BD Gram Stain Kit — Class II medical device recall Z-2031-2012
Terminated recall by Becton Dickinson & Co., reported 2012-07-25, distributed nationwide. Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & mor
| Recall number | Z-2031-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2012-04-12 |
| Classified | 2012-07-18 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2012-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 539 kits |
| Lot numbers | 1348873 |
| Expiration dates | 2013-04-30 |
Product
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Reason for recall
Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
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-2031-2012. 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.