Recall Z-1170-2025— Hologic, Inc
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc, initiated 2025-01-15. It names one FDA 510(k) clearance: K150169. Product: Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A. Reason: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement..
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-15
- Firm location
- Marlborough, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Reason for recall
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Data sourced from openFDA. This site is unofficial and independent of the FDA.