BD BBL Sensi Disc Ampicillin 2 ¿g — Class II medical device recall Z-0621-2025
Ongoing recall by Becton Dickinson & Co., reported 2024-12-11, distributed nationwide. BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to de
| Recall number | Z-0621-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-11-06 |
| Classified | 2024-12-05 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, MY, SG |
| Quantity | 13,190 units |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 30382902312636 |
| Lot numbers | 2339360, 3010977, 3058508, 3184064, 3234190 |
| Model numbers | 231263 |
Product
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263
Reason for recall
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
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-0621-2025. 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.