Becton Dickinson & Co.: Device Recall

Recall Details

Recall Number

Z-0621-2025

Classification

Class II

Product Type

Device

Recalling Firm

Becton Dickinson & Co.

Status

Ongoing

Date Initiated

11/06/2024

Location

Sparks, MD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

13,190 units

Reason for Recall

BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility

Product Description

BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NE, PA and the countries of Canada, Belgium, Singapore, Malaysia.

Other Recalls by Becton Dickinson & Co.

• Class II: Risk 10/23/2025
  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.
• Class II: Risk 09/23/2025
  Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
• Class II: Risk 09/23/2025
  Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
• Class II: Risk 09/23/2025
  Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
• Class II: Risk 09/23/2025
  Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

View all recalls by Becton Dickinson & Co. →