BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II)Recalls & 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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2021 and Aug 25, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (33 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 22, 2018Class IITerminated
a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
Z-0528-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings33
- Device Markings/Labelling Problem17
- Contamination3
- Microbial Contamination of Device1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient1
BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) 221261CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL1 recall51 reports
- BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) 221239CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL3 reports
Recent BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436341 ↗MalfunctionJan 20, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) FOR PATIENT SAMPLE, THE CUSTOMER NOTICED CONTAMINATION WAS GROWING BENEATH THE AGAR. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115297 ↗MalfunctionDec 4, 2025Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BEFORE AND WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE CONTAMINATED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717779 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 15 OF 15 IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466780 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 13 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466242 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 14 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466241 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 11OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465927 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 12 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465918 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 10 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465558 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 8 OF 15 IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465557 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 9 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465556 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 6 OF 15 IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465418 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 4 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465083 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 7 OF 15: IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465079 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464865 ↗
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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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