BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® PST™ Gel and Lithium Heparin (N) 56 Units · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer PST gel tube is a blood collection tube used to separate samples. Most of its 741 reports describe malfunctions, such as black dots of foreign matter inside tubes, air bubbles in the gel, short fills and inaccurate test results. The reports include no deaths and 15 injuries. One recall, started in June 2019 and now closed, concerns falsely elevated carboxyhemoglobin results, and reports fell from 124 in the prior 12 months to 39 in the latest 12 months.
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
- 747
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 747 adverse event reports that list this exact device (DI 30382903679608), received between Dec 1, 2017 and Sep 29, 2026 — classified as 15 injuries, 732 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (170 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Jun 12, 2019Class IITerminated
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Z-2301-2019 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings170
- Device Contamination with Chemical or Other Material122
- Device Ingredient or Reagent Problem122
- Short Fill104
- Incorrect Or Inadequate Test Results61
- Coagulation in Device or Device Ingredient59
- Separation Problem49
- Leak/Splash46
Patient problems
- No Clinical Signs, Symptoms or Conditions474
- No Known Impact Or Consequence To Patient191
- No Consequences Or Impact To Patient43
- No Information17
- No Patient Involvement12
- Hemolysis5
- Exposure to Body Fluids3
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 747 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Improper Chemical Reaction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937953 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935040 ↗MalfunctionSep 21, 2026Separation Problem
It was reported while applying the patient¿s barcode label onto the BD Vacutainer® PST¿ Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, the stopper of one (1) tube fell off, spilling the blood and requiring recollection. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842472 ↗MalfunctionSep 16, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794633 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763178 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763175 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Report 1 of 3.It was reported that before using the BD Vacutainer® PST¿ Gel and Lithium HeparinN 56 Units, a black dot of material was observed on the inner wall 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 50763173 ↗MalfunctionMay 28, 2026Separation Problem
IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, THE STOPPER POPPED OFF OF THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317467 ↗MalfunctionMay 18, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, AN UNSPECIFIED NUMBER OF TUBES CONTAIN FOREIGN MATTER (BLACK DOT). GEL AIR BUBBLES WERE ALSO REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209111 ↗MalfunctionMay 13, 2026Device Contamination with Chemical or Other Material
REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, FOREIGN MATTER (BLACK DOTS) WERE SEEN INSIDE OF 7 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165376 ↗MalfunctionMay 13, 2026Device Contamination with Chemical or Other Material
REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, FOREIGN MATTER (BLACK DOTS) WERE SEEN INSIDE OF 115 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165367 ↗MalfunctionMay 8, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 56 UNITS BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN 290 TUBES AND AIR BUBBLES IN GEL WAS FOUND IN 1248 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126873 ↗MalfunctionApr 29, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 56 UNITS, THERE WAS FOREIGN MATTER IN 307 TUBES AND BUBBLES IN THE GEL SEPARATION BARRIER OF 1138 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25037733 ↗MalfunctionApr 28, 2026Fluid/Blood Leak; Premature Separation
IT WAS REPORTED AFTER USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 56 UNITS, THE STOPPER CREPT OUT AND SAMPLE SPILLED IN 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 25021283 ↗MalfunctionApr 21, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, A BLACK DOT WAS SEEN INSIDE THE INNER WALL OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945565 ↗MalfunctionApr 16, 2026Separation Problem
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS THAT THE STOPPED FALLS OFF DURING CENTRIFUGATION. THIS OCCURRED IN 100 DEVICES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900966 ↗MalfunctionApr 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 56 UNITS, FOREIGN MATTER WAS FOUND IN 154 TUBES AND THERE WAS 476 TUBES WITH AIR BUBBLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866838 ↗MalfunctionApr 9, 2026Premature Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 56 UNITS BLOOD COLLECTION TUBES, THE CAP OF ONE TUBE FELL OF RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835173 ↗MalfunctionApr 6, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 56 UNITS, FOREIGN MATTER WAS FOUND IN 300 TUBES AND AIR BUBBLES WERE IN 1600. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794084 ↗MalfunctionMar 26, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, FOREIGN MATTER WAS FOUND IN 207 TUBES AND AIR BUBBLES WERE SEEN IN 850 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24703313 ↗MalfunctionMar 23, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, 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 24666962 ↗MalfunctionMar 5, 2026Device Contamination with Chemical or Other Material
REPORT 1 OF 2: IT WAS REPORTED WHILE USING FOREIGN MATTER WAS SEEN INSIDE OF 15 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24526785 ↗MalfunctionMar 5, 2026Device Contamination with Chemical or Other Material
REPORT 2 OF 2. IT WAS REPORTED WHILE USING FOREIGN MATTER WAS SEEN INSIDE OF 44 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24526783 ↗MalfunctionFeb 24, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, 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 24434241 ↗MalfunctionFeb 11, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (N) 56 UNIT, ONE TUBE EXHIBITED FOREIGN MATTER (BLACK DOTS). NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314049 ↗
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- 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® 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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