FDA-Device2026-09-02Class IIPROCESSING DEFECT
Hollister Onli Hydrophilic Urethral Intermittent Catheters recalled for manufacturing defect causing trauma risk
What this means
Hollister has identified a manufacturing defect in select lots of Onli Hydrophilic Urethral Intermittent Catheters that may cause a protrusion on the catheter tip. This defect could lead to genitourinary trauma or bleeding during use.
- Check if your catheter matches one of the affected SKU/REF numbers (82081, 82101, 82121, 82141, 82084, 82104, 82124, 82144, 82164, 85124, 85144, or 85164) and lot number listed in the recall notice.
- Contact Hollister or your healthcare provider if you have an affected catheter.
- Do not use an affected catheter if you have noticed any unusual protrusion or damage to the tip.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
2526120 units
Manufactured in
Foxford Road, REHINS, Ballina, N/A, Ireland
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2998-2026Want us to check the next one for you?
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