Affirm Lateral Arm Upright Biopsy Accessory — Class II medical device recall Z-0351-2018
Terminated recall by Hologic, Inc., reported 2018-01-24. The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-
| Recall number | Z-0351-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Danbury, CT, United States |
| Recall initiated | 2017-07-07 |
| Classified | 2018-01-14 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2018-04-04 |
| Quantity | 12 |
| UPC / GTIN / UDI-DI | 15420045506817 |
| Serial numbers | LAT1200100, LAT1200165 |
Product
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0351-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.