BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection TubesRecalls & reported problems across all models
Becton, Dickinson And Company · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,172
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 4 models of BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1,172 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Sep 29, 2026 — classified as 4 injuries, 1,168 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (309 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes problems
Device problems
- Device Contamination with Chemical or Other Material309
- Short Fill275
- Leak/Splash129
- Coagulation in Device or Device Ingredient103
- Device Markings/Labelling Problem72
- Volume Accuracy Problem70
- Incorrect, Inadequate or Imprecise Result or Readings48
- Material Protrusion/Extrusion45
Patient problems
- No Clinical Signs, Symptoms or Conditions683
- No Known Impact Or Consequence To Patient343
- No Consequences Or Impact To Patient94
- No Patient Involvement28
- No Information21
- No Code Available2
- Chemical Exposure1
- Exposure to Body Fluids1
BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367859Tubes, vials, systems, serum separators, blood collection89 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367835Tubes, vials, systems, serum separators, blood collection63 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367855Tubes, vials, systems, serum separators, blood collection10 reports
Recent BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Short Fill
It was reported while using BD Vacutainer® K2 EDTA (K2E) 5.4mg 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 50935963 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761311 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761307 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761304 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761246 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761243 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756465 ↗MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698866 ↗MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693877 ↗MalfunctionAug 4, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133856 ↗MalfunctionAug 4, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132920 ↗MalfunctionJun 22, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING CENTRIFUGATION OF BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, ONE TUBE BROKE RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578776 ↗MalfunctionJun 18, 2026Short Fill
IT WAS REPORTED DURING USE FIVE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, HAD INSUFFICIENT NEGATIVE PRESSURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551951 ↗MalfunctionJun 12, 2026Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES APPEARED TO CLOTTED POST CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491615 ↗MalfunctionJun 10, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453121 ↗
Other Becton, Dickinson And Company products
- BD Vacutainer SST10 models · 4,985 reports · 3 recalls
- BD Luer-Lok48 models · 5,117 reports
- BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
- BD SafetyGlide17 models · 2,185 reports
- BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
- BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
- BD Nexiva25 models · 1,614 reports · 1 recall
- BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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