BD Vacutainer® SST™ II Advance 367953Recalls & reported problems

Summary

The FDA's MAUDE database contains 454 adverse event reports that list this exact device (DI 30382903679530), received between Nov 27, 2017 and Aug 25, 2026 — classified as 454 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (84 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 454 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50440201 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE TUBES, 1 TUBE LEAKED BLOOD DUE TO A CRACK IN THE BOTTOM OF THE TUBE WHILE ON AN AUTOMATED INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203699 ↗
• MalfunctionApr 21, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, TWO TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945090 ↗
• MalfunctionApr 21, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THREE TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943361 ↗
• MalfunctionApr 21, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS 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 24943360 ↗
• MalfunctionApr 21, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, FIVE TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943358 ↗
• MalfunctionApr 3, 2026Separation Problem; Premature Separation

  REPORT 1 OF 2: IT WAS REPORTED AFTER USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THERE WERE STOPPER POPS OFF WITH LEAKAGE SEEN IN 1 TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781642 ↗
• MalfunctionApr 3, 2026Separation Problem; Premature Separation

  REPORT 2 OF 2. IT WAS REPORTED AFTER USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THERE WERE STOPPER POPS OFF WITH LEAKAGE SEEN IN 8 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781635 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, BLOOD POOLED IN THE WELL OF THE STOPPER; SO, WHEN THE TUBE WAS REMOVED FROM THE FUME HOOD AND TURNED OVER, BLOOD SPLASHED ONTO THE NURSE'S FACE. THE NURSE'S SKIN WAS INTACT WHEN THIS OCCURRED. THE NURSE THEN UNDERWENT SEROLOGICAL TESTING, AND THE OUTCOME WAS NOT REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24744838 ↗
• MalfunctionMar 23, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS 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 24669053 ↗
• MalfunctionMar 10, 2026Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, MISSING LABELS WERE SEEN ON 590 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559065 ↗
• MalfunctionMar 9, 2026Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, BLOOD LEAKS OUT OF AN UNSPECIFIED NUMBER OF TUBES DURING CENTRIFUGATION, STAINING THE SWING BUCKET. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552582 ↗
• MalfunctionFeb 6, 2026Product Quality Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, THE RUBBER STOPPER OF ONE TUBE WAS FOUND TO BE BLUE INSTEAD OF THE EXPECTED YELLOW TONE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283803 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, ONE TUBE WAS CRACKED RESULTING IN SAMPLE LEAKAGE IN THE ANALYZER, COBAS 417. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184151 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125936 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125934 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125933 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125932 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125931 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125910 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125560 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125291 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125268 ↗
• MalfunctionJan 20, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES AND GEL SMEARING AFTER PROCESSING THAT CLOGGED THEIR INSTRUMENT PROBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125258 ↗
• MalfunctionJan 6, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SST¿ II ADVANCE, 1 TUBE HAD WHITE SPOTS INSIDE THE TUBE (ADDITIVE ABNORMALITY). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980597 ↗

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, Classified
  a. 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 · Terminated
  BD 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 · Terminated
  BD 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.