medical Class II Updated 2023-07-05

Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneo

Recalled Product

Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14


Hazard / Issue

The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 15420045504066 Lot Number: E22H19RM
View official government recall

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