FDA Medical Device Recalls (openFDA)
Intersurgical Inc: i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
- Recall number
- Z-2102-2025
- Recalling firm
- Intersurgical Inc
- Product
- i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
- Status
- Open, Classified
- Initiated
- 2025-06-17
- Posted
- 2025-07-11
- Terminated
- not on file
- Reason
- Potential for faulty devices as a result of depleted batteries.
- 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
- 2,152 pieces
- Distribution
- US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.
- Lot, serial or model codes
- Model Number: 8008000. UDI-DI (Case): 05030267166497. UDI-DI (Single Unit): 5030267150649. Lot Numbers: 1240555, 1240793.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 1000120301
- Firm city
- East Syracuse
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28