Food, drugs, devices › Devicor Medical Products Inc
Device recall: HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA enforcement event 90119 is a device recall by Devicor Medical Products Inc of Cincinnati, OH, initiated 30 Mar 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 30 Apr 2024. Initiation: voluntary: firm initiated. Devicor Medical Products Inc has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Devicor Medical Products Inc, Cincinnati, OH.
Reason for recall
"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."
Distribution
"US Nationwide distribution in the states of DE, KY, NY, OH, WV."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1124-2022 | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | 90 devices | Class II | Terminated | 1 Jun 2022 |
Context
Other enforcement events for Devicor Medical Products Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Apr 2026 | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Device | Class II | 1 |
| 7 Sep 2020 | Neoprobe GDS Control Unit, Model Number NPCU3 | Device | Class III | 1 |
| 28 Feb 2017 | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified a | Device | Class II | 1 |
| 19 May 2016 | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged wi | Device | Class II | 1 |
All 5 events for Devicor Medical Products Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of DE, KY, NY, OH, WV."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Apr 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.