Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g — Class II medical device recall Z-1011-2024
Ongoing recall by Becton Dickinson & Co., reported 2024-02-14, distributed nationwide. There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (
| Recall number | Z-1011-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-01-08 |
| Classified | 2024-02-08 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 2,363,168 units |
| UPC / GTIN / UDI-DI | 00382902316282, 30382902316290 |
| Lot numbers | 2090490, 2146520, 2146526, 2147225, 2210201, 2224295, 2276143, 2276144, 3003894, 3062095, 3090649, 3163306, 3163307, 3163310, 3254307, 3254309, 3271840, 3271853 |
| Model numbers | 231628 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1011-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.