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Physio-Control, Inc.

62 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 995 recall (Z-2065-2026)Physio-Control, Inc.2026-05-04
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101 recall (Z-1544-2026)Physio-Control, Inc.2026-03-10
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 88387387169 recall (Z-2497-2025)Physio-Control, Inc.2025-09-02
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698 recall (Z-2498-2025)Physio-Control, Inc.2025-09-02
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 L recall (Z-2499-2025)Physio-Control, Inc.2025-09-02
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonar recall (Z-1232-2025)Physio-Control, Inc.2025-02-25
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult recall (Z-1184-2025)Physio-Control, Inc.2025-02-19
LIFEPAK 35 ECG cable REF 11111-000041 recall (Z-1102-2025)Physio-Control, Inc.2025-02-05
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99 recall (Z-0230-2025)Physio-Control, Inc.2024-10-25
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION recall (Z-0142-2025)Physio-Control, Inc.2024-10-22
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 recall (Z-0567-2024)Physio-Control, Inc.2023-12-15
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 recall (Z-0296-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 recall (Z-0297-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 recall (Z-0298-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 recall (Z-0299-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 recall (Z-0300-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 recall (Z-0301-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 recall (Z-0302-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 recall (Z-0303-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 recall (Z-0304-2024)Physio-Control, Inc.2023-11-14
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 recall (Z-0305-2024)Physio-Control, Inc.2023-11-14
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 30 recall (Z-1633-2020)Physio-Control, Inc.2020-04-01
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (L recall (Z-0862-2019)Physio-Control Inc2019-02-26
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/def recall (Z-0863-2019)Physio-Control Inc2019-02-26
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/mo recall (Z-0294-2018)Physio-Control, Inc.2018-01-11
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibri recall (Z-0186-2018)Physio-Control, Inc.2017-12-12
LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrilla recall (Z-0187-2018)Physio-Control, Inc.2017-12-12
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a ph recall (Z-1257-2017)Physio-Control, Inc.2017-03-03
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and the recall (Z-1123-2017)Physio-Control, Inc.2017-02-11
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers recall (Z-1993-2016)Physio-Control, Inc.2016-06-15
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) i recall (Z-1660-2014)Physio-Control, Inc.2014-05-23
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that us recall (Z-1773-2013)Physio Control, Inc.2013-07-19
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xx recall (Z-1082-2013)Physio Control, Inc.2013-04-10
The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery recall (Z-0185-2012)Physio Control, Inc.2011-11-16
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that us recall (Z-2885-2011)Physio Control, Inc.2011-07-26
12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with L recall (Z-2625-2011)Physio Control, Inc.2011-06-22
The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3 recall (Z-1722-2011)Physio Control, Inc.2011-03-18
The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AE recall (Z-1548-2011)Physio Control, Inc.2011-03-04
External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFE recall (Z-2311-2010)Physio Control, Inc.2010-08-28
Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/2 recall (Z-2312-2010)Physio Control, Inc.2010-08-28
LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487 recall (Z-1903-2010)Physio Control, Inc.2010-07-01
Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division recall (Z-1410-2010)Physio Control, Inc.2010-04-21
Biphasic LIFEPAK 12 defibrillator / monitor. recall (Z-0811-2010)Physio Control, Inc.2010-02-22
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor wi recall (Z-2110-2009)Physio Control, Inc.2009-09-18
Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibri recall (Z-2030-2009)Physio Control, Inc.2009-09-14
Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use w recall (Z-1171-2009)Physio Control, Inc.2009-04-07
LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFE recall (Z-0149-2009)Physio Control, Inc.2008-10-30
LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFE recall (Z-0150-2009)Physio Control, Inc.2008-10-30
Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain recall (Z-2388-2008)Physio Control, Inc.2008-09-21
LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be ope recall (Z-1656-2008)Physio Control, Inc.2008-09-16
Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certai recall (Z-1904-2008)Physio Control, Inc.2008-09-16
Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of certai recall (Z-1905-2008)Physio Control, Inc.2008-09-16
Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated recall (Z-1906-2008)Physio Control, Inc.2008-09-16
Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and recall (Z-2035-2008)Physio Control, Inc.2008-09-16
Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024. recall (Z-2036-2008)Physio Control, Inc.2008-09-16
LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public A recall (Z-2341-2008)Physio Control, Inc.2008-09-16
Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor serie recall (Z-1858-2008)Physio Control, Inc.2008-09-11
Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator recall (Z-2009-2008)Physio Control, Inc.2008-09-08
Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillato recall (Z-2010-2008)Physio Control, Inc.2008-09-08
Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator. recall (Z-2011-2008)Physio Control, Inc.2008-09-08
FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redm recall (Z-1567-2008)Physio Control, Inc.2008-08-24
Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with ba recall (Z-1050-2008)Physio Control, Inc.2008-03-29

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Every clearance here is in the API, with alerts when new ones post.