Onli 82164Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075072446), received between Jul 28, 2026 and Jul 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (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.

Recalls naming this device

1. 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Coagulation in Device or Device Ingredient

  It was reported that the patient experienced urinary tract infections (UTIs) while using Hollister's Onli catherter. It was also reported that the catheter lubricant was thicker than normal and appeared gel-like rather than liquid and the patient associated the frequent UTIs with the thick lubricant.

  Patient problems: Urinary Tract Infection

  MAUDE report 50061124 ↗