Redmond, WA, United States
Physio-Control, Inc. recalls
17 recalls recorded since 2018, most recently on 13 April 2026. 11 are listed as ongoing. Status and classification are as published by the FDA.
Recalls17
Ongoing (FDA)11
Terminated or completed6
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 13 April 2026
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2065-2026
- LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-0
Ongoing Class II Medical devices
- Recall started
- 21 January 2026
- Reason
- Due to pediatric defibrillator electrode delamination
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Australia, Canada,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1544-2026
- PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy
Ongoing Class II Medical devices
- Recall started
- 22 July 2025
- Reason
- Due to required inspections not being performed on products/units that have gone through servicing.
- Distribution
- U.S. Nationwide distribution in the states of CO and MT.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2499-2025, Z-2497-2025, Z-2498-2025
- LIFEPAK 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.
- LIFEPAK 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 / 8838739
- LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator
Ongoing Class II Medical devices
- Recall started
- 3 February 2025
- Reason
- Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- Distribution
- U.S.: WV O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1232-2025
- LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Ongoing Class II Medical devices
- Recall started
- 21 January 2025
- Reason
- Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
- Distribution
- U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MS, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1184-2025
- LIFEPAK 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¿
Ongoing Class II Medical devices
- Recall started
- 21 January 2025
- Reason
- Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1102-2025
- LIFEPAK 35 ECG cable REF 11111-000041
Ongoing Class II Medical devices
- Recall started
- 30 August 2024
- Reason
- Due to an out of tolerance tool being used on monitor/defibrillator systems.
- Distribution
- U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0230-2025
- 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 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o
Ongoing Class II Medical devices
- Recall started
- 9 August 2024
- Reason
- 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.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0142-2025
- STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricula
Ongoing Class II Medical devices
- Recall started
- 6 November 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0567-2024
- AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Ongoing Class II Medical devices
- Recall started
- 29 September 2023
- Reason
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Distribution
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0296-2024, Z-0298-2024, Z-0303-2024, Z-0305-2024, Z-0300-2024, Z-0302-2024, Z-0299-2024, Z-0297-2024, Z-0304-2024, Z-0301-2024
- LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
- LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
- LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
- LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
- LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
- LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
- LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
- LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
- and 2 more product lines
Terminated Class III Medical devices
- Recall started
- 13 January 2022
- Terminated
- 19 May 2023
- Reason
- Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
- Distribution
- U.S.: AK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0745-2022
- HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Ongoing Class II Medical devices
- Recall started
- 14 January 2021
- Reason
- Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
- Distribution
- Worldwide Distribution to U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI , SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV and WY O.U.S. coun
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1189-2021
- PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model
Terminated Class II Medical devices
- Recall started
- 24 April 2020
- Terminated
- 27 July 2023
- Reason
- Packaging of infant child reduced energy electrodes was not properly sealed.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA, AZ, NJ, MA, MO, NC, MD, OH, PA, CA, IA, VA, WI, MN, SC, IN, DE, KY, MT, AL, MS, NM, ME, OK, WV, SD, RI, ND, LA, AR, HI, DC, KS, NE, VT, OR, AK, NV, UT, WY, NH, PR, ID, and the countr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2360-2020, Z-2359-2020
- Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defi
- Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to
Terminated Class II Medical devices
- Recall started
- 20 March 2020
- Terminated
- 25 January 2024
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Afghanistan, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Con
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1633-2020
- LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisor
Terminated Class II Medical devices
- Recall started
- 20 December 2019
- Terminated
- 4 October 2022
- Reason
- 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.
- Distribution
- Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0816-2020, Z-0817-2020
- LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
- LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Terminated Class I Medical devices
- Recall started
- 1 February 2019
- Terminated
- 18 April 2024
- Reason
- 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.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0862-2019, Z-0863-2019
- LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) pa
- LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life sup
Terminated Class I Medical devices
- Recall started
- 4 December 2017
- Terminated
- 1 April 2024
- Reason
- Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0294-2018
- LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physici
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.