Quick Facts at a Glance
- Recall Date
- September 23, 2025
- Hazard Level
- HIGH
- Brands
- BD, BD (Becton Dickinson)
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BD, BD (Becton Dickinson)
- Product type
- Blood Culture System
- Model numbers
- 44138509, 441676, 445569, 44229609
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 23, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The BD BACTEC Blood Culture System is an automated platform used in hospitals to analyze blood samples for bloodstream infections. It is deployed in clinical laboratories for routine diagnostic work.
Why This Is Dangerous
Cybersecurity vulnerabilities in lab equipment can expose patient data and affect device availability and integrity. Unauthorized access could disrupt operations or expose sensitive information.
Industry Context
This recall aligns with growing concerns about cybersecurity in medical devices.
Real-World Impact
Hospitals may need to suspend or modify testing workflows to apply updates. Potential downtime could affect turnaround times for critical diagnoses and patient care.
Practical Guidance
How to identify if yours is affected
- Confirm recall status with your biomedical team
Where to find product info
BD recall notices and guidance can be found at the BD official website and the FDA enforcement report page linked in the recall notice
What timeline to expect
Remediation and replacement steps will be scheduled by BD with hospitals; typical timelines vary by facility.
If the manufacturer is unresponsive
- Escalate to BD corporate office if assigned technicians are not responsive
- Contact local regulatory bodies if patient data exposure is suspected
How to prevent similar issues
- Strengthen access controls for service accounts
- Regularly review vendor credential access
- Monitor for unusual activity on connected devices
- Keep firmware and software updated per BD guidance
Documentation advice
Keep copies of the recall notice, correspondence with BD, inventory lists of affected catalog/serial numbers, and records of credential updates.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Numbers: 44138509; 441676; 445569; 44229609. Serial numbers include FT5675, FT5497, FT4948, FT5781, FT5120, FT3993, FT7779, FT3387, FT1993, FT5019, FT9109, FT8412, FT7176, FT7344, FT4282, FT7400, FT6093, FT0962. UDI/DI: 00382904413859. Sold worldwide to healthcare facilities. Recall Date: 2025-09-23. Status: Active. Quantity: 177 units. Distribution: Worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution to healthcare facilities
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.