BD Vacutainer® Urine Collection Cups 364975Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 50382903649759), received between Oct 23, 2023 and Mar 25, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER USING BD VACUTAINER® URINE COLLECTION CUPS, A HEALTHCARE PROFESSIONAL RECEIVED A DIRTY NEEDLESTICK INJURY TO THE LEFT INDEX FINGER WHEN ATTEMPTING TO PLACE A STICKER OVER THE INOCULATING PORT. EMPLOYEE WAS LATER SEEN AT THE EMERGENCY ROOM. NO REPORT OF POST EXPOSURE TESTING OR MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24688237 ↗
• InjuryJan 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT FOLLOWING SPECIMEN COLLECTION WITH BD VACUTAINER® URINE COLLECTION CUPS, A HEALTH CARE WORKER EXPERIENCED A NEEDLE-STICK INJURY INVOLVING 1 DEVICE WHILE ATTEMPTING TO STRAIGHTEN A NEEDLE IN THE CAP THAT APPEARED TO BE BENT. IT WAS NOT SPECIFIED WHETHER THERE WAS POST-EXPOSURE TESTING OR MEDICAL INTERVENTION REQUIRED. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOW DID THE NEEDLE STICK INCIDENT OCCUR: ¿PHLEBOTOMIST TRIED SEVERAL MORE TIMES TO FILL TUBE AND NOTICED NEEDLE IN THE CAP APPEARED BENT AND TRIED TO BEND NEEDLE STRAIGHT TO BE ABLE TO PENETRATE THE BD VACUTAINER TUBE FOR COLLECTION. PHLEBOTOMIST DID NOT REALIZE THERE WAS A NEEDLE INSIDE THE SHEATH OF CAP AND ACQUIRED A SMALL NEEDLE STICK.¿

  Patient problems: Needle Stick/Puncture

  MAUDE report 24027261 ↗
• MalfunctionNov 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUPS THERE WERE FALSELY INCREASED RBC COUNT RESULTS CAUSED BUT THE SLEEVE IN THE DEVICE LID. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599368 ↗
• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUPS THE HEALTH CARE PROFESSIONAL EXPERIENCED A NEEDLE STICK INJURY FROM THE CANNULA ON THE DEVICE LID. NO ADVERSE IMPACT OR TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF MEMBER ATTEMPTED TO REMOVE THE STICKER TO TRANSFER THE UA INTO TUBES, SHE ATTEMPTED TO REMOVE IT MULTIPLE TIMES AND WHEN FINALLY, IT CAME OFF - SHE STUCK HERSELF WITH A NEEDLE BELOW THE STICKER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22797392 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER COLLECTION THE BD VACUTAINER® URINE COLLECTION CUPS A HEALTH CARE WORKER EXPERIENCED A NEEDLE STICK INJURY ON AN UNSPECIFIED NUMBER OF DEVICES. IT WAS REPORTED IT OCCURRED AFTER THE STICKER COVERING THE CANNULA HAD BEEN REMOVED OR IN THE PROCESS OF REMOVAL. THE HEALTH CARE WORKER UNDERWENT A BODY FLUID EXPOSURE WORK-UP. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A FEW ACCIDENTAL NEEDLESTICK INJURIES RELATED TO CUP LID. GENERALLY THE REPORT IS ABOUT TEAM MEMBERS STICKING THEMSELVES WHEN THEY WERE MOVING QUICKLY. FINGERS SLIPPED WHILE TRYING TO OPEN THE PACKAGE. BLOOD AND BODY FLUID EXPOSURE WORK UP DONE. NO ADDITIONAL TESTING/MEDICAL INTERVENTION NEEDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21950223 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER COLLECTION THE BD VACUTAINER® URINE COLLECTION CUPS A HEALTH CARE WORKER EXPERIENCED A NEEDLE STICK INJURY ON AN UNSPECIFIED NUMBER OF DEVICES. IT WAS REPORTED IT OCCURRED AFTER THE STICKER COVERING THE CANNULA HAD BEEN REMOVED OR IN THE PROCESS OF REMOVAL. THE HEALTH CARE WORKER UNDERWENT A BODY FLUID EXPOSURE WORK-UP. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A FEW ACCIDENTAL NEEDLESTICK INJURIES RELATED TO CUP LID. GENERALLY, THE REPORT IS ABOUT TEAM MEMBERS STICKING THEMSELVES WHEN THEY WERE MOVING QUICKLY. FINGERS SLIPPED WHILE TRYING TO OPEN THE PACKAGE. BLOOD AND BODY FLUID EXPOSURE WORK UP DONE. NO ADDITIONAL TESTING/MEDICAL INTERVENTION NEED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21950218 ↗
• MalfunctionApr 18, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED WHEN USING ONE BD VACUTAINER® URINE COLLECTION CUP, THE TRANSFER DEVICE FAILED TO EVACUATE URINE OTHER THAN A FEW DROPLETS. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865697 ↗
• MalfunctionFeb 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SHIPPING BOX OF BD VACUTAINER® URINE COLLECTION CUPS DEPICTED TWO LABELS WITH TWO DIFFERENT LOT NUMBERS. THE NUMBER OF OCCURRENCES IS UNSPECIFIED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359782 ↗
• InjuryNov 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHEN USING THE UNKNOWN BD VACUTAINER® URINE COMPLETE CUP KIT THE NURSE ACCIDENTLY INSERTING THEIR FINGER IN THE RECESSED SHARPS AREA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT NEEDLESTICK INJURIES WHILE USING BD URINE COLLECTION CUPS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18050333 ↗
• MalfunctionOct 23, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD VACUTAINER® URINE COLLECTION CUPS ARE SHARP WITH NO SAFETY MECHANISM. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE PRODUCT IS SHARP WITH NO SAFETY MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990692 ↗