FDA Device recall Z-0351-2018
Affirm Lateral Arm Upright Biopsy Accessory
- FDA Device
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Affirm Lateral Arm Upright Biopsy Accessory by Hologic, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0351-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-07 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hologic |
| Distribution | n/a |
Product
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
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.
Identifiers
| code_info | UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Hologic
- 3DIMENSIONS MAMMOGRAPHY SYSTEM
FDA Device · Class II · 2026-05-20 · Hologic - SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D…
FDA Device · Class II · 2026-05-20 · Hologic - Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Ve…
FDA Device · Class II · 2026-05-06 · Hologic - Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
FDA Device · Class II · 2026-03-25 · Hologic - Brevera Breast Biopsy System Disposable 9 Gauge Needle
FDA Device · Class II · 2026-02-18 · Hologic
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0351-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.