OneStep CPR Complete — Class II medical device recall Z-0977-2018
Terminated recall by ZOLL Medical Corporation, reported 2018-03-21, distributed nationwide. A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pe
| Recall number | Z-0977-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZOLL Medical Corporation, Chelmsford, MA, United States |
| Recall initiated | 2017-08-04 |
| Classified | 2018-03-13 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,400 |
| UPC / GTIN / UDI-DI | 00847946016272, 10847946016279 |
| Lot numbers | 2517A |
| Model numbers | 0214, 8900 |
| Expiration dates | 2019-06-24 |
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.
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-0977-2018. 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.