BD BACTEC™ Plus Aerobic/F Culture Vials 442023Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ Plus Aerobic/F Medium · Class 1
All models of BD BACTEC Plus Aerobic/F Culture Vials (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC Plus Aerobic/F culture vial is the subject of 1,060 adverse event reports, which mention 2 deaths and 46 injuries. Most reports describe false positive results, along with inaccurate results, contamination of samples, and blood leaking from bottles. Reports fell from 173 in the previous 12 months to 18 in the latest 12 months. No recalls name this device.
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
- 1,063
- Deaths reported
- 2
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,063 adverse event reports that list this exact device (DI 00382904420239), received between Feb 12, 2018 and Jul 31, 2026 — classified as 2 deaths, 46 injuries, 1,015 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (640 reports).
1 other recall cover devices cleared under the same FDA submission (K113558, K222591); 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result640
- Incorrect, Inadequate or Imprecise Result or Readings272
- Contamination105
- Leak/Splash25
- Device Markings/Labelling Problem22
- False Negative Result22
- Contamination of Device Ingredient or Reagent14
- Inaccurate Information5
Patient problems
- No Clinical Signs, Symptoms or Conditions1,032
- No Consequences Or Impact To Patient27
- Insufficient Information15
- Bacterial Infection6
- Misdiagnosis4
- Blister1
- Death1
- Fungus1
Recent adverse event reports
The 25 most recent of 1,063 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098303 ↗MalfunctionJul 31, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098300 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085773 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085765 ↗MalfunctionJun 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS SPHINGOMONAS PAUCIMOBILIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443399 ↗MalfunctionJun 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS SPHINGOMONAS PAUCIMOBILIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443384 ↗MalfunctionJun 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS SPHINGOMONAS PAUCIMOBILIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443375 ↗MalfunctionJun 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS SPHINGOMONAS PAUCIMOBILIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25432232 ↗MalfunctionJun 8, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25432213 ↗MalfunctionMay 27, 2026Leak/Splash
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302456 ↗MalfunctionApr 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS MISASSOCIATION OF ONE PATIENT SAMPLE NUMBER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944377 ↗MalfunctionFeb 19, 2026Leak/Splash
REPORT 4: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24391009 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS BACILLUS CEREUS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390997 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390996 ↗MalfunctionFeb 19, 2026Leak/Splash
REPORT 3: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390995 ↗MalfunctionFeb 5, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24271944 ↗MalfunctionJan 27, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189673 ↗MalfunctionNov 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE LABEL INFORMATION LISTED ON ONE BOTTLE WAS INCORRECT AND INCLUDED TWO LABELS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543436 ↗MalfunctionNov 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23533305 ↗MalfunctionNov 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS NO GROWTH OF HELICOBACTER CINAEDI SEEN IN ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485007 ↗MalfunctionNov 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482887 ↗MalfunctionOct 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PART 3 OF 3: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS BC BY ENVIRONMENTAL BACTERIA - PENICILLIUMS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312281 ↗MalfunctionOct 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PART 2 OF 3: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS BC BY ENVIRONMENTAL BACTERIA - PENICILLIUMS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312278 ↗MalfunctionOct 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PART 1 OF 3: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS BC BY ENVIRONMENTAL BACTERIA - PENICILLIUMS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312235 ↗MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 3: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS BACILLUS CEREUS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293475 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K113558, K222591. One submission often covers many models, so check the product and lot details in each record.
- Z-0110-2024 · Sep 12, 2023 · Open, ClassifiedBD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Other SYSTEM, BLOOD CULTURING devices
- BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1,472 reports
- BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials 442021Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1 death791 reports
- BD BACTEC™ FX Top 441385Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 recalls1 death475 reports
- BD BACTEC™ Peds Plus™/F Culture Vials 442020Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING355 reports
- BD BACTEC™ Plus Anaerobic/F Culture Vials 442022Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING237 reports
- BD BACTEC™ MGIT™ 960 Instrument 445870Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING186 reports
- BACT/ALERT® FA PLUSBiomerieux , Inc. · System, blood culturing1 recall126 reports
- BACT/ALERT® PF PLUSBiomerieux , Inc. · System, blood culturing1 recall124 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
- 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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