Medline URO170816TRecalls & reported problems
Medline Industries, Inc. · 16FR 10ML TEMP SENS SILICONE TOTAL TRAY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medline catheter care tray includes a silicone urinary catheter with temperature sensing. Reports mostly describe the sample port coming loose, stool getting into the catheter or sample port, leaks, balloons that would not inflate, and inaccurate temperature readings. Of 42 reports that name its identifier, there were no deaths and 25 injuries mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10888277866942), received between Dec 3, 2019 and Sep 23, 2026 — classified as 25 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
- Leak/Splash6
- Appropriate Device Problem Term/Code Not Available5
- Material Integrity Problem5
- Contamination3
- Fluid/Blood Leak3
- Obstruction of Flow3
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Urinary Incontinence4
- Insufficient Information3
- Incontinence1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
It was reported that "Sample port came off".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872497 ↗MalfunctionSep 21, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842973 ↗MalfunctionSep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810303 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780081 ↗MalfunctionSep 15, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775942 ↗MalfunctionSep 11, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50739849 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675246 ↗MalfunctionMay 14, 2026Device Sensing Problem
CUSTOMER REPORTED, A READING OF 103 AND EXTERNAL TEMPS CAME BACK AROUND 98. THEY DID NOT CONTINUE TAKING CATHETER TEMPS AFTER THE OCCURRENCE.
Patient problems: Insufficient Information
MAUDE report 25177138 ↗MalfunctionMar 24, 2026Contamination; Device Contamination with Body Fluid
ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, "WE HAVE HAD ANOTHER ISSUE WITH STOOL INTRUSION INTO THE FOLEY CATHETER."
Patient problems: Insufficient Information
MAUDE report 24677082 ↗InjuryJun 25, 2025Contamination; Device Contamination with Body Fluid; Contamination; Device Contamination with Body Fluid
ACCORDING TO THE FACILITY ON (B)(6) 2025 STOOL WAS REPORTED IN THE SAMPLE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329329 ↗InjuryJun 3, 2025Material Integrity Problem; Material Integrity Problem
SAMPLE PORT CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134577 ↗InjuryJun 2, 2025Material Separation; Material Separation
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE SAMPLE PORT "CAME OUT WITH LITTLE TO NO PRESSURE" REQUIRING THE CATHETER TO BE REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22126972 ↗InjuryMay 30, 2025Contamination; Contamination
ACCORDING TO THE FACILITY, ON 4/28/25, A PATIENT HAD AN INDWELLING URINARY CATHETER PLACED, AND THE PATIENT "HAD A BM (BOWEL MOVEMENT) WITH LIQUID STOOL THAT SOILED THE CATHETER SYSTEM AND SAMPLE PORT. THE LIQUID STOOL ENTERED THE CREVICE AROUND THE SAMPLE PORT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22113915 ↗InjuryMar 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE REPORT RECEIVED FROM CARDINAL HEALTH THE FOLEY CATHETER BALLOON WOULD NOT INFLATE REQUIRING THE CATHETER TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21576512 ↗InjuryMar 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE REPORT RECEIVED FROM CARDINAL HEALTH THE FOLEY CATHETER BALLOON WOULD NOT INFLATE REQUIRING THE CATHETER TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572891 ↗MalfunctionOct 11, 2024Inflation Problem; Inflation Problem
CATHETER INFLATION VALVE WOULD NOT ALLOW FOR INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427204 ↗InjuryOct 10, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE FACILITY, "SOMETIME IN LATE AUGUST DURING PREP FOR A CARDIAC PROCEDURE, THE PA WAS NOT ABLE TO INFLATE THE BALLOON ONCE IN THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418264 ↗InjuryOct 9, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE CUSTOMER, AFTER INSERTING A FOLEY CATHETER, THEY WERE NOT ABLE TO "INFLATE THE BALLOON ONCE IN THE PATIENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407988 ↗InjuryOct 9, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE CUSTOMER, ON 09/11/2024 AFTER INSERTING A FOLEY CATHETER, THEY WERE NOT ABLE TO "INFLATE THE BALLOON ONCE IN THE PATIENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407914 ↗InjuryJun 17, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE FACILITY "THE CATHETER WOULD NOT DRAIN PAST THE CONNECTION WHERE THE ACTUAL CATHETER MEETS THE TUBING".
Patient problems: Unspecified Infection
MAUDE report 19547308 ↗InjuryJun 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON 5/9, "THE SAMPLE PORT DETACHED, THE DEVICE WAS REMOVED AND WAS REPLACED BY A NEW CATHETER. THE PATIENT WAS NOT HARMED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19512914 ↗InjuryMar 14, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE CUSTOMER, ON 01/30/2023 THE CATHETER WAS NOTED TO BE "LEAKING", THE INDIVIDUAL WAS "VOIDING AROUND CATHETER", AND THE FOLEY WAS REPLACED.
Patient problems: Urinary Incontinence
MAUDE report 18909505 ↗InjuryMar 14, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 THE CATHETER WAS NOTED TO BE "LEAKING", THE INDIVIDUAL WAS "VOIDING AROUND CATHETER", AND THE FOLEY WAS REPLACED.
Patient problems: Urinary Incontinence
MAUDE report 18909429 ↗InjuryMar 14, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 THE CATHETER WAS NOTED TO BE "LEAKING", THE INDIVIDUAL WAS "VOIDING AROUND CATHETER", AND THE FOLEY WAS REPLACED.
Patient problems: Urinary Incontinence
MAUDE report 18909342 ↗InjuryMar 14, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 THE CATHETER WAS NOTED TO BE "LEAKING", THE INDIVIDUAL WAS "VOIDING AROUND CATHETER", AND THE FOLEY WAS REPLACED.
Patient problems: Urinary Incontinence
MAUDE report 18905832 ↗
Other Catheter care tray devices
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- Bardia® Foley Catheter Insertion Tray 802010C. R. Bard, Inc. · Catheter care tray54 reports
- Medline DYND10160Medline Industries, Inc. · Catheter care tray1 recall4 reports
- Medline DYNC1816Medline Industries, Inc. · Catheter care tray1 recall2 reports
- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- MEDLINE URO4RR16CMedline Industries, Inc. · Catheter care tray1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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