The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1091-2022·Announced 2022-05-25

ATLAS Stim Headbox Recalled: Unapproved Investigational Device Without Safety Testing

Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for an unapproved investigational device that lacks electrical safety testing and regulatory clearance. No injuries or deaths have been reported, but the hazard of electrical safety defects in a neurophysiology device presents a risk of harm to users.

Plain-English summary

Neuralynx Inc is recalling the ATLAS Stim Headbox, a component of the ATLAS Neurophysiology System intended for research use only under investigational protocols. Approximately 15 units were distributed nationwide to research institutions in Alabama, California, Illinois, Minnesota, North Carolina, and Rhode Island.

The FDA has classified this as a Class II recall. The device was distributed with the representation that it had an Investigational Device Exemption (IDE) from the FDA, but the manufacturer does not have an approved IDE. The device has not undergone electrical safety testing and has not received regulatory clearance.

Researchers and institutions currently using the ATLAS Stim Headbox should cease use and contact Neuralynx Inc for instructions on return or proper disposal. Healthcare facilities and research institutions should verify whether they have received any of these devices and take appropriate action.

The recalled product

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.
Manufacturer
Neuralynx Inc
Category
Medical Device — Neurophysiology
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • ASHB Part No. 31-0601-0077 (SN0001
  • SN0002
  • SN0004
  • SN0005
  • SN0006
  • SN0007
  • SN0008
  • SN0009
  • SN0010
  • SN0012)
  • ASHB Part No. 31-0601-0132(SN0003
  • SN0006)
  • ASHB Part No. 31-0601-0089(SN0004

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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