Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 Recalled by Hologic, Inc. Due to The firm is implementing a product correction involving...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc. directly.
Affected Products
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Quantity: 12 (U.S.)
Why Was This Recalled?
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.
Where Was This Sold?
US and OUS
About Hologic, Inc.
Hologic, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report