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U.S. Department of Health and Human Services

Class 2 Device Recall Hummingbird

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 Class 2 Device Recall Hummingbirdsee related information
Date Initiated by FirmMay 19, 2025
Date PostedJuly 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2100-2025
Recall Event ID 96956
Product Classification Stimulator, nerve - Product Code ETN
ProductBrand 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
Code Information REF I-D-BMF90 & 1-D-BMF90-5, lot number: 050925219
FEI Number 1930870
Recalling Firm/
Manufacturer		 Neurovision Medical Products Inc
353 San Jon Rd
Ventura CA 93001-3250
For Additional Information ContactChristie Vergely
805-2582038
Manufacturer Reason
for Recall		Product packaging contains the wrong part number and kit contents.
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce10
DistributionUS distribution to CA only
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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