HIGH

Becton Dickinson Recalls BD Phoenix M50 Due to Security Risk

Becton Dickinson & Co. recalled 4,283 BD Phoenix M50 Instruments on September 23, 2025. Unauthorized access to service credentials raises risks to data confidentiality and integrity. The recall affects devices distributed worldwide, including the U.S., Canada, and several countries across Europe and Asia.

Quick Facts at a Glance

Recall Date
September 23, 2025
Hazard Level
HIGH
Brand
Becton Dickinson
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Becton Dickinson & Co. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Product Details

The recalled models are BD Phoenix M50 Automated Microbiology Systems with catalog numbers 443624 and 44362409. These devices were distributed worldwide, including the U.S., Guam, and Puerto Rico. They were sold through multiple retailers.

The Hazard

The recall stems from unauthorized access to product service credentials. This breach could potentially compromise the confidentiality, integrity, and availability of the products and associated data.

Reported Incidents

No specific incidents of injury or data breach have been reported at this time. The risk remains due to potential unauthorized access.

What to Do

Stop using the BD Phoenix M50 Instrument immediately. Contact Becton Dickinson & Co. or your healthcare provider for further instructions and follow the recall procedures provided.

Contact Information

For more information, call Becton Dickinson & Co. or visit their website. Additional details can be found at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0239-2026.

Key Facts

  • Recalled on September 23, 2025
  • 4,283 units affected
  • Risk of unauthorized access to data
  • Devices distributed worldwide
  • Contact manufacturer for recall instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeAutomated Microbiology System
Sold At
Multiple Retailers

Product Details

Model Numbers
443624
44362409
UDI/DI: 00382904436247
PF4176
PF4182
+16 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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