Mammotome Revolve Dual Vacuum Assist Biopsy System Model number:… — Class II medical device recall Z-2211-2016
Terminated recall by Devicor Medical Products Inc, reported 2016-07-20, distributed in AL, AR, CA, CT, DC, FL, GA, IL…. A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
| Recall number | Z-2211-2016 |
|---|---|
| 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 | 2016-05-19 |
| Classified | 2016-07-14 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-08-03 |
| Distributed | AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA, WI |
| Countries outside the US | CA, JP, KR, NL |
| Lot numbers | F11536423D1, F11537107D1, F11537109D1, MST0815, MST1009 |
| Model numbers | MST0815, MST1009 |
| Expiration dates | 2018-09-08, 2018-09-09, 2018-09-10 |
Product
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
Reason for recall
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
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-2211-2016. 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.