Recall Z-2102-2025 ยท CCW Laryngoscope, Rigid
Intersurgical Inc
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
| Date | Jul 11, 2025 (initiated Jun 17, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.