Onli 82124Recalls & reported problems
Hollister Incorporated · Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075072422), received between Sep 18, 2026 and Sep 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jul 14, 2026Open, Classified
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.
Z-2998-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Deformation1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Material Deformation
It was reported that a Hollister Onli Hydrophilic Intermittent Catheter was difficult to insert due to a protrusion in the middle of the catheter. It was reported that during removal of the catheter from the urethra, it caused a urethral injury and then he experienced a bladder infection.
Patient problems: Urinary Tract Infection
MAUDE report 50817741 ↗
Other CATHETER, URETHRAL devices
- Bardex® All-Silicone Foley Catheter 165814C. R. Bard, Inc. · CATHETER, URETHRAL275 reports
- GENTLECATH 421911Convatec, Purchasing Department · Catheter, Urethral234 reports
- GENTLECATH 421910Convatec, Purchasing Department · Catheter, Urethral122 reports
- CURE CATHETER M16CConvatec, Purchasing Department · Catheter, Urethral95 reports
- GENTLECATH 421909Convatec, Purchasing Department · Catheter, Urethral66 reports
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82144Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.