Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 cardioversi — recall Z-0142-2025

U.S. FDA — Device Enforcement · United States · 2024-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0142-2025
Date of alert
2024-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Physio-Control, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00883873863558
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.