Device recall
Z-2182-2025: BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U…
FDA device recall · Class I · Flexicare Medical (Dongguan) Ltd.
Key facts
| Recall number (Z-number) | Z-2182-2025 |
|---|---|
| Recall event | 97139 |
| Product | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3), |
| Product code | CCW |
| Recalling firm | Flexicare Medical (Dongguan) Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3006061749 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database