ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology… — Class II medical device recall Z-1091-2022
Ongoing recall by Neuralynx Inc, reported 2022-05-25, distributed nationwide. Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational
| Recall number | Z-1091-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neuralynx Inc, Bozeman, MT, United States |
| Recall initiated | 2022-03-14 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Model numbers | 31-0601-0077, 31-0601-0089, 31-0601-0132 |
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.
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-1091-2022. 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.