OnliRecalls & reported problems across all models
Hollister Incorporated · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Onli model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 16 models of Onli by Hollister Incorporated in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2022 and Sep 18, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (1 report).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Onli recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 12 of these models · Recall details · FDA record ↗
Most reported Onli problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Coagulation in Device or Device Ingredient1
- Material Deformation1
Patient problems
- Urinary Tract Infection8
- Burning Sensation1
- Hematuria1
Onli models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Onli 82124CATHETER, URETHRAL1 recall1 report
- Onli 82144CATHETER, URETHRAL1 recall1 report
- Onli 82164CATHETER, URETHRAL1 recall1 report
- Onli 82081CATHETER, URETHRAL1 recall0 reports
- Onli 82101CATHETER, URETHRAL1 recall0 reports
- Onli 82121CATHETER, URETHRAL1 recall0 reports
- Onli 82141CATHETER, URETHRAL1 recall0 reports
- Onli 82084CATHETER, URETHRAL1 recall0 reports
- Onli 82104CATHETER, URETHRAL1 recall0 reports
- Onli 85124CATHETER, URETHRAL1 recall0 reports
- Onli 85144CATHETER, URETHRAL1 recall0 reports
- Onli 85164CATHETER, URETHRAL1 recall0 reports
- Onli 82144-30CATHETER, URETHRAL2 reports
- Onli 82164-30CATHETER, URETHRAL1 report
- Onli 82124-30CATHETER, URETHRAL1 report
- Onli 82121-30CATHETER, URETHRAL1 report
Recent Onli adverse event reports
The 8 most recent reports across all models, 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 ↗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 ↗InjurySep 12, 2023Adverse 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 HOLLISTER'S ONLI HYDROPHILIC INTERMITTENT URINARY CATHETER EXPERIENCED AN ANTIBIOTIC RESISTANT UTI. CUSTOMER ALSO REPORTED HE HAD A PICC LINE IN FOR A MONTH.
Patient problems: Hematuria; Urinary Tract Infection
MAUDE report 17728043 ↗InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN END USER REPORTED THAT SHE EXPERIENCED BURNING AND PELVIC PAIN WHILE USING THE HOLLISTER ONLI HYDROPHILIC URETHRAL CATHETER. SHE WENT TO SEE HER HEALTHCARE PROFESSIONAL; WAS TOLD SHE HAD A UTI AND WAS PRESCRIBED ANTIBIOTICS. SHE ALSO REPORTED THERE WERE NO PROBLEMS OPENING OR INSERTING THE CATHETERS AND THAT THE CATHETER WAS WELL HYDRATED.
Patient problems: Burning Sensation; Urinary Tract Infection
MAUDE report 16672902 ↗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 ↗InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN END USER WHO USES INTERMITTENT CATHETERS DEVELOPED A UTI WHILE USING THE HOLLISTER ONLI INTERMITTENT URINARY CATHETER. THE END USER REPORTED THAT HE HAS A SPINAL CORD INJURY AND HAS NO SENSATION. HE SAID HE WAS EXPERIENCING DIFFICULTIES INSERTING THE CATHETERS AND FELT RESISTANCE DURING INSERTION. HE SAID HE DEVELOPED URINARY LEAKAGE, WHICH IS HIS TYPICAL SYMPTOM OF A UTI. HE SAID HIS DOCTOR DIAGNOSED HIM WITH A UTI AND SAID THE CATHETERIZATION PROCESS PROBABLY CAUSED INFLAMMATION LEADING TO THE UTI. HE STATED THE DOCTOR PLACED HIM ON ANTIBIOTICS AND THE END USER IS NOW FEELING FINE. THE END USER STATED HE NORMALLY EXPERIENCES 3 UTIS A YEAR.
Patient problems: Urinary Tract Infection
MAUDE report 15536902 ↗InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN END USER WHO USES INTERMITTENT CATHETERS DEVELOPED A UTI WHILE USING THE HOLLISTER ONLI INTERMITTENT URINARY CATHETER. HE REPORTED THAT HIS LAST UTI WAS 2 YEARS AGO. HE EXPLAINED THAT IN AUGUST, AFTER USING THE ONLI CATHETERS FOR 1 TO 2 WEEKS AND CATHETERIZING UP TO 10 X DAY, HE SAID STARTED EXPERIENCING SYMPTOMS OF A UTI. HE STATED THE SYMPTOMS HE EXPERIENCED WERE CHANGES IN THE SMELL AND COLOR OF HIS URINE. HE REPORTED THAT HE DOES NOT HAVE ANY URINARY TRACT PAIN SENSATION, HOWEVER, HE DOES HAVE THE ABILITY TO EXPERIENCE URINARY FREQUENCY, WHICH HE EXPERIENCED. HE SAID HE WENT TO HIS DOCTOR ON AUGUST 20 AND HAD A UA DONE. THE DOCTOR REPORTEDLY SAID HE HAD A UTI AND PRESCRIBED HIM ORAL ANTIBIOTICS (HE DOES NOT KNOW THE NAME). HE STATED THAT THE DOCTOR DID NOT INDICATE A CAUSE OF HIS UTI. HE DENIES HAVING ANY DIFFICULTY USING THE CATHETERS OR CATHETERIZING HIMSELF. HE REPORTED THAT HE FEELS FINE NOW.
Patient problems: Urinary Tract Infection
MAUDE report 15536862 ↗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 Hollister Incorporated products
All Hollister Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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