Hollister Ulc recalls Onli 17cm Hydrophilic Urethral Intermittent Catheter

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.

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.

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 the steps below: 1. Please complete and return the response form attached as soon as possible, even if you do not have product in your possession and send the form to ComplaintCommunication@Hollister.com. 2. If you have supplied or transferred any potentially affected product to another facility or organization, provide that facility with a copy of this letter immediately. For further information or to request replacement devices please contact us: By phone Please contact one of the following: If you are a consumer or healthcare professional, please call: 1.888.808.7456 If you are a dealer, distributor, Institution, or pharmacy, please call: 1.800.323.4060 option 1"

• FDA enforcement recordOfficial FDA database entry for Z-2998-2026
• FDA 510(k) clearance · K211436The device's official FDA premarket clearance record
• FDA device classification · GBMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5130The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hollister UlcSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.