PlainRecalls

Physio Control, Inc.

Compiled from official public sources by the editorial team.

43 recalls on record · Latest: May 13, 2026

Physio Control, Inc. Recall Insight

Physio Control, Inc. appears on 43 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.042% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 13, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 43 entries, severity tagging shows 7 critical, 35 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 43 of 43 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (43). The date window on this page runs from Apr 17, 2013 to May 13, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate May 13, 2026

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-…

FDA Devices Moderate Mar 18, 2026

PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11…

FDA Devices Moderate Sep 10, 2025

LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated…

FDA Devices Moderate Sep 10, 2025

LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-0000…

FDA Devices Moderate Sep 10, 2025

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400…

FDA Devices Moderate Mar 5, 2025

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

FDA Devices Moderate Feb 26, 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 …

FDA Devices Moderate Feb 12, 2025

LIFEPAK 35 ECG cable REF 11111-000041

FDA Devices Moderate Nov 6, 2024

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 99577-001…

FDA Devices Moderate Oct 30, 2024

STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the t…

FDA Devices Moderate Dec 27, 2023

AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023

FDA Devices Moderate Nov 22, 2023

LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020

FDA Devices Low Mar 16, 2022

HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

FDA Devices Moderate Mar 17, 2021

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary enviro…

FDA Devices Moderate Jun 17, 2020

Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 def…

FDA Devices Moderate Jun 17, 2020

Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, …

FDA Devices Moderate Apr 8, 2020

LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 A…

FDA Devices Moderate Jan 22, 2020

LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.

FDA Devices Moderate Jan 22, 2020

LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits

FDA Devices Critical Mar 6, 2019

LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system d…

FDA Devices Critical Mar 6, 2019

LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care resp…

FDA Devices Critical Jan 17, 2018

LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s …

FDA Devices Critical Dec 20, 2017

LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) A…

FDA Devices Critical Dec 20, 2017

LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R…

FDA Devices Critical Mar 15, 2017

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…

FDA Devices Critical Feb 22, 2017

LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric …

FDA Devices Moderate Feb 15, 2017

LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency…

FDA Devices Moderate Feb 15, 2017

LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency…

FDA Devices Moderate Dec 21, 2016

The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the envir…

FDA Devices Moderate Jul 6, 2016

LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrill…

FDA Devices Moderate Jun 22, 2016

LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and vers…

FDA Devices Moderate Jun 4, 2014

LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.

FDA Devices Moderate Jul 31, 2013

The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorith…

FDA Devices Moderate Apr 17, 2013

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automat…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.