Use cautionMedical device recall · FDA · Published May 2, 2023
Hologic Sertera 14 Gauge Biopsy Device Recall: Risk of Delayed Surgery
Hologic recalls Sertera 14 Gauge Biopsy Devices due to potential needle detachment causing surgery delays. Affected devices have specific lot numbers and UDI-DI codes.
“Hologic Sertera 14 Gauge Biopsy Device Recall: Risk of Delayed Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58479-hologic-sertera-14-gauge-biopsy-device-recall-risk-of-delayed. Based on FDA recall #Z-2035-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2023%22&limit=1).
The FDA announced on May 2, 2023, that Hologic, Inc. is recalling Sertera 14 Gauge Biopsy Devices because the inner needle may detach or discharge, potentially causing delays in surgery. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Hologic
Product: Sertera 14 Gauge Biopsy Device
Reference: SERTERA-14
UDI-DI: 15420045504066
Lot Number: E22H19RM
Quantity: 756 units
The hazard
According to the FDA, the inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery. The recall involves devices intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast.
Context
GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since June 27, 2017. Other recent recalls include the April 8, 2026, recall of Hologic 3D Mammography Systems for loose bolts risk and the March 23, 2026, recall of Hologic Genius Review Station Displays for user modifications risk safety. Similar recent recalls of biopsy products include the February 16, 2026, Medline recall of Olympus Biopsy Kits for foreign body risk and the August 20, 2026, Bard Breast Biopsy System recall for procedure interruptions.
How to tell if you have this one
Check for the model name 'Sertera 14 Gauge Biopsy Device' and lot number E22H19RM. The UDI-DI code 15420:0045504066 identifies affected units.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the lot number and UDI-DI code on the device to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US 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 2 months 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-2035-2023 (May 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2035-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.