FDA-Device2025-10-29Class IIPROCESSING DEFECT

BD Phoenix M50 Automated Microbiology System recalled for unauthorized access risk

OTHERNationwide distributionMedical devices

What this means

Unauthorized actors gained access to service credentials used by BD technical support teams to access the BD Phoenix M50 Automated Microbiology System. Until these credentials are updated, there is a risk that unauthorized individuals could access the system and view, modify, or disrupt patient data and system function.

Contact BD technical support to obtain updated service credentials
Change all service account passwords immediately
Review recent system access logs for suspicious activity
Monitor your system for any signs of unauthorized access

The agency's original wording

Hazard

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.

Affected count

4,283 units

Manufactured in

7 Loveton Cir, Sparks, MD, United States

Products

BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2026

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