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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.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Physio-Control Internal Defibrillation Paddles Recalled for Cracking Risk

Agency Publication Date: October 22, 2024
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Summary

Physio-Control, Inc. is recalling 3,617 Sterilizable Internal Defibrillation Paddles (Models LP20 and LP15) due to product failures including cracks and separation of the outer molding. The company has received customer complaints and reports of these failures appearing straight out of the box. These paddles are clinical medical devices used to deliver life-saving electrical shocks to patients suffering from fatal heart rhythm disturbances. If you use these paddles in a clinical setting, stop using the affected units and contact the manufacturer to arrange for a return, replacement, or repair.

Risk

Cracks or separation in the paddle components can lead to device failure during use. This may prevent a clinician from delivering necessary electrical shocks during a cardiac emergency, which could lead to patient injury or death. Out-of-box failures and customer complaints have already been reported.

What You Should Do

  1. This recall affects Physio-Control Sterilizable Internal Defibrillation Paddles, models LP20 and LP15, sold under various part and catalog numbers. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately to ensure it is not used during a patient emergency.
  3. Contact Physio-Control, Inc. or your authorized medical distributor to arrange for a return, replacement, or correction of the paddles.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information or visit www.fda.gov/medical-devices/medical-device-recalls.

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: Sterilizable Internal Defibrillation Paddles LP20
Model / REF:
11131-000040
11131-000041
11131-000042
11131-000043
3317813-001
3317813-005
3317813-002
3317813-006
3317813-003
3317813-007
3317813-004
Serial Numbers:
101648901
86557878
87141562
88458193
88482392
93989670
107741863
86287034
86949592
90445090
91624045
93441890
107556559
100198569
100759224
101002312
101042672
101383090
84830138
84881382
84915416
86240215
86260453
86949593
87794908
90445091
91380577
92185462
96496375
96496376
96496377
97059498
105817428
106332158
107556560
101506304
86949594
90445092
UDI:
00883873863558
00883873863534
00883873863527
00883873863510
Product: Sterilizable Internal Defibrillation Paddles LP15
Model / REF:
11131-000044
11131-000045
11131-000046
11131-000047
3317814-001
3317814-005
3317814-003
3317814-007
3317814-004
3317814-008
3317814-002
3317814-006
Serial Numbers:
90445093
93441892
98719352
98719353
99649024
99649025
107124577
101888461
101888462
101888463
102107169
103669336
103669337
104125087
104129892
104440600
86280420
90445095
92556517
92871913
95836040
97111384
98719364
98719365
98813631
99692098
106555464
106721716
106917875
106968460
107445069
107741891
90445096
98719376
98813643
98990261
99692108
107124605
84830141
90445094
91515844
92556516
92871911
93441893
98719358
98719359
99692092
107078533
107445059
UDI:
00883873863503
00883873863497
00883873863480
00883873863213

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95242
Status: Active
Manufacturer: Physio-Control, Inc.
Sold By: Physio-Control authorized medical distributors; Direct hospital supply channels
Manufactured In: United States
Units Affected: 3,617 devices (US-3315 and O.U.S - 302 devices)
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, 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.