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 The device is Recalled by Devicor Medical Products Inc Due to The device did not have Revolve Stereo Probe...
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 The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Quantity: 320
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 8 states: IL, IA, NY, OH, OK, PA, TN, WV
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