Z-2100-2025Class II

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

Name: Z-2100-2025 Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF...
Creator: Neurovision Medical Products Inc
Published: 2025-05-19
License: https://open.fda.gov/license/

Neurovision Medical Products Inc / initiated 2025-05-19 / Open, Classified / root cause: manufacturing process

FDA source

Neurovision Medical Products Inc began a recall of Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation... on 2025-05-19. FDA classified it as Class II and gives the reason as "Product packaging contains the wrong part number and kit contents". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2100-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-19
Posted: 2025-07-09
Recalling firm: Neurovision Medical Products Inc
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
Product code: ETN Stimulator, Nerve
Reason for recall: Product packaging contains the wrong part number and kit contents.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected] 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
Quantity in commerce: 10
Distribution: US distribution to CA only
Product codes and lots: REF I-D-BMF90 & 1-D-BMF90-5, lot number: 050925219

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2100-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-09

Product code ETN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)