Becton Dickinson & Co. BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
Lot Number/ Exp Date: 9269800 04/30/21, 9296589 05/31/21, 9317733 06/30/21, 9352487 07/31/21, Expanded 05/12/20- Lot Numbers: 9352484 07/31/21 9352492 07/31/21
Products Sold
Lot Number/ Exp Date: 9269800 04/30/21; 9296589 05/31/21; 9317733 06/30/21; 9352487 07/31/21; Expanded 05/12/20- Lot Numbers: 9352484 07/31/21 9352492 07/31/21
Becton Dickinson & Co. is recalling BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: due to May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
Recommended Action
Per FDA guidance
BD issued Urgent Medical Device Notification to Customers/Distributors on 4/14/20 via FedEX stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated above. Distributors requested to provide customer list to BD. BD will provide a product replacement for all discarded inventory. BD Customer/Technical Support 800-638-8663, Monday Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside the United States, contact your local BDrepresentative or distributor. On 5/12/20 firm expanded the recall to an additional six (6) lots of product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026