Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 Recalled by Devicor Medical Products Inc Due to A 10 Gauge needle, 9cm long was shipped...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Devicor Medical Products Inc directly.
Affected Products
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.
Quantity: F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360
Why Was This Recalled?
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Where Was This Sold?
This product was distributed to 26 states: AL, AR, CA, CT, FL, GA, IL, KS, KY, LA, ME, MD, MA, MI, MN, MS, NJ, NY, NC, OH, PA, SC, TN, WA, WI, DC
About Devicor Medical Products Inc
Devicor Medical Products Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report