# FDA recall Z-1502-2022

> **Neotract  Inc** · Class II · device recall initiated 2022-06-24.

## Product

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

## Reason for recall

There is the potential that during implant deployment, the device may not properly deliver a  implant.

## Distribution

US: AK	AL	AR	AZ	CA	CO	CT	DC	DE	FL	GA	IA	IL	IN	KS	KY	LA	MA	MD	ME	MI	MN	MO	MS	MT	NC	ND	NE	NH	NJ	NM	NY	OH	OK	PA	RI	SC	SD	TN	TX	UT	VA	VT	WI	WV  OUS:  None

## Key facts

- **Recall number:** Z-1502-2022
- **Recalling firm:** Neotract  Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-24
- **Report date:** 2022-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2022

## Citation

> AI Analytics. FDA recall Z-1502-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1502-2022. Source: US FDA. Licensed CC0.

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