Device recall
Z-1961-2025: MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and…
FDA device recall · Class I · Integra LifeSciences Corp. (NeuroSciences)
Key facts
| Recall number (Z-number) | Z-1961-2025 |
|---|---|
| Recall event | 96965 |
| Product | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids. |
| Product code | FMF |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences) |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K082454 |
| FEI number | 3003418325 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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