STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDL...
FDA Device Recall #Z-0142-2025 — Class II — August 9, 2024
Recall Summary
| Recall Number | Z-0142-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 9, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Physio-Control, Inc. |
| Location | Redmond, WA |
| Product Type | Devices |
| Quantity | 3,617 devices (US-3315 and O.U.S - 302 devices) |
Product Description
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
Reason for Recall
Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and New Zealand.
Lot / Code Information
LP20 Model/Catalog Number: 11131-000040 UDI-DI codes: 00883873863558 Part Number: 3317813-001 Serial Numbers: 101648901 86557878 87141562 88458193 88482392 93989670 Part Number: 3317813-005 Serial Number: 107741863 Model/Catalog Number: 11131-000041 UDI-DI code: 00883873863534 Part Number: 3317813-002 Serial Numbers: 86287034 86949592 90445090 91624045 93441890 Part Number: 3317813-006 Serial Number: 107556559 Model/Catalog Number: 11131-000042 UDI-DI code: 00883873863527 Part Number: 3317813-003 Serial Numbers: 100198569 100759224 101002312 101042672 101383090 84830138 84881382 84915416 86240215 86260453 86557878 86949593 87794908 90445091 91380577 92185462 96496375 96496376 96496377 97059498 Part Number: 3317813-007 Serial Numbers: 105817428 106332158 107556560 Model/Catalog Number: 11131-000043 UDI-DI code: 00883873863510 Part Number: 3317813-004 Serial Numbers: 101506304 86949594 90445092 LP15 Model/Catalog Number: 11131-000044 UDI-DI code: 00883873863503 Part Number: 3317814-001 Serial Numbers: 90445093 93441892 98719352 98719353 99649024 99649025 Part Number: 3317814-005 Serial Number: 107124577 Model/Catalog Number: 11131-000045 UDI-DI code: 00883873863497 Part Number: 3317814-003 Serial Numbers: 101888461 101888462 101888463 102107169 103669336 103669337 104125087 104129892 104440600 86280420 90445095 92556517 92871913 95836040 97111384 98719364 98719365 98813631 99692098 Part Number: 3317814-007 Serial Numbers: 106555464 106721716 106917875 106968460 107445069 107741891 Model/Catalog Number: 11131-000046 UDI-DI code: 00883873863480 Part Number: 3317814-004 Serial Numbers: 90445096 98719376 98813643 98990261 99692108 Part Number: 3317814-008 Serial Numbers: 107124605 Model/Catalog Number: 11131-000047 UDI-DI code: 00883873863213 Part Number: 3317814-002 Serial Numbers: 84830141 90445094 91515844 92556516 92871911 93441893 98719358 98719359 99692092 Part Number: 3317814-006 Serial Numbers: 107078533 107445059
Other Recalls from Physio-Control, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1544-2026 | Class II | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defi... | Jan 21, 2026 |
| Z-2499-2025 | Class II | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI co... | Jul 22, 2025 |
| Z-2497-2025 | Class II | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code... | Jul 22, 2025 |
| Z-2498-2025 | Class II | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI co... | Jul 22, 2025 |
| Z-1232-2025 | Class II | LIFEPAK 20e REF 99507-000001 The AED mode is... | Feb 3, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.