Food, drugs, devices › Hologic, Inc
Device recall: Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Hologic, Inc (Marlborough, MA) initiated this device recall on 22 Aug 2016; FDA lists 1 product record under event 74989, classified Class II.
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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 3 Feb 2017. Initiation: voluntary: firm initiated. Hologic, Inc has 41 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
Hologic, Inc, Marlborough, MA.
Reason for recall
"Incorrect label on the Sertera Biopsy Kit"
Distribution
"Nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2869-2016 | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. | 570 units | Class II | Terminated | 28 Sep 2016 |
Context
Other enforcement events for Hologic, Inc
All 41 events for Hologic, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Incorrect label on the Sertera Biopsy Kit"
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: "Nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Feb 2017. "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.