Z-2102-2025Class I

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

Name: Z-2102-2025 i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate...
Creator: Intersurgical Inc
Published: 2025-06-17
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2025-06-17 / Open, Classified / root cause: design

FDA source

Intersurgical Inc began a recall of i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy on 2025-06-17. FDA classified it as Class I and gives the reason as "Potential for faulty devices as a result of depleted batteries". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2102-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-06-17
Posted: 2025-07-11
Recalling firm: Intersurgical Ltd.
Product: i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Potential for faulty devices as a result of depleted batteries.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 2,152 pieces
Distribution: US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.
Product codes and lots: Model Number: 8008000. UDI-DI (Case): 05030267166497. UDI-DI (Single Unit): 5030267150649. Lot Numbers: 1240555, 1240793.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2102-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2102-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-11

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)