Quick Facts at a Glance
- Recall Date
- September 23, 2025
- Hazard Level
- HIGH
- Brand
- BD
- 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
- Product type
- In Vitro Diagnostic System
- Model numbers
- 44191609, 441927, CT0883, CT0636, CT0462, CT0303, CT1217, CT0257 +12 more
- 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
BD MAX System is an automated in vitro diagnostic platform used in laboratories for molecular testing. It is distributed worldwide to healthcare facilities. The recall concerns cybersecurity and credential management rather than a physical hardware defect.
Why This Is Dangerous
Unauthorized access to service credentials could enable unauthorized actors to access or modify BD products and related data, potentially impacting patient data and system availability.
Industry Context
This recall is not described as part of a broader industry cybersecurity pattern in the provided information.
Real-World Impact
Labs may halt testing operations to secure credentials, review data, and implement updated credentials. There could be workflow disruption and data-access concerns until remediation steps are completed.
Practical Guidance
How to identify if yours is affected
- Identify if your facility uses BD MAX System units with catalog numbers 44191609 or 441927
- Cross-check the UDI/DI 00382904419165 if available
- Review recall notification for specific steps and contact BD through listed channels
- Audit access credentials and review security logs for evidence of unauthorized access
- Follow BD's instructions for credential updates and device remediation
Where to find product info
Recall notification channels include email, fax, letter, press release, telephone, or site visit from BD or healthcare provider
What timeline to expect
No specific remediation timeline is provided; recall is active with worldwide distribution
If the manufacturer is unresponsive
- Document all contact attempts with BD
- Escalate to facility leadership and pursue regulatory channels if necessary
- Maintain records of communications and device identifiers
How to prevent similar issues
- Strengthen credential management for service teams
- Regularly update access credentials and revoke unused accounts
- Monitor security notifications and apply updates promptly
- Educate staff on recognizing recall notices and escalation paths
Documentation advice
Keep the recall notice, device labels showing catalog numbers and UDI, correspondence with BD, and records of any remediation actions.
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Product Details
Catalog Numbers: 44191609; 441927. UDI/DI: 00382904419165. Sold worldwide to healthcare facilities. Date sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Catalog Numbers 44191609 and 441927
- Global distribution across many countries
- Hazard: unauthorized access to service credentials
- Recall status: ACTIVE (Class II)
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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