Devicor Medical Products Inc: Medical Device Recall in 2017 - (Recall #: Z-1512-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance

Product Classification:

Class II

Date Initiated: February 28, 2017

Date Posted: March 29, 2017

Recall Number: Z-1512-2017

Event ID: 76603

Reason for Recall:

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.

Status: Terminated

Product Quantity: 320

Code Information:

F11621304D1

Distribution Pattern:

Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil

Voluntary or Mandated:

Voluntary: Firm initiated