BD Vacutainer® SST™ 367989Recalls & reported problems

Summary

The FDA's MAUDE database contains 476 adverse event reports that list this exact device (DI 30382903679899), received between Nov 4, 2017 and Sep 30, 2026 — classified as 1 injury, 475 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (122 reports).

3 other recalls cover devices cleared under the same FDA submission (BK050036, K230855); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 476 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 50941469 ↗
• MalfunctionSep 15, 2026Device Markings/Labelling Problem

  It was reported that before using the BD Vacutainer® SST¿ Blood Collection Tubes, one (1) tube exhibited a missing label. No adverse impact was reported regarding the patient or user.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773794 ↗
• MalfunctionMay 13, 2026Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES HAD NO LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162887 ↗
• MalfunctionMay 11, 2026Short Fill

  IT WAS REPORTED DURING USE OF BD VACUTAINER® SST¿, 2 TUBES UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137088 ↗
• MalfunctionMay 8, 2026Separation Problem

  IT WAS REPORTED AFTER USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE STOPPER POPPED OFF ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130652 ↗
• MalfunctionApr 3, 2026Material Deformation

  IT WAS REPORTED DURING USE OF BD VACUTAINER® SST¿ , ONE TUBE HAD A MOLDING DEFECT WITH SHARP PROTRUSIONS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775782 ↗
• MalfunctionMar 25, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, TWO (1) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693117 ↗
• MalfunctionFeb 20, 2026Separation Problem

  IT WAS REPORTED AFTER USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE STOPPER POPPED OFF OF ONE (1) TUBE AFTER RECAPPING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408033 ↗
• MalfunctionFeb 20, 2026Improper Chemical Reaction

  IT WAS REPORTED AFTER USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WAS RED CELL HANG-UP SEEN IN THREE (3) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406107 ↗
• MalfunctionFeb 19, 2026Improper Chemical Reaction

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WAS POOR BARRIER SEPARATION SEEN IN 20 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24396957 ↗
• MalfunctionFeb 11, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE BUBBLES IN THE GEL SEPARATION BARRIER OF ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314354 ↗
• MalfunctionFeb 4, 2026Separation Failure

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ ON AN AUTOMATED INSTRUMENT, 1 TUBE EXHIBITED CLOSURE SEPARATION WHERE THE SHIELD AND STOPPER SEPARATED DURING CLOSURE REMOVAL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259707 ↗
• MalfunctionFeb 2, 2026Material Deformation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE FOUND TO BE BOWED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239970 ↗
• MalfunctionJan 21, 2026Crack

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 1 TUBE WAS CRACKED PRIOR TO PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136809 ↗
• MalfunctionJan 21, 2026Material Deformation

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿, 5 TUBES HAD RECESSED TUBE OPENINGS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136343 ↗
• MalfunctionJan 8, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003556 ↗
• MalfunctionJan 5, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 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 23968274 ↗
• MalfunctionJan 2, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ABNORMAL SEPARATION GEL WAS SEEN WITH FIVE TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951037 ↗
• MalfunctionJan 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, FOREIGN MATTER WAS SEEN INSIDE OF TWO TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951034 ↗
• MalfunctionDec 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SST¿, FIVE (5) TUBES PUSHED OFF FROM THE NON-PATIENT NEEDLE OF THE COLLECTION DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922426 ↗
• MalfunctionDec 24, 2025Separation Problem; Premature Separation; Separation Problem; Premature Separation

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SST¿ THAT THE CAP WAS LOOSE WHEN RE-CAPPING IN ONE TUBE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889049 ↗
• MalfunctionDec 22, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ TUBES, THERE WAS AN OCCURRENCE WHERE BLOOD COLLECTION NEEDLES AND TUBES SPRANG APART FROM THE TUBE IN FIVE (5) DEVICES. NO ADVERSE IMPACT WAS REPORTED FOR EITHER THE PATIENT OR THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872304 ↗
• MalfunctionDec 19, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 1 TUBE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857891 ↗
• MalfunctionDec 18, 2025Short Fill; Short Fill

  REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 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 23839549 ↗
• MalfunctionDec 18, 2025Short Fill; Short Fill

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 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 23839547 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under BK050036, K230855. 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.