BD Vacutainer® SST™ 367983Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® SST™ · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Vacutainer SST is a blood collection tube. Many of its 1,065 reports describe tubes that are short-filled, leaking or contaminated, and some describe inaccurate results. The reports include no deaths and 3 injuries. One open recall, from May 2022, covers tubes that may have been exposed to high temperatures before delivery, which may have reduced their effectiveness.
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
- 1,075
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,075 adverse event reports that list this exact device (DI 30382903679837), received between Nov 4, 2017 and Sep 28, 2026 — classified as 3 injuries, 1,072 malfunctions.
The most frequently reported specific device problem is “Short Fill” (238 reports).
2 FDA recall records 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
- Feb 13, 2018Terminated
Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
Z-2055-2018 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Short Fill238
- Leak/Splash179
- Incorrect, Inadequate or Imprecise Result or Readings119
- Device Contamination with Chemical or Other Material102
- Volume Accuracy Problem76
- Fluid/Blood Leak73
- Incorrect Or Inadequate Test Results67
- Crack66
Patient problems
- No Clinical Signs, Symptoms or Conditions676
- No Known Impact Or Consequence To Patient306
- No Consequences Or Impact To Patient51
- No Information23
- No Patient Involvement13
- Exposure to Body Fluids4
- Needle Stick/Puncture2
- Blood Loss1
Recent adverse event reports
The 25 most recent of 1,075 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926546 ↗MalfunctionSep 28, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926543 ↗MalfunctionSep 28, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926170 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874597 ↗MalfunctionSep 21, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849055 ↗MalfunctionSep 21, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848686 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848289 ↗MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761291 ↗MalfunctionSep 14, 2026Short Fill
It was reported while using BD Vacutainer® SST¿ Blood Collection Tubes, 3 tubes underfilled. There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757454 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736894 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733224 ↗MalfunctionSep 10, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723074 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716220 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693878 ↗MalfunctionMay 28, 2026Short Fill
IT WAS REPORTED THAT AFTER DRAWING ONLY A SINGLE DROP OF BLOOD USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, BLOOD FLOW CEASED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319512 ↗MalfunctionMay 21, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, STREAKS OF RED FOREIGN MATTER WERE SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243288 ↗MalfunctionMay 20, 2026Material Deformation
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, ONE TUBE WAS CRACKED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231972 ↗MalfunctionMay 19, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, INSUFFICIENT NEGATIVE PRESSURE WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25224151 ↗MalfunctionMay 13, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES ARE NOT MAINTAINING A PROPER VACUUM. WHEN USING THE SYRINGE METHOD TUBES DO NOT DRAW BLOOD, REQUIRING STAFF TO MANUALLY PUSH BLOOD IN AND WHEN USING AN UNSPECIFIED BUTTERFLY COLLECTION SYSTEM TUBES ARE PUSHING BLOOD BACK TOWARDS THE VEIN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164086 ↗MalfunctionMay 13, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ONE TUBE WAS CRACKED AND LEAKED BLOOD. NO ADVERSE IMPACT WAS OBSERVED REGARDING PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163518 ↗MalfunctionMay 13, 2026Material Deformation
IT WAS REPORTED THAT WHEN USING BD VACUTAINER® SST¿, 3 TUBES RUPTURED DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161305 ↗MalfunctionMay 12, 2026Short Fill
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 5 TUBES UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25156695 ↗MalfunctionMay 12, 2026Short Fill
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 5 TUBES UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25156693 ↗MalfunctionMay 12, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 1 TUBE WAS BROKEN AND LEAKED BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148812 ↗MalfunctionMay 5, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ 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 25087479 ↗
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 · 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® SST™ II Advance 367955Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1,478 reports
- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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