FDA Device recall Z-1189-2021

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
ongoing
Published 2021-03-17

On 2021-03-17 the FDA classified a Class II recall of PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary e… by Physio Control, citing due to complaints received regarding missing lid magnets which may result in premature battery depletion.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1189-2021
Classification	Class II
Status	ongoing
Initiated	2021-01-14
Published	2021-03-17
Last updated	2026-09-13 11:56 UTC
Company	Physio Control
Distribution	US

Product

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.

Reason

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

Identifiers

code_info	Model Number 3321605-xxx, U.S. Device Part Numbers with Conforming Lids: CR2-2-001281, CR2-2-001279, CR2-2-001285… Model Number 3321605-xxx, U.S. Device Part Numbers with Conforming Lids: CR2-2-001281, CR2-2-001279, CR2-2-001285, CR2-2-001278, CR2-2-001283, CR2-2-001280, CR2-2-001451, CR2-2-001452, CR2-2-000396, CR2-2-001457, Device Serial Numbers: 48603094 48784877 49025132 49091799 48741587 49077058 48764540 48764590 48601446 48603907 48609453 48652129 48652251 48858056 48981644 48722045 48726027 48726129 48726140 48726150 48693695 48694311 48698571 48698584 48952116 48953086 48554965 48817780 48825290 48849399 48899908 48899994 48900065 48900096 48901342 48901357 48901414 48901451 48902351 48977818 48978218 48981319 48981675 48981678 48981736 48981742 48981757 48981799 48982659 48982689 48982706 48982732 48982753 48982964 48983131 48983138 48986526 48999915 49001794 48677566 49000689 48474854 48825196 48744684 49025723 49078040 49084781 49084838 48784171 49076651 49077904 49077974 48999739 49001853 4859801

code_info

Model Number 3321605-xxx, U.S. Device Part Numbers with Conforming Lids: CR2-2-001281, CR2-2-001279, CR2-2-001285…

Model Number 3321605-xxx, U.S. Device Part Numbers with Conforming Lids: CR2-2-001281, CR2-2-001279, CR2-2-001285, CR2-2-001278, CR2-2-001283, CR2-2-001280, CR2-2-001451, CR2-2-001452, CR2-2-000396, CR2-2-001457, Device Serial Numbers: 48603094 48784877 49025132 49091799 48741587 49077058 48764540 48764590 48601446 48603907 48609453 48652129 48652251 48858056 48981644 48722045 48726027 48726129 48726140 48726150 48693695 48694311 48698571 48698584 48952116 48953086 48554965 48817780 48825290 48849399 48899908 48899994 48900065 48900096 48901342 48901357 48901414 48901451 48902351 48977818 48978218 48981319 48981675 48981678 48981736 48981742 48981757 48981799 48982659 48982689 48982706 48982732 48982753 48982964 48983131 48983138 48986526 48999915 49001794 48677566 49000689 48474854 48825196 48744684 49025723 49078040 49084781 49084838 48784171 49076651 49077904 49077974 48999739 49001853 4859801

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.