Neuralynx Inc: Medical Device Recall in 2022 - (Recall #: Z-1091-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 14, 2022

Date Posted: May 25, 2022

Recall Number: Z-1091-2022

Event ID: 89843

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.

Status: Ongoing

Product Quantity: 15

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated