Drugs & medicalClass II

Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product…

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

Read the official notice →
Date
2025-02-19
Country
United States
Brand
Hologic
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product…
Classification
Class II
Units
Domestic: Nationwide Distribution
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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