# FDA recall Z-1544-2026

> **Physio-Control, Inc.** · Class II · device recall initiated 2026-01-21.

## Product

PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes  Catalog Numbers: 11101-000016  UDI-DI code: 00721902629013    Catalog Number: 11101-000017  UDI-DI code: 00721902682483    Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).

## Reason for recall

Due to pediatric defibrillator electrode delamination

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of  Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan.

## Key facts

- **Recall number:** Z-1544-2026
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-21
- **Report date:** 2026-03-18

- **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-1544-2026

## Citation

> AI Analytics. FDA recall Z-1544-2026. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1544-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
