FDA recall, , Moderate risk
Hollister Onli Hydrophilic Urethral Intermittent Catheters
The Onli 17cm Hydrophilic Urethral Intermittent Catheter may have a protrusion that could cause genitourinary trauma or bleeding.
Summary by Recall Canary from the FDA notice
What happened
Hollister Ulc of Ballina, Ireland, began a recall of select lots of Onli Hydrophilic Urethral Intermittent Catheters on July 14, 2026, because a manufacturing defect may cause a protrusion that might lead to genitourinary trauma or bleeding. The recall covers multiple models including the Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as 82081 Ch08-17, 82101 Ch10-17, 82121 Ch12-17, 82141 Ch14-17, and the 82084 Ch08 40cm, among others, with distribution nationwide in the U.S.
The FDA added the recall to its Enforcement Report on August 21, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Onli 17cm Hydrophilic Urethral Intermittent Catheter
- SKU
- 82081
- 82101
- 82121
- UDI-DI
- 00610075072354
- 00610075072361
- 00610075072385
- 00610075072392
- 00610075072408
- 00610075072415
- 00610075072422
- 00610075072439
- 00610075072446
- 00610075097432
- 00610075097449
- 00610075097456
- Lot code
- 5F273
- 5F283
- 5H293
- 5J153
- 6C313
- 5G013
- 5K253
- 6A303
- 5H283
- 5K183
- 5K193
- 5K213
- 6A253
- 6A263
- 6B053
- 5E063
- 5E073
- 5E083
- 5F193
- 5F203
- 5F213
- 5F223
- 6B133
- 5E293
- 5G213
- 5G223
- 6A223
- 6A213
- 5E303
- 5G243
- 5G253
- 5J063
- 5J073
- 5L153
- 6D203
- 6E293
- 5F033
- 5F063
- 5F043
- 5F053
- 5J223
- 5J283
- 5J243
- 5K143
- 6A163
- 6A153
- 6B173
- 6B183
- 5F073
- 5F113
- 5F133
- 5I073
- 5G083
- 5E243
- 5E253
- 5E233
- 5F103
- 5I123
- 5F143
- 5E263
- 5E273
- 5I113
- 5E283
- 5F123
- 5F153
- 5G093
- 5G183
- 5G173
- 5I153
- 5I133
- 5I143
- 5I063
- 6A173
- 6B243
- 5I103
- 6B223
- 6B233
- 6B253
- 6B263
- 6B213
- 6C033
- 6C043
- 6B273
- 6C013
- 6C023
- 6C053
- 6B283
- 5F163
- 5F183
- 5F173
- 5G103
- 5G143
- 5G113
- 5G153
- 6A233
- 6C253
- 6C243
- 6C223
- 6C233
- 6D303
- 6D293
- 6D283
- 5K133
- 6B193
- 5K123
- 5K113
- 5K053
- 5K043
- 5K063
- 5K073
- 6A113
- 6A133
- 5K103
- 6A123
- 6A093
- 6A103
- 6C283
- 6C263
- 6C273
- 6E013
- 5L053
- 5L043
- 6A083
- 5L193
- 6A023
- 5L223
- 6A053
- 6C293
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Hollister UlcBallina, Ireland
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99497
- Recall number
- Z-2998-2026
- Quantity recalled
- 2526120 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
