BD BACTEC Peds Plus/F Culture VialsRecalls & reported problems across all models
Becton, Dickinson And Company · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 366
- Deaths reported
- 2
- Injuries reported
- 12
- Recalls
- 0
We found 2 models of BD BACTEC Peds Plus/F Culture Vials by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 366 adverse event reports in the FDA's MAUDE database, received between May 14, 2018 and Aug 24, 2026 — classified as 2 deaths, 12 injuries, 352 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (206 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD BACTEC Peds Plus/F Culture Vials problems
Device problems
- False Positive Result206
- Incorrect, Inadequate or Imprecise Result or Readings71
- Contamination61
- False Negative Result12
- Device Markings/Labelling Problem10
- Contamination of Device Ingredient or Reagent3
- Adverse Event Without Identified Device or Use Problem2
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions345
- No Consequences Or Impact To Patient18
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Death2
- Bacterial Infection1
- Exposure to Body Fluids1
- Local Reaction1
BD BACTEC Peds Plus/F Culture Vials models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD BACTEC™ Peds Plus™/F Culture Vials 442020SYSTEM, BLOOD CULTURING355 reports
- BD BACTEC™ Peds Plus™/ F Culture Vials 442194SYSTEM, BLOOD CULTURING2 deaths11 reports
Recent BD BACTEC Peds Plus/F Culture Vials adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408870 ↗MalfunctionAug 21, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379903 ↗MalfunctionAug 18, 2026False Negative Result
It was reported while using BD BACTEC¿ Peds Plus¿/ 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 50303791 ↗MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS NIALLIA CIRCULANS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343810 ↗MalfunctionFeb 16, 2026Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THE LABEL INFORMATION LISTED ON ONE BOTTLE WAS INCORRECT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343807 ↗MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS NIALLIA CIRCULANS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343800 ↗MalfunctionJan 14, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ 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 24067281 ↗MalfunctionNov 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS CANDIDA PARAPSILOSIS . NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532507 ↗MalfunctionNov 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS CANDIDA PARAPSILOSIS . NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532503 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976657 ↗MalfunctionSep 5, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975204 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960993 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960991 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960989 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960987 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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