BD Sensi Disc Cefpodoxime Antibiotic Testing Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc Cefpodoxime testing discs due to potential accuracy failures in antibiotic susceptibility testing. The defect may cause inaccurate results, delayed diagnosis, or inappropriate antibiotic selection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a possibility of accuracy failures in diagnostic testing, which may lead to delayed diagnosis or inappropriate antibiotic selection, placing it under the rubric category of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
BD BBL Sensi Disc Cefpodoxime 10 microgram discs are used in laboratories for antibiotic susceptibility testing. The FDA has issued a Class II recall for 2,363,168 units because of potential quality control and accuracy failures.
According to the manufacturer, failures in test reproducibility and accuracy may cause laboratory test results to be discarded, delayed, or inaccurate. This can lead to delayed diagnosis, inappropriate antibiotic selection for patient treatment, or extended inappropriate antibiotic exposure.
The affected discs were distributed nationwide in the United States and internationally. Affected lot numbers include 3109152, 3157106, and 3241174 (Catalog Nos. 231673 and 231674). Laboratories using these products should verify lot numbers and contact Becton Dickinson & Co. for guidance.
The recalled product
- Product
- BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- accuracy-failure
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog No. 231673 UDI-DI 00382902316732 Lots 3109152 3157106 3241174
- Catalog No. 231674 UDI-DI 30382902316740 Lots 3157106 3241174 3109152
Distribution
Distributed nationwide across the United States.
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