FDA recall Z-2100-2025

Neurovision Medical Products Inc · Class II · device

Product

Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle

Reason for recall

Product packaging contains the wrong part number and kit contents.

Distribution

US distribution to CA only

Key facts

Status
Ongoing
Initiation date
2025-05-19
Report date
2025-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ventura, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2100-2025