Cardio Medical Products — Class II medical device recall Z-1669-2013
Terminated recall by Cardio Medical Products, reported 2013-07-17, distributed nationwide. Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affec
| Recall number | Z-1669-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardio Medical Products, Rockaway, NJ, United States |
| Recall initiated | 2013-04-26 |
| Classified | 2013-07-08 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2016-08-15 |
| Distributed | Nationwide (US) |
| Quantity | 657 units |
| Lot numbers | Y020613-03, Y111412-2, Y111912-17 |
| Model numbers | O101 |
Product
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
Reason for recall
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
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-1669-2013. 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.