BD Vacutainer® SST™ II Advance 367955Recalls & reported problems
Becton, Dickinson U.K. Limited · BD Vacutainer® SST™ II Advance · Class 2
All models of BD Vacutainer SST II Advance (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer SST II Advance blood collection tube has 1,459 FDA adverse event reports, with 1,456 malfunctions, 3 injuries and no deaths. The reports mostly describe wrong or unreliable test results, tubes not filled to the right amount, and leaks or splashes. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,478
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,478 adverse event reports that list this exact device (DI 30382903679554), received between Nov 27, 2017 and Sep 30, 2026 — classified as 3 injuries, 1,475 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (318 reports).
3 other recalls cover devices cleared under the same FDA submission (BK050036); 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings318
- Short Fill289
- Device Ingredient or Reagent Problem287
- Leak/Splash124
- Device Contamination with Chemical or Other Material119
- Incorrect Or Inadequate Test Results83
- Material Deformation78
- Volume Accuracy Problem61
Patient problems
- No Clinical Signs, Symptoms or Conditions983
- No Known Impact Or Consequence To Patient372
- No Consequences Or Impact To Patient67
- No Information36
- No Patient Involvement17
- Insufficient Information2
- Blood Loss1
- Hemolysis1
Recent adverse event reports
The 25 most recent of 1,478 reports, 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 50954889 ↗MalfunctionSep 29, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935964 ↗MalfunctionSep 29, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935962 ↗MalfunctionSep 24, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890862 ↗MalfunctionSep 24, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889794 ↗MalfunctionSep 24, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889054 ↗MalfunctionSep 23, 2026Short Fill
It was reported while using "[brand name]" there was poor barrier separation seen in (x) tube(s). No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870275 ↗MalfunctionSep 23, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863111 ↗MalfunctionSep 21, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846040 ↗MalfunctionSep 21, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841669 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820963 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient 7 of 13:It was reported that when using the BD Vacutainer® SST¿ II Advance Plus Blood Collection Tubes, elevated Na and K parameters were observed. Upon repeat of the same sample the results were normal. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820962 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820961 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820959 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820958 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820957 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820956 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820955 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient 11 of 13:It was reported that when using the BD Vacutainer® SST¿ II Advance Plus Blood Collection Tubes, elevated Na and K parameters were observed. Upon repeat of the same sample the results were normal. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820953 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820951 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient 2 of 13:It was reported that when using the BD Vacutainer® SST¿ II Advance Plus Blood Collection Tubes, elevated Na and K parameters were observed. Upon repeat of the same sample the results were normal. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820950 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820949 ↗MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775084 ↗MalfunctionJul 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021570 ↗MalfunctionJul 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021544 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under BK050036. One submission often covers many models, so check the product and lot details in each record.
- Z-1618-2022 · May 25, 2022 · Open, Classifieda. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/
- Z-0968-2018 · Aug 29, 2017 · TerminatedBD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing an
- Z-2434-2015 · Jun 23, 2015 · TerminatedBD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
Other Tubes, vials, systems, serum separators, blood collection devices
- BD Vacutainer® SST™ 367986Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls2,711 reports
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall1,744 reports
- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units 367962Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall693 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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