Physio Control recalls
Physio Control appears in 43 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 43 |
|---|---|
| Published | 2013-04-17 to 2026-05-13 |
| By agency | FDA Device (43) |
| By classification | Class II (35), Class I (7), Class III (1) |
| By status | ongoing (22), terminated (21) |
| Distribution named in notices | AK, CT, GA, MA, NY, OH, US, WA, WV |
Recalls
- LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-0019…
FDA Device · Class II · 2026-05-13 · Physio Control
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 intend… - PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Numbe…
FDA Device · Class II · 2026-03-18 · Physio Control
Reason: Due to pediatric defibrillator electrode delamination - LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indi…
FDA Device · Class II · 2025-09-10 · Physio Control
Reason: Due to required inspections not being performed on products/units that have gone through servicing. - LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-…
FDA Device · Class II · 2025-09-10 · Physio Control
Reason: Due to required inspections not being performed on products/units that have gone through servicing. - LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33…
FDA Device · Class II · 2025-09-10 · Physio Control
Reason: Due to required inspections not being performed on products/units that have gone through servicing. - LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest
FDA Device · Class II · 2025-03-05 · Physio Control
Reason: Incorrect keypad was incorrectly installed onto a defibrillator/monitor. - LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS…
FDA Device · Class II · 2025-02-26 · Physio Control
Reason: Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. - LIFEPAK 35 ECG cable REF 11111-000041
FDA Device · Class II · 2025-02-12 · Physio Control
Reason: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions - 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-…
FDA Device · Class II · 2024-11-06 · Physio Control
Reason: Due to an out of tolerance tool being used on monitor/defibrillator systems. - STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for…
FDA Device · Class II · 2024-10-30 · Physio Control
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. - AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
FDA Device · Class II · 2023-12-27 · Physio Control
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. - LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
FDA Device · Class II · 2023-11-22 · Physio Control
Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. - HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
FDA Device · Class III · 2022-03-16 · Physio Control
Reason: Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. - PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary e…
FDA Device · Class II · 2021-03-17 · Physio Control
Reason: Due to complaints received regarding missing lid magnets which may result in premature battery depletion. - Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK…
FDA Device · Class II · 2020-06-17 · Physio Control
Reason: Packaging of infant child reduced energy electrodes was not properly sealed. - Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defib…
FDA Device · Class II · 2020-06-17 · Physio Control
Reason: Packaging of infant child reduced energy electrodes was not properly sealed. - LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIF…
FDA Device · Class II · 2020-04-08 · Physio Control
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… - LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad
FDA Device · Class II · 2020-01-22 · Physio Control
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. - LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
FDA Device · Class II · 2020-01-22 · Physio Control
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. - LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac car…
FDA Device · Class I · 2019-03-06 · Physio Control
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 de… - LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response sy…
FDA Device · Class I · 2019-03-06 · Physio Control
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 de… - LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physic…
FDA Device · Class I · 2018-01-17 · Physio Control
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… - LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXP…
FDA Device · Class I · 2017-12-20 · Physio Control
Reason: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. - LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRES…
FDA Device · Class I · 2017-12-20 · Physio Control
Reason: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. - The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR a…
FDA Device · Class I · 2017-03-15 · Physio Control
Reason: The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage. - LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and…
FDA Device · Class I · 2017-02-22 · Physio Control
Reason: The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Thera… - LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option
FDA Device · Class II · 2017-02-15 · Physio Control
Reason: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. - LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option
FDA Device · Class II · 2017-02-15 · Physio Control
Reason: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. - The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within…
FDA Device · Class II · 2016-12-21 · Physio Control
Reason: Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation… - LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable
FDA Device · Class II · 2016-07-06 · Physio Control
Reason: LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that c… - LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed
FDA Device · Class II · 2016-06-22 · Physio Control
Reason: The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading di… - LIFEPAK 1000 defibrillator
FDA Device · Class II · 2014-06-04 · Physio Control
Reason: Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario h… - The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System
FDA Device · Class II · 2013-07-31 · Physio Control
Reason: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assem… - The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators
FDA Device · Class II · 2013-04-17 · Physio Control
Reason: LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.