Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Monitoring Devices

Physio-Control LIFEPAK 15 Monitor/Defibrillators Recalled for Tooling Inaccuracy

Agency Publication Date: October 25, 2024
Share:
Sign in to monitor this recall

Summary

Physio-Control, Inc. is recalling 105 LIFEPAK 15 (LP15) Monitor/Defibrillators because an out-of-tolerance tool was used during their production. These devices are used in medical and emergency settings to monitor patient heart activity and provide life-saving shocks during cardiac arrest. No injuries or incidents have been reported in connection with this manufacturing issue.

Risk

The use of an inaccurate tool during manufacturing could affect the device's accuracy or performance, potentially leading to errors in patient monitoring or the delivery of critical therapy during a medical emergency.

What You Should Do

  1. This recall affects Physio-Control LIFEPAK 15 (LP15) Monitor/Defibrillators with specific model numbers, UDI-DI codes, and serial numbers. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately.
  3. Contact Physio-Control, Inc. or your authorized medical distributor to arrange for the return, replacement, or correction of the equipment.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for more information about this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: LIFEPAK 15 (LP15) Monitor/Defibrillator
Model / REF:
97577-000101
99577-000046
99577-000055
99577-000061
99577-000076
99577-001250
99577-001255
99577-001256
99577-001368
99577-001955
99577-001956
99577-001957
99577-001958
99577-001962
Serial Numbers (102):
45435833
46470647
46686048
46686573
46686708
46687360
46906073
49037777
49704552
38166647
38282988
38290136
38291331
38802782
39541663
39541666
39752193
40259639
41446867
41447020
41453331
42325059
43574409
43984215
45040678
45308104
45455023
46017745
46572054
46576300
48349664
48605645
48605663
49001744
49025185
49070762
49087040
49087053
49224619
49374174
49422314
49619921
38200440
38805564
38805583
39382735
41446693
41446882
41446975
41446977
UDI:
00883873808214
00883873988022
00883873979426
00883873979358
00883873911693
00883873979198
00883873911648
00883873884386
00883873871713
00883873871706
00883873871690
00883873871683
00883873911631
00883873871645

LIFEPAK 15 intended use monitor/defibrillator.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95373
Status: Active
Manufacturer: Physio-Control, Inc.
Sold By: Authorized Medical Distributors; Physio-Control, Inc.
Manufactured In: United States
Units Affected: 105 systems
Distributed To: Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.