Drug & Device Safety Atlas

FDA recall record · openFDA

Physio-Control, Inc.

21 FDA recalls on record (2023–2026) — 21 device. 21 still ongoing.

0
Class I (most serious)
21
Class II
0
Class III
21
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. 10
Due to required inspections not being performed on products/units that have gone through servicing. 3
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Per 1
Due to pediatric defibrillator electrode delamination 1
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator t 1

Recalls

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577 Class II 2026-04-13 PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 0072190 Class II 2026-01-21 LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C Class II 2025-07-22 LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000 Class II 2025-07-22 LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000 Class II 2025-07-22 LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 119 Class II 2025-01-21 LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest. Class II 2025-02-03 LIFEPAK 35 ECG cable REF 11111-000041 Class II 2025-01-21 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril Class II 2024-08-09 LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 Class II 2024-08-30 LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 Class II 2023-09-29 LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 Class II 2023-09-29 LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 Class II 2023-09-29 LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 Class II 2023-09-29 AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 Class II 2023-11-06 LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 Class II 2023-09-29 LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 Class II 2023-09-29 LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 Class II 2023-09-29 LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 Class II 2023-09-29 LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 Class II 2023-09-29 LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 Class II 2023-09-29

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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