Hologic recalls Sertera-14 biopsy devices due to risk of inner needle separating from hub, potentially causing dislodgement. Affected units include specific model numbers and lot codes.
“Hologic Sertera Biopsy Device Recall: Inner Needle Separation Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53087-hologic-sertera-biopsy-device-recall-inner-needle-separation-risk. Based on FDA recall #Z-1170-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1170-2025%22&limit=1).
The FDA announced on Jan. 15, 2025, that Hologic, Inc. is recalling the Sertera Biopsy Device due to a hazard where the inner needle may separate from the hub. The agency issued recall number Z-1170-2025 for the voluntary Class II action.
According to the FDA, devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Context
GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since June 27, 2017. Other recent recalls include the Hologic SELENIA Dimensions Mammography Systems Recall (April 8, 2026), the Hologic Genius Review Station Display Recall (March 23, 2026), and the Hologic Aptima HPV Assay Kit Recall (Feb. 18, 2026). Other recent recalls of similar products include the Medline Recalls Olympus Biopsy Kits (Feb. 16, 2026), the Olympus Single Use Biopsy Valve Recall (Jan. 29, 2026), and the Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026).
How to tell if you have this one
Check for model number Sertera-14 on the device. Affected units have specific lot numbers listed in the recall notice, including E23B23RL through E23L28RD and others.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for the model number Sertera-14 on the device to confirm if it is affected.
Contact Manufacturer
Reach out to Hologic for guidance on next steps if the device is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1170-2025 (January 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1170-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.