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U.S. Department of Health and Human Services

Class 1 Device Recall iview video laryngoscope

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 Class 1 Device Recall iview video laryngoscopesee related information
Date Initiated by FirmJune 17, 2025
Date PostedJuly 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2102-2025
Recall Event ID 97121
Product Classification Laryngoscope, rigid - Product Code CCW
Producti-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Code Information Model Number: 8008000. UDI-DI (Case): 05030267166497. UDI-DI (Single Unit): 5030267150649. Lot Numbers: 1240555, 1240793.
FEI Number 1000120301
Recalling Firm/
Manufacturer		 Intersurgical Inc
5010 Campuswood Dr Ste 102
East Syracuse NY 13057-1561
For Additional Information ContactCustomer Support
800-828-9633
Manufacturer Reason
for Recall		Potential for faulty devices as a result of depleted batteries.
FDA Determined
Cause 2		Component design/selection
ActionIntersurgical notified consignees and account executives via email on 06/17/2025. The notification instructed consignees and account executives to immediately discontinue use and quarantine any affected stock on hand, notify customers if affected units have been further distributed, and contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number and return label to return all affected units. Also, they were instructed to complete and return the Customer Product Recall Acknowledgement Form.
Quantity in Commerce2,152 pieces
DistributionUS distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.
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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