BD BBL™ Mueller Hinton II Agar 211438Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Mueller Hinton II Agar, 500 g · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382902114383), received between Mar 2, 2022 and Feb 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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, 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
- Incorrect, Inadequate or Imprecise Result or Readings2
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ MUELLER HINTON II AGAR THAT INSUFFICIENT AND HETEROGENOUS GROWTH OF AN UNSPECIFIED NUMBER OF PATIENT SAMPLES HAS BEEN OBSERVED ACROSS MULTIPLE BATCHES SINCE JULY 2024. THE CUSTOMER PREPARED THE DEHYDRATED CULTURE MEDIA BY STERILIZING THE BASE, ADDING 100ML OF HORSE BLOOD, ADDING 900 ML OF WATER, AND ADJUSTING THE PH TO 7.20±0.2. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21427239 ↗MalfunctionSep 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL MUELLER HINTON II AGAR THAT FALSE RESISTANCE WAS OBTAINED AN UNSPECIFIED NUMBER OF TIMES. HEAVY GROWTH UP TO THE SENSI DISK WAS OBSERVED WITH TRIMETHOPRIM-SULFAMETHOXAZOL AND A THIN HAZE OF GROWTH WAS OBSERVED WITH TRIMETHOPRIM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20250804 ↗MalfunctionMar 2, 2022Illegible Information; Illegible Information
IT WAS REPORTED WHILE TESTING WITH BD BBL¿ MUELLER HINTON II AGAR TWO LABEL WERE FOUND TO BE ILLEGIBLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON NOVEMBER 25, THE SUPROM CLIENT NOTIFIED A COMPLAINT, ABOUT THE RECEPTION OF THE PRODUCT WITH THE ILLEGIBLE LABEL, CATALOG: 211438, LOT: 1131296, 02 BOTTLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13654756 ↗
Other CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH devices
- NA CP114-10Remel, Inc. · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth1 recall0 reports
- BD BBL™ Mueller Hinton II Agar 221800Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH11 reports
- BD BBL™ Mueller Hinton II Agar 221275Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH3 reports
- BD BBL™ Mueller Hinton II Broth, Cation-Adjusted 212322Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH2 reports
- BD BBL™ Mueller Hinton II Agar 212257Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH1 report
- BD BBL™ Mueller Hinton II Agar 221177Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH1 report
- BD Difco™ Mueller Hinton Agar 225250Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH1 report
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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