Coolife Sinergy Radiofrequency Kit — Class II medical device recall Z-2391-2016
Terminated recall by Halyard Health, Inc, reported 2016-08-17, distributed in CT, IL, MA, MI, NC, NH, NV, TX. Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
| Recall number | Z-2391-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Halyard Health, Inc, Alpharetta, GA, United States |
| Recall initiated | 2016-06-16 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-09-08 |
| Distributed | CT, IL, MA, MI, NC, NH, NV, TX |
| Countries outside the US | CA |
| Quantity | 51 kits |
| Lot numbers | M5264D205 |
Product
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Reason for recall
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
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-2391-2016. 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.