-0142-2025 | Class II | STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES | August 9, 2024 |
| Z-0567-2024 | Class II | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 | November 6, 2023 |
| Z-0297-2024 | Class II | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 | September 29, 2023 |
| Z-0299-2024 | Class II | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 | September 29, 2023 |
| Z-0303-2024 | Class II | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 | September 29, 2023 |
| Z-0301-2024 | Class II | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 | September 29, 2023 |
| Z-0305-2024 | Class II | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 | September 29, 2023 |
| Z-0298-2024 | Class II | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 | September 29, 2023 |
| Z-0304-2024 | Class II | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 | September 29, 2023 |
| Z-0302-2024 | Class II | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 | September 29, 2023 |
| Z-0300-2024 | Class II | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 | September 29, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | October 14, 2025 |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure | April 30, 2024 |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | June 3, 2019 |
| K142430 | LIFEPAK 15 monitor/defibrillator | December 19, 2014 |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR | August 21, 2013 |
| K123597 | TRUECPR COACHING DEVICE | April 17, 2013 |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | October 11, 2012 |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | March 22, 2011 |
| K102972 | LIFEPAK 12 | December 22, 2010 |
| K102757 | LIFENET SYSTEM | November 5, 2010 |
| K093925 | LIFENET SYSTEM | January 12, 2010 |
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | March 11, 2009 |
| K073089 | LIFEPAK 20E | July 29, 2008 |
| K991910 | LIFEPAK 12 BIPHASIC | September 3, 1999 |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | September 1, 1999 |
| K983393 | LIFEPAK 500 BIPHASIC | May 5, 1999 |
| K973486 | LIFE PAK 12 | January 9, 1998 |
| K962359 | LIFEPAK 300 | November 6, 1997 |
| K955854 | LIFEPAK 500 | November 4, 1996 |
| K953204 | PEDIATRIC QUIK-COMBO | January 11, 1996 |