FDA Medical Device Recalls (openFDA)
Devicor Medical Products Inc: 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.
- Recall number
- Z-2211-2016
- Recalling firm
- Devicor Medical Products Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-05-19
- Posted
- 2016-07-14
- Terminated
- 2017-08-03
- Reason
- A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
- Root cause
- Packaging
- Action
- An Urgent: Medical Device Recall of Mammotome Revolve Dual Vacuum Assist Biopsy Probe due to Potential Product Code Mislabel communication was sent to the customers via 1st class USPS on June 6, 2016. The labeling and the Customer response form was also attached. Customers were asked to examine their inventory and quarantine the affected product. If the product was further distributed, those customers are to be identified and notified. The letter stated that the assigned sales rep would be in contact to support the identification, inspection and replacement of the recalled products. Customers are to complete and return the enclosed response form. Questions are to be directed to Mammatome Customer Service 1-877-926-2666.
- Quantity
- F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360
- Distribution
- Worldwide Distribution -- USA, including the states of 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 and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.
- Lot, serial or model codes
- MST1009 - Lot F11537107D1 Exp. Date 9-Sept, 2018; MST0815 Lot F11536423D1 Exp. Date 8-Sept, 2018; and, MST1009 Lot F11537109D1 Exp. Date 10-Sept, 2018.
- 510(k) numbers
- ["K123259"]
- PMA numbers
- not on file
- Product code
- OIJ
- Firm FEI
- 3008492462
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28