Recall Z-0328-2025— Hologic, Inc

Name: FDA recall Z-0328-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-10

Class I · Ongoing

Class I FDA medical device recall by Hologic, Inc, initiated 2024-10-10. It names 2 FDA 510(k) clearances: K152070, K143484. Product: BioZorb Marker. Radiographic soft tissue marker.. Reason: Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort..

Recalling firm: Hologic, Inc
Classification: Class I
Status: Ongoing
Initiated: 2024-10-10
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K152070 — BioZorb LP MarkerFocal Therapeutics·cleared 2015-08-26
K143484 — BioZorb MarkerFocal Therapeutics·cleared 2015-06-29

K-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

BioZorb Marker. Radiographic soft tissue marker.

Reason for recall

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

Data sourced from openFDA. This site is unofficial and independent of the FDA.