Onli 17cm Hydrophilic Urethral Intermittent Catheter — Class II medical device recall Z-2998-2026
Ongoing recall by Hollister Ulc, reported 2026-09-02, distributed nationwide. Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrus
| Recall number | Z-2998-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hollister Ulc, Ballina, N/A, Ireland |
| Recall initiated | 2026-07-14 |
| Classified | 2026-08-21 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,526,120 units |
| UPC / GTIN / UDI-DI | 00610075072354, 00610075072361, 00610075072385, 00610075072392, 00610075072408, 00610075072415, 00610075072422, 00610075072439, 00610075072446, 00610075097432, 00610075097449, 00610075097456 |
| Lot numbers | 5E063, 5E073, 5E083, 5E233, 5E243, 5E253, 5E263, 5E273, 5E283, 5E293, 5E303, 5F033, 5F043, 5F053, 5F063, 5F073, 5F103, 5F113, 5F123, 5F133, 5F143, 5F153, 5F163, 5F173, 5F183, 5F193, 5F203, 5F213, 5F223, 5F273, 5F283, 5G013, 5G083, 5G093, 5G103, 5G113, 5G143, 5G153, 5G173, 5G183 and 88 more |
| Model numbers | 82081, 82084, 82101, 82104, 82121, 82124, 82141, 82144, 82164, 85124, 85144, 85164 |
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, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2998-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.