Onli 82164-30Recalls & reported problems
Hollister Incorporated · Ready to Use Hydrophilic Intermittent Catheter, 16 Fr 16 in/40cm, Straight · Class 2
All models of Onli (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075056279), received between Jan 11, 2022 and Jan 11, 2022 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
END USER OF THE HOLLISTER ONLI INTERMITTENT URINARY CATHETER HAS REPORTED THAT HE HAS EXPERIENCED 4 UTIS OVER THE LAST 2 YEARS OF USING THESE CATHETERS. HIS LAST UTI WAS IN THE BEGINNING OF DECEMBER AND HE WAS PRESCRIBED CIPRO AND NITROFURANTOIN. HE CATHETERIZES 4X/DAY AND DOESN'T FEEL LIKE HE IS FULLY EMPTYING HIS BLADDER. HE STATES HE USES STERILE TECHNIQUE AND DOES NOT REUSE THE CATHETERS. HIS DOCTOR HAS SUGGESTED HE INCREASE THE FREQUENCY OF CATH'ING FROM 4 TO 6X/DAY. HE DENIES ANY DEVICE MALFUNCTION. THE DOCTORS COULD NOT DETERMINE THE ROOT CAUSE OF HIS UTIS.
Patient problems: Urinary Tract Infection
MAUDE report 13224269 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page