# FDA recall Z-0351-2018

> **Hologic, Inc.** · Class II · device recall initiated 2017-07-07.

## 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.

## Distribution

US and OUS

## Key facts

- **Recall number:** Z-0351-2018
- **Recalling firm:** Hologic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-07
- **Report date:** 2018-01-24
- **Termination date:** 2018-04-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danbury, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0351-2018

## Citation

> AI Analytics. FDA recall Z-0351-2018. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0351-2018. Source: US FDA. Licensed CC0.

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