Medex MX5311LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10351688506795), received between Jan 30, 2024 and Sep 30, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949831 ↗
• MalfunctionJul 28, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059246 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT STOPCOCK ATTACHED NEAREST TO PATIENT ON PICC LINE (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753995 ↗
• MalfunctionMar 4, 2026Contamination

  IT WAS REPORTED THAT ONE UNIT WITH A FREE-FLOATING PARTICULATE WAS IDENTIFIED DURING VISUAL INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513814 ↗
• MalfunctionFeb 11, 2026Disconnection

  IT WAS REPORTED THAT A STOPCOCK CONTROL VALVE DISCONNECTED FROM ITS HOUSING WHILE IN USE. PER REPORTER, THE DEVICE HAD BEEN IN USE FOR THREE DAYS AND WAS FULLY DISCONNECTED FROM THE LINE IT CONTROLLED, MAKING IT IMPOSSIBLE TO REGULATE FLOW FROM THE ASSOCIATED FEMORAL ARTERIAL LINE. REPORTER STATED THE EVENT OCCURRED WHILE ATTEMPTING TO DRAW BLOOD FROM THE ARTERIAL LINE, AS THE WHITE STOPCOCK VALVE BECAME DISCONNECTED DURING TURNING. THERE WAS NO PATIENT HARM, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S ARTERIAL LINE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317918 ↗
• MalfunctionFeb 5, 2026Separation Problem

  IT WAS REPORTED THAT IT APPEARED TO BECOME STRIPPED AND THEN CAME APART. THIS WAS CHALLENGING WHEN PATIENTS WERE ON MULTIPLE DRIPS. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270180 ↗
• MalfunctionFeb 4, 2026Defective Component

  IT WAS STATED THAT THE EMPLOYEE WAS USING 3-WAY STOP CLOCK ON (B)(6) 2025 WHEN PERFORMING A NUCLEAR MEDICINE STRESS TEST. DURING THE ISOTOPE INJECTION, THE SYRINGE CAME OFF THE STOPCOCK AND CAUSED A SPILL. UPON INSPECTION, IT APPEARED THE STOPCOCK MALFUNCTIONED AND DID NOT TIGHTEN TO THE SYRINGE PROPERLY. AGAIN, ON (B)(6) 2025, EMPLOYEE WAS PERFORMING THE SAME TEST AND PRIOR TO INJECTING, HE TESTED THE STOPCOCK AND FOUND ANOTHER ONE THAT WAS NOT WORKING PROPERLY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. MEDICATION WAS BEING USED WITH THIS PRODUCT. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258100 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CLIENT WAS SEEN TWICE A WEEK BETWEEN (B)(6) 2025 THAT THE 3 WAY STOP COCK LEAKING ON MULTIPLE OCCASIONS, THE REPORTER AT FIRST THOUGHT IT WAS NOT CONNECTED APPROPRIATELY. THE REPORTER RECEIVED MULTIPLE CALLS FROM PATIENT THAT DRESSING IS LEAKING, NO OUTPUT IN DRAINAGE BAGS. THE LEAK ALWAYS CAME FROM 3 WAY STOP COCK CONNECTIONS. VISITS DONE AND EQUIPMENT ALL WELL PLACED, BUT STILL LEAKING, REQUIRING MULTIPLE DRESSING CHANGES TO NEPHROSTOMY SITES. THERE WERE 8-10 UNITS INVOLVED IN MULTIPLE INCIDENTS. THERE WAS A RISK OF INFECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22557875 ↗
• MalfunctionMay 27, 2025Contamination; Contamination

  IT WAS REPORTED THAT A FREE-FLOATING PARTICLE WAS DISCOVERED IN THE FINAL PRODUCT BAG. THIS DEFECT WAS DISCOVERED DURING VISUAL INSPECTION OF THE FINAL PRODUCT BAG DURING FINAL PRODUCT PACKAGING. THE PARTICLE WAS ISOLATED AND IDENTIFIED USING A FOURIER TRANSFORM INFRARED SPECTROSCOPY AND SCANNING ELECTRON MICROSCOPY. THE REPORT INDICATED THAT THE PARTICLE (S1) WAS CHARACTERIZED TO BE CONSISTENT WITH CHLORINATED POLYOLEFIN (POLYETHYLENE). THE MOST INTENSE PEAKS ARE THE SILICATE SI-O AND SI-O-SI PEAKS AT 1031 AND 1007 CM-1. THE RELATIVELY INTENSITY OF THE METHYLENE (CH2) PEAK AT 1443 CM-1 INDICATES THE HYDROCARBON IS HIGHLY CHLORINATED. THE ESTER PEAK AT 1726 CM-1 IS A RELATIVELY MINOR COMPONENT AS INDICATED BY ITS LOW INTENSITY AND IS LIKELY AN ADDITIVE OR MINOR DEGRADATION PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089270 ↗
• MalfunctionMay 6, 2025Contamination; Contamination

  IT WAS REPORTED THAT A DISCREPANT MATERIAL WAS IDENTIFIED. TWO (2) UNITS WITH EMBEDDED PARTICULATES, ONE (1) UNIT WITH A BLUE SPECK WITHIN THE FLUID PATH, AND TEN (10) UNITS WITH BLUE SPECKS ON THE OUTER/NON-PRODUCT CONTACT SURFACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971801 ↗
• MalfunctionSep 20, 2024Contamination; Contamination

  IT WAS REPORTED THAT A FREE-FLOATING PARTICLE WAS DETECTED IN THE FINAL PRODUCT BAG, LEADING TO A LOT TERMINATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274602 ↗
• MalfunctionJan 30, 2024Backflow; Break; Fluid/Blood Leak; Backflow; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT TWICE THE THREADS BROKE IN THE LUER LOCK VALVE; WHICH CAUSED LEAKING OF THE MEDICINE GIVEN TO THE PATIENT. THE OTHER TIME, THE LUER LOCK VALVE CAUSED BACK FLOW INTO THE PATIENTS IV. THE STOP COCKS HAVE BEEN PULLED FROM THE SHELF IN THIS AREA AND GIVEN TO THE CENTRAL SUPPLY TEAM. THERE WAS PATIENT INVOLVEMENT. ITEM BROKE WHILE PUSHING MEDS AND NO PATIENT HARM. EXACT WEIGHT OF THE PATIENT WAS 100.24 KG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607888 ↗