Drug & Device Safety Atlas
Class II FDA device recall · Z-1026-2024

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 Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿

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. 230733¿¿ UDI-DI 00382902307334 Lots 1020750 1116997 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 2277205 3003821 3129527 3263117 9336993 0080290 0178844 0258758;  Catalog No. 231274¿ UDI-DI 30382902312742 Lots 2277205 3003821 3129527 3263117 0057245 0080290 1057453 1116997 1148461 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 9336993

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-1026-2024
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-1026-2024 · Source: openFDA enforcement.