FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
- Recall number
- Z-2047-2020
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
- Status
- Terminated
- Initiated
- 2020-04-14
- Posted
- not on file
- Terminated
- 2022-02-10
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 236 bottles
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
- Lot, serial or model codes
- Lot Number/ Exp Date: 317740 06/30/21; 9296637 05/31/21. Expanded 5/12/20 Lot numbers:: 9296631 05/31/21; 0027824 08/31/21.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTS
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28