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Use caution Medical device recall · FDA · Published April 13, 2026

Physio-Control LIFEPAK 15 Defibrillators May Not Work Properly After Service

Physio-Control recalls LIFEPAK 15 and other defibrillators serviced between July 2023 and November 2025 that may not function correctly due to missing performance inspections. Affected units require verification of service records.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2065-2026Medical devicePhysio-Control ›
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Contact the company

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

Physio-Control is recalling certain LIFEPAK 15, LIFEPAK 1000, LIFEPAK 35, and LIFEPAK 20e defibrillators that were serviced between July 2023 and November 2025 without proper performance inspections. This could cause delays or inability to provide life-saving therapy during emergencies. Read more at govinfonow.com/recall/49486-physio-control-lifepak-15-defibrillators-may-not-work-properly-after.

Source Summary by GovInfoNow · govinfonow.com/recall/49486-physio-control-lifepak-15-defibrillators-may-not-work-properly-after · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2065-2026

Cite this page

“Physio-Control LIFEPAK 15 Defibrillators May Not Work Properly After Service.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49486-physio-control-lifepak-15-defibrillators-may-not-work-properly-after. Based on FDA recall #Z-2065-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2065-2026%22&limit=1).

Physio-Control, Inc. recalled LIFEPAK 15 defibrillators serviced between July 2023 and November 2025 due to potential inability to perform intended use, the FDA said on April 13, 2026. The agency announced the Class II recall after finding some units were serviced without objective evidence of required Performance Inspection Procedures.

How to tell if you have it

  • Physio-Control LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219
  • Physio-Control LIFEPAK 15, REF: 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045
  • Physio-Control LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096
  • Physio-Control LIFEPAK 35, REF: 99335-000013, 99335-000031
  • Physio-Control LIFEPAK 20e, REF: 99507-000122

The hazard

Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted. The inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.

Context

GovInfoNow's records show Physio-Control, Inc. has 17 other recalls on record since 2017-10-27. Other recent recalls of similar products include Physio-Control Infant/Child Defibrillator Electrodes Recall (2026-01-21), Physio-Control LIFEPAK 15 Defibrillator Recall (2025-07-22), and Physio-Control LIFEPAK 20e AED Mode Only for Cardiopulmonary Arrest (2025-02-03). Other recent recalls of similar products include Philips Allura Xper FD10C Medical System Recall (2025-12-15).

How to tell if you have this one

Check for the model name (LIFEPAK 15, LIFEPAK 1000, LIFEPAK 35, or LIFEPAK 20e) and the specific reference numbers listed in the recall notice. Units serviced between July 2023 and November 2025 are affected.

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

What to do — step by step

  1. Check Service Records

    Verify if the device was serviced between July 2023 and November 2025 without a Performance Inspection Procedure (PIP) conducted.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 20 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Colorado, Florida, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 30 days after the firm started it.

1. Firm started the recall: Apr 13, 202612. FDA classified it Class II: May 4, 202623. Published in FDA’s Enforcement Report: May 13, 202632026
  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.

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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-2065-2026 (April 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2065-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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