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Recall Observatory FDA recall evidence

Device product

i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

Z-2102-2025

June 17, 2025

Class I

Product summary

Firm
Intersurgical Inc
Event
Event 97121
Status
Ongoing
Classification
Class I
Quantity
2,152 pieces
Official record key
device-enforcement:Z-2102-2025

Official wording

Reason: Potential for faulty devices as a result of depleted batteries.

Code information: Model Number: 8008000. UDI-DI (Case): 05030267166497. UDI-DI (Single Unit): 5030267150649. Lot Numbers: 1240555, 1240793.

Distribution pattern: US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for faulty devices as a result of depleted batteries.