Nalu Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2257-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.

Product Classification:

Class II

Date Initiated: June 3, 2024

Date Posted: July 10, 2024

Recall Number: Z-2257-2024

Event ID: 94682

Reason for Recall:

Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.

Status: Ongoing

Product Quantity: 13

Code Information:

UDI-DI: 71005-US: 00812537036137, 00812537033600, 00812537033518, 00812537030975, 00812537030524. 71019-US: 00812537036441, 00812537035604, 00812537035598 Serial Numbers: H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431

Distribution Pattern:

US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.

Voluntary or Mandated:

Voluntary: Firm initiated