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Onli 82124-30Recalls & reported problems

Hollister Incorporated · Ready to Use Hydrophilic Intermittent Catheter, 12 Fr 16 in/40cm, Straight · Class 2

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 00610075060658), received between Dec 6, 2022 and Dec 6, 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. How this data works · Data updated Oct 13, 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.

  • InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING THE ONLI HYDROPHILIC CATHETERS FOR 3 YEARS, DEVELOPED A UTI. IT WAS REPORTED THAT THE PATIENT WAS CATHERIZING FOR URINE VIA A MITROFANOFF STOMA AND KLEBSIELLA WAS IDENTIFIED VIA URINE CULTURE. IT WAS FURTHER REPORTED THAT THE END USER WAS PLACED ON ORAXIM AND ORELOX ANTIBIOTICS FOR 10 DAYS TO TREAT THE INFECTION.

    Patient problems: Urinary Tract Infection

    MAUDE report 15925397 ↗

Other CATHETER, URETHRAL devices

All CATHETER, URETHRAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.