FDAFebruary 28, 2017device
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
devicor medical productsdevicordevicor medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCResistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym2026-05-21
- FDAFarm Rich Pizza Cheese Crunchers2026-05-19
- FDAPhilips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Elev...2026-05-18
- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDALegacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags2026-05-18
- FDAPhilips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # ...2026-05-18
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