Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Singl

FDA device recall Z-2100-2025 · posted 2025-07-09 · Open, Classified

Recall details

Recalling firm

Neurovision Medical Products Inc

Reason for recall

Product packaging contains the wrong part number and kit contents.

Action taken

On May 20, 2025, Neurovision Medical Products (NMP) sent consignees an email notifying them of the recall. On June 10, 2025, NMP followed up with "Urgent Medical Device Recall Notice" dated May 27, 2025, via US postal mail. Neurovision asked consignees to take the following actions: 1. Review your inventory for affected lots. 2. Quarantine product. 3. Cease distribution and use of any affected product. 4. Pass this notice on to all who need to be aware within your organization and/or to any organization where the potentially affected product has been transferred or distributed. 5. Complete and return the enclosed response form as soon as possible via email: customer_service@neurovisionmedical.com or Fax to: (877) 330-1727. 6. NMP Customer Service will respond with a return authorization (RMA) number and return shipping label for any remaining stock. 7. If you have distributed this product to another location or entity, notify them of this product recall (include a copy of this notice), and contact NMP Customer Service for return authorization (RMA). If you have any questions, contact NMP Customer service at (866) 815-6999. NMP Days/Hours Available: Monday through Friday, 8am-4pm (Pacific) and Website: neurovisionmedical.com

Root cause

Process control

Status

Open, Classified

Product code

ETN

Quantity affected

10

Distribution

US distribution to CA only

Date initiated

2025-05-19

Date posted

2025-07-09

Location

Ventura, CA