Device recall
Z-2445-2023: DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve…
FDA device recall · Class II · Invacare Corporation
Key facts
| Recall number (Z-number) | Z-2445-2023 |
|---|---|
| Recall event | 92645 |
| Product | DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR |
| Product code | ITJ |
| Recalling firm | Invacare Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1525712 |
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