# FDA recall Z-1091-2022

> **Neuralynx Inc** · Class II · device recall initiated 2022-03-14.

## Product

ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.

## Reason for recall

Atlas Stim Headbox (ASHB) was delivered to US customers  under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer  does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.

## Distribution

U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.

## Key facts

- **Recall number:** Z-1091-2022
- **Recalling firm:** Neuralynx Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-14
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bozeman, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1091-2022

## Citation

> AI Analytics. FDA recall Z-1091-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1091-2022. Source: US FDA. Licensed CC0.

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