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.

26–43 of 43

  • HighFDA (Devices)·Z-1633-2020·2020-04-08

    Physio-Control Recalls LifePAK 500 AEDs Due to Contact Plating Wear

    Physio-Control is recalling 173,459 LifePAK 500 AEDs because mechanical wear on the therapy connector may prevent the device from detecting a patient, potentially delaying treatment.

    Product
    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 Advisory System. This software algorithm analyzes the patient s ele
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0817-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

    Physio-Control is recalling 705 LIFEPAK 15 Monitor/Defibrillator service kits because oxidation may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Keypad Oxidation

    Physio-Control is recalling 29,952 LIFEPAK 15 Monitor/Defibrillators worldwide because oxidation on the keypad may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2019·2019-03-06

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Lockup Condition

    Physio-Control is recalling 13,005 LIFEPAK 15 Monitor/Defibrillators because they may lock up after delivering a shock, leaving the display blank and unresponsive.

    Product
    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) patient management protocols. The LP15 monitor/defibrillator i
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0863-2019·2019-03-06

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

    Physio-Control is recalling 682 LIFEPAK 15 Monitor/Defibrillator service kits because they may lock up after delivering a shock, leaving the monitor display blank.

    Product
    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 support (ALS) patient management protocols. The LP15 monitor/de
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0294-2018·2018-01-17

    Physio-Control Recalls LIFEPAK 20e Defibrillators Due to Power Failures

    Physio-Control is recalling 3,831 LIFEPAK 20e defibrillators because power-related failures could prevent the device from delivering therapy, potentially causing serious injury or death.

    Product
    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 physician/medical director. It is intended for use on a crash cart
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0187-2018·2017-12-20

    Physio-Control Recalls LIFEPAK Electrode Starter Kits Due to Labeling Errors

    Physio-Control is recalling 14,219 LIFEPAK Electrode Starter Kits because the infant artwork shows incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0186-2018·2017-12-20

    Physio-Control Recalls Defibrillation Electrodes Due to Incorrect Pad Placement Artwork

    Physio-Control is recalling 14,219 LIFEPAK defibrillation electrodes because the artwork instructs incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1257-2017·2017-03-15

    Physio-Control Recalls LIFEPAK 1000 Defibrillators for Unexpected Power-Offs

    Physio-Control is recalling 133,330 LIFEPAK 1000 defibrillators worldwide because they may unexpectedly power off during use.

    Product
    The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2017·2017-02-22

    Physio-Control Recalls LIFEPAK 15 Defibrillators Due to Relay Failure

    Physio-Control is recalling 338 LIFEPAK 15 defibrillators because an internal relay may fail, preventing the device from delivering defibrillation energy.

    Product
    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1144-2017·2017-02-15

    Physio-Control Recalls LIFEPAK 15 Defibrillators with Erroneous CO2 Readings

    Physio-Control is recalling LIFEPAK 15 Monitor/Defibrillators with End-Tidal CO2 options because the CO2 reading may intermittently display an incorrect value of XXX.

    Product
    LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1143-2017·2017-02-15

    Physio-Control Recalls LIFEPAK 12 Defibrillators with Erratic CO2 Readings

    Physio-Control is recalling LIFEPAK 12 Defibrillators because the End-Tidal CO2 reading may intermittently display an invalid value of XXX during operation.

    Product
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0761-2017·2016-12-21

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss

    Physio-Control is recalling 1,399 LIFEPAK 15 monitor/defibrillators because they may power down unexpectedly during use.

    Product
    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2100-2016·2016-07-06

    Physio-Control Recalls LIFEPAK AEDs Due to Shock Delivery Failure Risk

    Physio-Control is recalling LIFEPAK CR Plus and EXPRESS AEDs because a faulty component may prevent the device from delivering a shock during cardiac arrest.

    Product
    LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2016·2016-06-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Display Obstruction

    Physio-Control is recalling LIFEPAK 15 monitor/defibrillators with the EtCO2 feature because the respiratory rate display may obscure the leading digit of the EtCO2 value.

    Product
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical pe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1660-2014·2014-06-04

    Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns

    Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.

    Product
    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2013·2013-07-31

    Physio Control Recalls LIFEPAK 500 AEDs Due to Assembly Error

    Physio Control is recalling 139 LIFEPAK 500 AEDs because an assembly error could cause internal shorting, rendering the device inoperable.

    Product
    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2013·2013-04-17

    Physio Control Recalls LIFEPAK Defibrillators Due to Battery Depletion Risk

    Physio Control is recalling LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators because they may experience early internal battery depletion.

    Product
    The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
    Category
    Medical Device
    Distribution
    0 states

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.