STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE… — Class II medical device recall Z-0142-2025
Ongoing recall by Physio-Control, Inc., reported 2024-10-30, distributed nationwide. Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of p
| Recall number | Z-0142-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2024-08-09 |
| Classified | 2024-10-22 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NL, NZ |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00883873863213, 00883873863480, 00883873863497, 00883873863503, 00883873863510, 00883873863527, 00883873863534, 00883873863558 |
| Serial numbers | 100198569, 100759224, 101002312, 101042672, 101383090, 101506304, 101648901, 101888461, 101888462, 101888463, 102107169, 103669336, 103669337, 104125087, 104129892, 104440600, 105817428, 106332158, 106555464, 106721716, 106917875, 106968460, 107078533, 107124577, 107124605 and 63 more |
| Model numbers | 11131-000040, 11131-000041, 11131-000042, 11131-000043, 11131-000044, 11131-000045, 11131-000046, 11131-000047, 3317813-001, 3317813-002, 3317813-003, 3317813-004, 3317813-005, 3317813-006, 3317813-007, 3317814-001, 3317814-002, 3317814-003, 3317814-004, 3317814-005, 3317814-006, 3317814-007, 3317814-008, LP15, LP20 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0142-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.