Becton Dickinson & Co.: Medical Device Recall in 2024 - (Recall #: Z-1011-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing

Product Classification:

Class II

Date Initiated: January 8, 2024
Date Posted: February 14, 2024
Recall Number: Z-1011-2024
Event ID: 93789
Reason for Recall:

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.

Status: Ongoing
Product Quantity: 2,363,168 total units
Code Information:

Catalog No. 231628 UDI-DI 00382902316282 Lots 2090490 2146520 2210201 2276143 3062095; Catalog No. 231629¿¿ UDI-DI 30382902316290 Lots 3163306 3163307 3163310 3254307 3254309 3271840 3271853 2146520 2146526 2147225 2210201 2224295 2276143 2276144 3003894 3062095 3090649

Distribution Pattern:

Domestic distribution nationwide. International distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated