BD Vacutainer® FX 10mg 8mg Blood Collection Tubes 368921Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 30382903689218), received between Nov 17, 2023 and Mar 30, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K901449); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Short Fill

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® FX 10MG 8MG 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 24737434 ↗
• MalfunctionMar 30, 2026Short Fill

  REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® FX 10MG 8MG 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 24736708 ↗
• MalfunctionFeb 18, 2026Device Ingredient or Reagent Problem; Improper Chemical Reaction

  REPORT 1 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® FX 10MG 8MG BLOOD COLLECTION TUBES, HEMOLYSIS WAS SEEN WITH ONE SAMPLE AFTER CENTRIFUGATION AND AN UNSPECIFIED NUMBER OF TUBES SHOWED ADDITIVE ABNORMALITY WHERE THE POWDER DID NOT COAT THE ENTIRE TUBE WALL BUT RATHER APPEARED CLUMPY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377628 ↗
• MalfunctionFeb 18, 2026Device Ingredient or Reagent Problem; Improper Chemical Reaction

  REPORT 2 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® FX 10MG 8MG BLOOD COLLECTION TUBES, HEMOLYSIS WAS SEEN WITH TWO SAMPLE FROM THE SAME PATIENT AFTER CENTRIFUGATION AND AN UNSPECIFIED NUMBER OF TUBES SHOWED ADDITIVE ABNORMALITY WHERE THE POWDER DID NOT COAT THE ENTIRE TUBE WALL BUT RATHER APPEARED CLUMPY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377618 ↗
• MalfunctionFeb 18, 2026Device Ingredient or Reagent Problem

  REPORT 3 OF 3. IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® FX 10MG 8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES SHOWED ADDITIVE ABNORMALITY WHERE THE POWDER DID NOT COAT THE ENTIRE TUBE WALL BUT RATHER APPEARED CLUMPY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377615 ↗
• MalfunctionOct 15, 2025Clumping in Device or Device Ingredient; Improper Chemical Reaction; Clumping in Device or Device Ingredient; Improper Chemical Reaction

  IT WAS REPORTED WHILE USING BD VACUTAINER® FX 10MG 8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE FOUND TO BE COAGULATED AND HAD BLOOD DEPOSITS ON THE WALLS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291652 ↗
• MalfunctionJun 11, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® FX 10MG 8MG 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 22183870 ↗
• MalfunctionJun 9, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® FX 10MG 8MG 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 22168791 ↗
• MalfunctionApr 5, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT THE BD VACUTAINER® FX 10MG 8MG PLUS BLOOD COLLECTION TUBES HAD BLOOD POOLING IN THE STOPPER. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050206 ↗
• MalfunctionMar 25, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 10MG 8MG PLUS BLOOD COLLECTION TUBES THE CUSTOMER FOUND WHITE POWDER IN THE TUBE. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969924 ↗
• MalfunctionFeb 1, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 10MG 8MG PLUS BLOOD COLLECTION TUBES THERE WAS AN ABNORMAL ADDITIVE FORM. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622004 ↗
• MalfunctionJan 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 10MG 8MG PLUS BLOOD COLLECTION TUBES, ONE TUBE EXPERIENCES CLUMPED/ABNORMAL ADDITIVE FORM. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608290 ↗
• MalfunctionJan 30, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 10MG 8MG PLUS BLOOD COLLECTION TUBES THERE WAS ONE TUBE WITH DISCOLORED/ABNORMAL ADDITIVE FORM. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607571 ↗
• MalfunctionNov 17, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 10MG 8MG PLUS BLOOD COLLECTION TUBES NOTED ON ONE TYPE OF TUBE IN PARTICULAR DURING UNBLOCKING, THE TUBE IS TIGHT IN HOLDER. THIS EVENT OCCURRED 39 TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159743 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K901449. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
• Z-2309-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
• Z-2296-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
• Z-2297-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
• Z-2298-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
• Z-2299-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884