FDAJuly 7, 2017device

Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.

What to do

FDA enforcement status: Terminated

Brands named

hologic

UPCs

15420045506817

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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