Drug recall
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral…
FDA recall event 99497 · Class II · Hollister Ulc
Key facts
| Event ID | 99497 |
|---|---|
| Recall numbers | Z-2998-2026 |
| Recalling firm | Hollister Ulc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding. |
| Initiation date | Jul 14, 2026 |
| Report date | Sep 2, 2026 |
| City | Ballina |
| Country | Ireland |
| FEI number | 3005028195 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: