BD Vacutainer® SST™ 367986Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® SST™ · Class 2
All models of BD Vacutainer SST (10)
Data updated Oct 16, 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 blood collection tube is used to collect and separate blood samples. Its 2,710 reports mostly describe inaccurate test results, underfilled tubes, and contamination or problems with ingredients inside the tubes. The reports include no deaths and 279 injuries, and most list no clinical signs or impact for the patient. There are 2 recalls, one open and one closed, over tubes exposed to higher temperatures before delivery and stoppers that can come loose from the tube.
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
- 2,711
- Deaths reported
- 0
- Injuries reported
- 279
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2,711 adverse event reports that list this exact device (DI 30382903679868), received between Oct 30, 2017 and Sep 29, 2026 — classified as 279 injuries, 2,432 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (797 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
- Feb 13, 2018Terminated
Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
Z-2056-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings797
- Short Fill422
- Device Contamination with Chemical or Other Material233
- Device Ingredient or Reagent Problem230
- Device Markings/Labelling Problem215
- Incorrect Or Inadequate Test Results200
- Leak/Splash184
- Volume Accuracy Problem118
Patient problems
- No Clinical Signs, Symptoms or Conditions1,333
- No Known Impact Or Consequence To Patient1,111
- No Consequences Or Impact To Patient127
- No Information65
- Test Result42
- No Patient Involvement24
- Exposure to Body Fluids6
- No Code Available6
Recent adverse event reports
The 25 most recent of 2,711 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Short Fill; Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937959 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935973 ↗MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862900 ↗MalfunctionSep 21, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849040 ↗MalfunctionSep 21, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848280 ↗MalfunctionSep 21, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848279 ↗MalfunctionSep 16, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794655 ↗MalfunctionSep 16, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794635 ↗MalfunctionSep 16, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794634 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792823 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792822 ↗MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material
It was reported that before using the BD Vacutainer® SST¿ Blood Collection Tubes, black foreign matter was found in the rubber stopper of five (5) tubes. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775079 ↗MalfunctionSep 15, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773763 ↗MalfunctionSep 15, 2026Separation Problem
Report 1 of 3.It was reported that when using the BD Vacutainer® SST¿ Blood Collection Tubes, the stopper pops off of 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 50773379 ↗MalfunctionSep 15, 2026Separation Problem
Report 2 of 3It was reported that when using the BD Vacutainer® SST¿ Blood Collection Tubes, the stopper pops off of 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 50773377 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761239 ↗MalfunctionSep 14, 2026Short Fill
It was reported while using BD Vacutainer® SST¿ Blood Collection Tubes, 1 tube underfilled. The tube was replaced. There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757455 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported while using BD Vacutainer® SST¿ Blood Collection Tubes, 1 tube broke in the centrifuge and leaked. There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753323 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721206 ↗MalfunctionAug 31, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523181 ↗MalfunctionJul 27, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021573 ↗MalfunctionJul 27, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021572 ↗MalfunctionMay 28, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25324500 ↗MalfunctionMay 27, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ 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 25307635 ↗MalfunctionMay 21, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, FIVE (5) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249525 ↗
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® 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® 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 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