BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Reported: December 11, 2024 Initiated: October 31, 2024 #Z-0590-2025
Product Description
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Reason for Recall
BD confirmed that 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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 2,537 units (876 US, 1,661 OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916. Recalled by Becton Dickinson & Co.. Units affected: 2,537 units (876 US, 1,661 OUS).
Why was this product recalled? ▼
BD confirmed that 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0590-2025.
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