Devicor Medical Products

4 recalls •

• Categories: Other Medical Devices, Diagnostic Equipment, Implants & Prosthetics

HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

Class I - Dangerous

Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.

Mar 30, 2022 Other Medical Devices Nationwide View Details →

Neoprobe GDS Control Unit, Model Number NPCU3

Class I - Dangerous

It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.

Sep 7, 2020 Other Medical Devices View Details →

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

Class I - Dangerous

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.

Feb 28, 2017 Diagnostic Equipment View Details →

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.

Class I - Dangerous

A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

May 19, 2016 Implants & Prosthetics Nationwide View Details →