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i-view video laryngoscope. Model Number: 8008000 recallZ-2102-2025 · Intersurgical Inc · initiated Jun 17, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Intersurgical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for faulty devices as a result of depleted batteries.

FDA root cause category: Component design/selection

What the company is doing

Intersurgical 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.

Recall details

Recall number
Z-2102-2025
Status
Open, Classified
Initiated by the company
Jun 17, 2025
Posted by the FDA
Jul 11, 2025
Recalling firm
Intersurgical Inc
Quantity
2,152 pieces
Product code
CCW
Distribution
US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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