The Recall Desk

Manufacturer

Physio-Control, Inc.

43 recalls in our database name Physio-Control, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
43
Critical
1
Severe
3
Most recent
2026-05-13

Of the 43 recalls from Physio-Control, Inc. we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 43

  • HighFDA (Devices)·Z-2065-2026·2026-05-13

    Physio-Control Defibrillators May Lack Required Performance Inspection

    Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.

    Product
    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, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-00193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2026·2026-03-18

    Infant and child defibrillator electrodes recalled over pediatric electrode delamination

    Physio-Control is recalling Infant/Child Reduced Energy Defibrillator Electrodes, catalogue numbers 11101-000016 and 11101-000017, due to pediatric defibrillator electrode delamination.

    Product
    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 Defibrillation Electrodes are pre gelled, self-adhesive, the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2498-2025·2025-09-10

    LIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing

    Three LIFEPAK 1000 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK 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 cardio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2025·2025-09-10

    Defibrillator recalled because required post-service inspections were not performed

    One LIFEPAK CR2 defibrillator is recalled because required inspections were not performed on units that had gone through servicing.

    Product
    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. The patient must be unresponsive (unconscious), not breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2497-2025·2025-09-10

    LIFEPAK 15 defibrillators recalled because post-service inspections were not performed

    Four LIFEPAK 15 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.

    Product
    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 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2025·2025-03-05

    LIFEPAK 20e Defibrillator Recalled for Incorrect Keypad Installation

    Physio-Control is recalling LIFEPAK 20e defibrillator/monitor units distributed in West Virginia due to incorrect keypad installation during manufacturing. The keypad error may affect device operation.

    Product
    LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1184-2025·2025-02-26

    LIFEPAK 15 Monitor Software Error Disables Sensor Monitoring

    Physio-Control is recalling 622 LIFEPAK 15 V4 monitors due to a software error that prevents monitoring of carboxyhemoglobin and methemoglobin saturation levels in affected sensors.

    Product
    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¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2025·2025-02-12

    ECG cable shipped with incomplete cleaning and disinfection instructions

    Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.

    Product
    LIFEPAK 35 ECG cable REF 11111-000041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2025·2024-11-06

    LIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect

    Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.

    Product
    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 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 int
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0142-2025·2024-10-30

    Internal Defibrillation Paddles Recalled for Cracks and Separation

    Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.

    Product
    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 ventricular fibrillation and symptomatic ventricular tachycardia. Sync
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2024·2023-12-27

    AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On

    AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.

    Product
    AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could cause power failure. Four affected units have been distributed to Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0300-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.

    Product
    LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2024·2023-11-22

    LIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins

    Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.

    Product
    LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0299-2024·2023-11-22

    LIFEPAK 15 defibrillator recalled for potential battery power loss

    Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.

    Product
    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.

    Product
    LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2024·2023-11-22

    Defibrillator battery pins may loosen, affecting power

    Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall for Battery Pin Loosening

    Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.

    Product
    LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0298-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure

    Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.

    Product
    LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0303-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0297-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0745-2022·2022-03-16

    HeartSine Samaritan PAD Defibrillator Shipped Without Battery and Pads

    Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.

    Product
    HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1189-2021·2021-03-17

    Physio-Control Recalls LIFEPAK CR2 Defibrillators Due to Missing Lid Magnets

    Physio-Control is recalling 89,763 LIFEPAK CR2 defibrillators because missing lid magnets may cause premature battery depletion.

    Product
    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 evaluates the heart rhythm and, if a shockable rhythm is det
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2020·2020-06-17

    Physio-Control Recalls Infant Defibrillation Electrodes Due to Packaging Seal Issues

    Physio-Control is recalling infant and child defibrillation electrodes because the packaging was not properly sealed. The recall affects units manufactured between August 2017 and October 2019.

    Product
    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 be used by personnel who are trained on the device operation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2020·2020-06-17

    Physio-Control Recalls Infant Child Starter Kits Due to Packaging Seal Issues

    Physio-Control is recalling 6,732 Infant Child Starter Kits because the packaging for the reduced energy electrodes was not properly sealed.

    Product
    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 defibrillator - Product Usage: intended to be used by personnel
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Physio-Control

American medical equipment company

Official website

Source: Wikidata (Q17141535), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.