Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
Why it was recalled
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Catalog No. 230998 UDI-DI 00382902309987 Lots 1242880 1277918 1301570 2025088 2056233 2118569 2276681 3094187 3212760 3263267 9009914 9046895 0065366 0178210; Catalog No. 231344¿ UDI-DI 30382902313442 Lots 3010027 3062263 3094187 3158029 3212760 3263267 3275644 0065366 0085202 0230453 0274792 0335906 1095603 1148539 1180271 1242880 1277918 1301570 2025088 2056233 2089874 2118569 2276681 8355562 9009914 9046895 9130797 9239639 9263061
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Domestic distribution nationwide. International distribution worldwide.
Recall record
- Recalling firm
- Becton Dickinson & Co.
- Product type
- Devices
- Recall number
- Z-1040-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Sparks, MD
- Recall initiated
- 2024-01-08
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1040-2024 · Source: openFDA enforcement.