BD BBL™ Hektoen Enteric Agar 221366Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Hektoen Enteric Agar · Class 1
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 10382902213663), received between Oct 3, 2022 and Nov 7, 2022 — 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.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
- Contamination1
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.
MalfunctionNov 7, 2022Contamination; Contamination
IT WAS REPORTED THAT WHILE USING BD BBL¿ HEKTOEN ENTERIC AGAR CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES MEDIA IS CONTAMINATED WITH PSEUDOMONAS FLUORESCENCE HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS,"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15749880 ↗MalfunctionOct 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ HEKTOEN ENTERIC AGAR CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER UNPACKING, BACTERIA HAVE GROWN IN THE MEDIUM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677037 ↗MalfunctionOct 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ HEKTOEN ENTERIC AGAR WAS CONTAMINATED UPON ARRIVAL. THE CONTAMINATION APPEARS TO BE BIOLOGICAL GROWTH. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATION UPON ARRIVAL. THE CONTAMINATION APPEARS TO BE BIOLOGICAL GROWTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15531491 ↗
Other CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL devices
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- CHROMID® C. difficileBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL1 recall3 reports
- REMEL R02049Remel, Inc. · Culture Media, Selective And Differential1 recall0 reports
- Strep Selective II Agar R01859Remel, Inc. · Culture Media, Selective And Differential1 recall0 reports
- BD BBL™ CHROMagar™ Candida 254093Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL29 reports
- CHROMID® S. aureus Elite agarBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL9 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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