Affirm Lateral Arm Upright Biopsy Accessory. Product… recallZ-0351-2018 · Hologic, Inc. · initiated Jul 7, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component change control
What the company is doing
Letter
Recall details
- Recall number
- Z-0351-2018
- Status
- Terminated
- Initiated by the company
- Jul 7, 2017
- Recalling firm
- Hologic, Inc.
- Quantity
- 12 (U.S.)
- Product code
- OIJ
- FDA submissions
- K161575
- Distribution
- US and OUS
Product description
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Code information (models, lots, serial numbers)
UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Affirm Lateral Arm Upright Biopsy Accessory ASY-03723Hologic, Inc. · System, x-ray, mammographic1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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