BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection TubesRecalls & reported problems across all models
Becton, Dickinson And Company · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 683
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 683 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2017 and Sep 30, 2026 — classified as 683 malfunctions.
The most frequently reported specific device problem is “Short Fill” (317 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 29, 2017Class IITerminated
A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
Z-0968-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes problems
Device problems
- Short Fill317
- Volume Accuracy Problem128
- Device Contamination with Chemical or Other Material59
- Leak/Splash45
- Coagulation in Device or Device Ingredient35
- Incorrect, Inadequate or Imprecise Result or Readings33
- Device Markings/Labelling Problem27
- Material Deformation23
Patient problems
- No Clinical Signs, Symptoms or Conditions398
- No Known Impact Or Consequence To Patient223
- No Consequences Or Impact To Patient38
- No Information14
- No Patient Involvement8
- Skin Inflammation/ Irritation3
- Pain2
- Discomfort1
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes 367841Tubes, vials, systems, serum separators, blood collection1 recall664 reports
- BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes 367842Tubes, vials, systems, serum separators, blood collection19 reports
Recent BD Vacutainer K2 EDTA (K2E) 3.6mg 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 30, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955061 ↗MalfunctionSep 28, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926540 ↗MalfunctionSep 28, 2026Short Fill
It was reported that when using the BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes, one (1) tube underfilled, requiring recollection. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915166 ↗MalfunctionSep 24, 2026Overfill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890857 ↗MalfunctionSep 24, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889790 ↗MalfunctionSep 23, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870507 ↗MalfunctionSep 16, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793763 ↗MalfunctionSep 11, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733222 ↗MalfunctionJun 30, 2026Short Fill
REPORT 3 OF 4. IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673045 ↗MalfunctionJun 30, 2026Short Fill
REPORT 4 OF 4. IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673040 ↗MalfunctionJun 30, 2026Short Fill
REPORT 1 OF 4. IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673039 ↗MalfunctionJun 30, 2026Short Fill
REPORT 2 OF 4 IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673037 ↗MalfunctionJun 30, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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 25671885 ↗MalfunctionJun 3, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25383645 ↗MalfunctionJun 1, 2026Short Fill
REPORT 1 OF 4. IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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 25356359 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page