Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Numb...

FDA Device Recall #Z-2100-2025 — Class II — May 19, 2025

Recall Summary

Recall Number Z-2100-2025
Classification Class II — Moderate risk
Date Initiated May 19, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Neurovision Medical Products Inc
Location Ventura, CA
Product Type Devices
Quantity 10

Product Description

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 Pattern

US distribution to CA only

Lot / Code Information

REF I-D-BMF90 & 1-D-BMF90-5, lot number: 050925219

Other Recalls from Neurovision Medical Products Inc

Recall # Classification Product Date
Z-2719-2024 Class II Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003... Jul 1, 2024
Z-2902-2020 Class II Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch ... Jul 21, 2020
Z-2907-2020 Class II Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DC... Jul 21, 2020
Z-2903-2020 Class II Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S... Jul 21, 2020
Z-2904-2020 Class II Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5... Jul 21, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.