Recall Z-2185-2025 ยท CCW Laryngoscope, Rigid
Flexicare Medical (Dongguan) Ltd.
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
| Date | Aug 1, 2025 (initiated Jul 11, 2025) |
| Status | Open, Classified |
| Reason | Laryngoscope handles may not illuminate as intended. |
| Root cause | Nonconforming Material/Component |
| Action | On July 11, 2025, Flexicare Medical Limited issued a Urgent: Medical Device Recall notification to affected consignees via E-Mail. Flexicare ask consignees to take the following actions: 1. Review Inventory for affected product and immediately quarantine. 2. All affected devices must be manually checked using the following procedure within customer notification. 3. All devices which demonstrate a failure to illuminate shall be withdrawn from use, quarantined, and returned. 4. If tested devices illuminate, they can continue to be used. Please ensure you subsequently continue to follow the Pre- |
| Distribution | US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.