Skip to the content

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and…

Medical device recall Z-1189-2021. Published in FDA’s Enforcement Report on Mar 17, 2021.

FDA’s own record

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Mar 17, 2021. Copied from openFDA on Oct 20, 2026.

Class II FDA’s class
Ongoing its status, in FDA’s file
Nationwide FDA’s word, and 53 states named
89,763 units how much, in FDA’s words

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

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

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

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.

89,763 units, in FDA’s words.

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

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:…

Every code shown here, 2,000 characters

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 48598011 48597817 48598026 48598034 48598979 48599034 48599040 48599680 48599962 48600312 48600361 48600408 48600544 48600583 48876291 48785897 48720332 48764293 48780563 48781761 48785992 48742916 48784366 48814157 49086935 48523377 48857980 49085692 48734881 48782906 48809106 48809544 48813958 48814187 48814498 48587878 48512628 48779955 48808967 49094200 48719896 48734817 48745596 48772744 48809729 48813731 48813733 48814081 48814519 49094775 49149468 49150775 49150782 49150837 49151602 49151617 49151886 49152891 49152895 48785250 48785409 48785698 48785778 48864860 48865894 48933501 48992026 49027943 49044403 49044413 48699923 48599821 48722047 48821008 48824104 48864884 48876330 48981618 48982708 49025280 49146285 49146389 48704591 48828002 48781767 48782803 48783051 48783294 48783983 48784030 48784180 48784281 48784459 48784468 48784826 48784905 48784983 48784990 48785257 48785313 48785401 48785532 48785590 48876124 48876476 48785259 48887309 48977361 48978607 48828370 48894333 48894340 48782927 49091822 49094089 49094113 49094785 49094873 49095322 49001621 48769222 48885664…

FDA’s list runs to 887,353 characters. The first part is shown; the rest is on FDA’s record.

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

Worldwide Distribution to U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI , SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV and WY O.U.S. countries of: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Qatar, Saint Barth¿lemy, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

The states and territories these words name

53 states and territories.

Every one of them

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

The firm began the recall on Jan 14, 2021.
FDA classified it on Mar 9, 2021.
FDA’s Enforcement Report published it on Mar 17, 2021.

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

Physio-Control, Inc., of Redmond, WA.
Who began it, in FDA’s words: Voluntary: Firm initiated.
How the firm first told its customers: Letter.

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
Whether anyone was hurt or fell ill: the report doesn’t say.
How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
FDA’s list of codes runs to 887,353 characters; the first part is shown here, and the rest is on FDA’s record.
A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

U.S. Food and Drug Administration, Device recall enforcement reports.

Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

This record in openFDA

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.