ZOLL Pro-padz Sterile Multi-Function Electrodes — Class II medical device recall Z-0053-2015
Terminated recall by Bio-Detek, Inc., reported 2014-10-15, distributed nationwide. Product sterility is not assured
| Recall number | Z-0053-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Detek, Inc., Pawtucket, RI, United States |
| Recall initiated | 2014-09-16 |
| Classified | 2014-10-08 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2016-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, DE, FR |
| Quantity | 18 singles |
| Reason classes | sterility |
| Lot numbers | 1614, 1814 |
| Model numbers | 8900-4013 |
Product
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
Reason for recall
Product sterility is not assured
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-0053-2015. 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.