FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
- Recall number
- Z-0351-2018
- Recalling firm
- Hologic, Inc.
- Product
- Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
- Status
- Terminated
- Initiated
- 2017-07-07
- Posted
- not on file
- Terminated
- 2018-04-04
- Reason
- 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.
- Root cause
- Component change control
- Action
- Letter
- Quantity
- 12 (U.S.)
- Distribution
- US and OUS
- Lot, serial or model codes
- UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
- 510(k) numbers
- ["K161575"]
- PMA numbers
- not on file
- Product code
- OIJ
- Firm FEI
- 1220984
- Firm city
- Danbury
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28