BD Vacutainer® SST™ 367988Recalls & reported problems

Summary

The FDA's MAUDE database contains 472 adverse event reports that list this exact device (DI 30382903679882), received between Nov 27, 2017 and Sep 30, 2026 — classified as 12 injuries, 460 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (109 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1618-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 472 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952595 ↗
• MalfunctionSep 30, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951848 ↗
• MalfunctionSep 30, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951846 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948293 ↗
• MalfunctionSep 16, 2026Fluid/Blood Leak; Material Deformation

  It was reported that when using the BD Vacutainer® SST¿ Blood Collection Tubes, about twenty (20) tubes that exhibited rough or cracked edges, resulting in blood leakage in the centrifuge. No adverse impact was reported regarding the patient or user.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788751 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 8 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243289 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 10 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243287 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 9 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243285 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 2 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243284 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 5 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243283 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 1 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243282 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 7 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243281 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 6 OF 10. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243280 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 4 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243279 ↗
• MalfunctionMay 21, 2026Short Fill

  REPORT 3 OF 10: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INADEQUATE BLOOD FLOW WAS SEEN WITH ONE PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243278 ↗
• MalfunctionApr 29, 2026Short Fill

  REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, TWO (2) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037143 ↗
• MalfunctionApr 29, 2026Short Fill

  REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ 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 25037134 ↗
• MalfunctionApr 3, 2026Device Contamination with Chemical or Other Material; Missing Information

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 18 TUBES HAVE AN UNKNOWN BLACK SUBSTANCE INSIDE, 13 TUBES HAVE A WHITE CLOUDY SUBSTANCE INSIDE, AND AN UNSPECIFIED NUMBER OF TUBES ARE MISSING THEIR LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777482 ↗
• MalfunctionMar 24, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED AND HAD POOR BARRIER SEPARATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682840 ↗
• MalfunctionMar 12, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED AND EXPERIENCED POOR BARRIER SEPARATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576930 ↗
• MalfunctionFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THROUGH A SURVEY THAT AFTER USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, ERRONEOUS RESULTS (ELEVATED PLATELETS AND POTASSIUM) WERE SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339214 ↗
• MalfunctionJan 27, 2026Product Quality Problem

  IT WAS REPORTED THAT BEFORE USING ONE (1) BD VACUTAINER® SST¿, THE TUBE EXHIBITED FLASH ON THE STOPPER CAUSING DIFFICULTY REMOVING THE TUBE FROM THE COLLECTION DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192051 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT ELEVATED POTASSIUM RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184160 ↗
• MalfunctionJan 13, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, POOR BARRIER SEPARATION WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES RESULTING IN RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063093 ↗
• MalfunctionJan 12, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SST¿, SIX TUBES WERE RECEIVED WITH NO LABELS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048623 ↗

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-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.