Device recall
Z-2998-2026: Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081…
FDA device recall · Class II · Hollister Ulc
Key facts
| Recall number (Z-number) | Z-2998-2026 |
|---|---|
| Recall event | 99497 |
| Product | Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter… |
| Product code | GBM |
| Recalling firm | Hollister Ulc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K211436 |
| FEI number | 3005028195 |
At a glance
- 1–9 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