Medline ENT199235Recalls & reported problems
Medline Industries, Inc. · PUMP,FEEDING,ENTERAL,ENTRAFLO,PURCHASE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10888277420045), received between Mar 2, 2026 and Sep 28, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (4 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
- Device Alarm System4
- Electrical /Electronic Property Problem3
- Battery Problem2
- Break2
- Pumping Stopped2
- Audible Prompt/Feedback Problem1
- Device Emits Odor1
- Display or Visual Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Feeding Problem1
- Multiple Organ Dysfunction Syndrome1
- Renal Failure1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916936 ↗MalfunctionSep 25, 2026Device Alarm System; Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903488 ↗MalfunctionSep 25, 2026Pumping Stopped
It was reported that THE FEEDING PUMP STOPPED WORKING WHILE SHE WAS FEEDING HER MOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899458 ↗MalfunctionSep 21, 2026Device Alarm System; Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846722 ↗MalfunctionSep 18, 2026Failure to Pump
It was reported that "pump no longer works, tried to switch batteries."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828928 ↗MalfunctionSep 16, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Feeding Problem
MAUDE report 50789737 ↗MalfunctionSep 16, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789662 ↗MalfunctionSep 16, 2026Device Emits Odor; Failure to Power Up; Electrical Shorting
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788393 ↗MalfunctionSep 11, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740794 ↗MalfunctionSep 10, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716262 ↗MalfunctionSep 9, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698227 ↗MalfunctionSep 8, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674966 ↗MalfunctionSep 8, 2026Battery Problem; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669439 ↗MalfunctionSep 4, 2026Electrical /Electronic Property Problem
It was reported that "THE FEEDING PUMP STOP WORKING. IT DOES NOT RUN ANYMORE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50618338 ↗MalfunctionSep 4, 2026Electrical /Electronic Property Problem; Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614833 ↗MalfunctionSep 3, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589822 ↗MalfunctionSep 2, 2026Pumping Problem
Patient problems: Multiple Organ Dysfunction Syndrome; Renal Failure
MAUDE report 50572810 ↗MalfunctionSep 2, 2026Device Alarm System; Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567608 ↗MalfunctionSep 2, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566855 ↗MalfunctionMar 2, 2026Infusion or Flow Problem
ACCORDING TO THE FACILITY, THE "PUMP WAS SET TO DELIVER 480CC OVER 2 HOURS AND A TOTAL OF 480CC WAS PUT IN THE BAG. AFTER THE DOSE LIMIT OF 480CC WAS REACHED THERE WAS STILL APPROXIMATELY 70CC LEFT IN THE BAG, THE TOTAL 480CC WASN'T DELIVERED TO THE PATIENT." THE CUSTOMER REPORTS THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24491538 ↗
Other Pump, infusion, enteral devices
- Kangaroo 775100Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL988 reports
- Kangaroo 382400Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL677 reports
- Kangaroo 383400Cardinal Health, Inc. · Pump, Infusion, Enteral1 death659 reports
- Infinity Enteral Feeding Pump INFKIT2Zevex International, Inc. · Pump, Infusion, Enteral2 deaths407 reports
- Infinity Enteral Feeding Pump INFP01Zevex International, Inc. · Pump, Infusion, Enteral1 death207 reports
- Perfusor® 8713030UB. Braun Medical Inc. · Pump, infusion, enteral2 recalls3 deaths76 reports
- Kangaroo 775659Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL1 death139 reports
- Perfusor® 8713031UB. Braun Medical Inc. · PUMP, INFUSION, ENTERAL1 recall21 deaths87 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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