# FDA recall Z-0142-2025

> **Physio-Control, Inc.** · Class II · device recall initiated 2024-08-09.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0142-2025
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-09
- **Report date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2025

## Citation

> AI Analytics. FDA recall Z-0142-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0142-2025. Source: US FDA. Licensed CC0.

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