Becton Dickinson & Co.: Medical Device Recall in 2020 - (Recall #: Z-2048-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

Product Classification:

Class II

Date Initiated: April 14, 2020

Date Posted: May 27, 2020

Recall Number: Z-2048-2020

Event ID: 85508

Reason for Recall:

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

Status: Terminated

Product Quantity: 1469 kits

Code Information:

Lot Number/ Exp Date: 0007261 06/30/21; 0007255 05/31/21; 0028309 03/30/21. Expanded 5/12/20-Lot Numbers/Exp. Date: 0041114 07/31/21; 0014322 06/30/21

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated