Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used… — Class II medical device recall Z-1512-2017
Terminated recall by Devicor Medical Products Inc, reported 2017-03-29, distributed in IA, IL, NY, OH, OK, PA, TN, WV. The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the p
| Recall number | Z-1512-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Devicor Medical Products Inc, Cincinnati, OH, United States |
| Recall initiated | 2017-02-28 |
| Classified | 2017-03-21 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-08-03 |
| Distributed | IA, IL, NY, OH, OK, PA, TN, WV |
| Countries outside the US | BR, CL |
| Quantity | 320 |
| Reason classes | labeling |
Product
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Reason for recall
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
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-1512-2017. 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.