Devicor Medical Products Inc
Devicor Medical Products Inc has 5 FDA enforcement events on this register (5 product records) between 2016 and 2026: 5 device; the busiest year was 2016 with 1.
0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in OH.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 24 Apr 2026 | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Device | Class II | 1 | Ongoing |
| 30 Mar 2022 | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | Device | Class II | 1 | Terminated |
| 7 Sep 2020 | Neoprobe GDS Control Unit, Model Number NPCU3 | Device | Class III | 1 | Terminated |
| 28 Feb 2017 | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance | Device | Class II | 1 | Terminated |
| 19 May 2016 | 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… | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Devicor Medical Products Inc had?
5 enforcement events (5 product records) on this register, 2016–2026: 5 device.
Are any Devicor Medical Products Inc recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Devicor Medical Products Inc recalls?
4 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.