# FDA recall Z-0977-2018

> **ZOLL Medical Corporation** · Class II · device recall initiated 2017-08-04.

## Product

OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272)    Product Usage:  Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.

## Reason for recall

A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display  PEDIATRIC PADS IN USE  on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk.

## Distribution

Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and in the countries of Canada.

## Key facts

- **Recall number:** Z-0977-2018
- **Recalling firm:** ZOLL Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-04
- **Report date:** 2018-03-21
- **Termination date:** 2018-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chelmsford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0977-2018

## Citation

> AI Analytics. FDA recall Z-0977-2018. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0977-2018. Source: US FDA. Licensed CC0.

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