i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngosc
Summary
The FDA issued a Class I for i-view video laryngoscope. Model Number: 8008000. The i-view video laryngosc by Intersurgical Inc. Reason: Potential for faulty devices as a result of depleted batteries..
Details
Source
Device Recall
External ID
Z-2102-2025
Action Date
2025-07-23
Status
Ongoing
Category
device
Product Description
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Lot/Code Info: Model Number: 8008000. UDI-DI (Case): 05030267166497. UDI-DI (Single Unit): 5030267150649. Lot Numbers: 1240555, 1240793.
Quantity Affected: 2,152 pieces
Reason for Recall
Potential for faulty devices as a result of depleted batteries.
Distribution
US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-17
Company
East Syracuse, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 109 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intersurgical Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intersurgical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intersurgical Inc have FDA actions?
Intersurgical Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2102-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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