Becton Dickinson & Co.: Medical Device Recall in 2025 - (Recall #: Z-0484-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

Product Classification:

Class II

Date Initiated: October 23, 2025
Date Posted: November 19, 2025
Recall Number: Z-0484-2026
Event ID: 97817
Reason for Recall:

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

Status: Ongoing
Product Quantity: 29,760 units
Code Information:

Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated