Skip to content
Lower risk Medical device recall · FDA · Published January 14, 2021

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is

Physio-Control

🇺🇸 FDA recall #Z-1189-2021Medical devicePhysio-Control ›
Take action

Contact the company

Recalling firmPhysio-Control, Inc.11811 Willows Rd Ne · Redmond, WA 98052-2003
✎ GovInfoNow plain-language explainer

Physio-Control Read more at govinfonow.com/recall/63424-physio-control.

Source Summary by GovInfoNow · govinfonow.com/recall/63424-physio-control · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1189-2021

Cite this page

“PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/63424-physio-control. Based on FDA recall #Z-1189-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2021%22&limit=1).

The U.S. Food and Drug Administration (FDA) has classified a voluntary recall initiated by Physio-Control, Inc. as Class II.

How to tell if you have it

  • Physio-Control, Inc.
  • Class II
  • Voluntary: Firm initiated

The hazard

The provided facts do not describe the specific hazard associated with this particular recall; they only list hazards from other recent recalls by Physio-Control, Inc. and similar products.

Context

Physio-Control, Inc. has 17 other recalls on record since 2017-10-27. Recent recalls by Physio-Control, Inc. include issues with LIFEPAK 15 Defibrillators serviced between July 2023 through November 2025, Infant/Child Defibrillator Electrodes, and LIFEPAK 1000 Defibrillator inspections.

How to tell if you have this one

Check for the product's model number and serial number on the device itself or in the documentation.

  • Brand
    Physio-Control
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. 1

    Identify the specific model of the Physio-Control device you have.

  2. 2

    Check the device's model number and serial number, which are typically found on a label on the device or in the user manual.

  3. 3

    Ensure that the device is being used in a medical setting with proper training and supervision.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jan 14, 202112. FDA classified it Class II: Mar 9, 202123. Published in FDA’s Enforcement Report: Mar 17, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is Physio-Control a safe brand?

Yes, Physio-Control is a reputable manufacturer of medical devices and is known for producing safe and effective products for use in medical settings.

What types of products does Physio-Control make?

Physio-Control makes a variety of medical devices, including defibrillators, cardiac monitors, and other critical care equipment.

Similar recalls

Latest medical device recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1189-2021 (January 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1189-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA