Recall Z-2998-2026 ยท GBM Catheter, Urethral
Hollister Ulc
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) 8
| Date | Aug 21, 2026 (initiated Jul 14, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | Hollister issued an URGENT PRODUCT FIELD SAFETY NOTICE to its consignees on 7/16/2026 via USPS and email. The notice explained the issue, risk to health, and requested the consignee inspect each catheter for the potential presence of a protrusion (defect) located approximately 2 cm from the funnel. If a protrusion is identified, the catheter should not be used. Users should also review and follow the Instructions for Use (IFU) and ensure that the device is opened, handled, and inserted in accordance with the IFU. The notice also requested the following actions be taken: "Please follow th |
| Quantity | 2526120 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211436 | Intermittent Catheter (Not Finalized) Hollister Incorporated, Jan 27, 2022 |