BD Vacutainer® FX 5mg 4mg Blood Collection Tubes 368920Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382903689201), received between Jan 26, 2024 and Nov 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Short Fill” (5 reports).

6 other recalls cover devices cleared under the same FDA submission (K901449); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® FX 5MG 4MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576906 ↗
• MalfunctionJun 12, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® FX 5MG 4MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195603 ↗
• MalfunctionNov 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Short Fill; Incorrect, Inadequate or Imprecise Result or Readings; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 5MG 4MG BLOOD COLLECTION TUBES, THERE WAS ONE DEVICE WITH LOW BLOOD FILL VOLUME. THE TUBE WAS TESTED FOR GLUCOSE AND ERRONEOUS RESULTS WERE REPORTED; HOWEVER, NO TREATMENT WAS CHANGED BASED ON THE RESULTS. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688413 ↗
• MalfunctionNov 13, 2024Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 5MG 4MG BLOOD COLLECTION TUBES, THERE WERE TWO (2) TUBES THAT UNDERFILLED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678015 ↗
• MalfunctionJul 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Short Fill; Incorrect, Inadequate or Imprecise Result or Readings; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 5MG 4MG BLOOD COLLECTION TUBES THERE WAS UNDERFILL OF ONE TUBE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697415 ↗
• MalfunctionMay 20, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES, 1 SHELF PACK OF TUBES DID NOT HAVE A LABEL. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356308 ↗
• MalfunctionJan 26, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES THE STOPPER POPPED OUT OF THE TUBE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K901449. One submission often covers many models, so check the product and lot details in each record.

• Z-2309-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
• Z-2298-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
• Z-2297-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
• Z-2296-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
• Z-2310-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
• Z-2299-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884