Quick Facts at a Glance
- Recall Date
- September 23, 2025
- Hazard Level
- HIGH
- Brand
- BD
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Blood Culture System
- Model numbers
- 445570, 445702, 44557008, UB4523, UB3416, UB3975, UB3871A, UB3753 +13 more
- Sold at
- Multiple Retailers
- 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 used in clinical laboratories to detect bloodstream infections by incubating blood culture bottles and signaling growth. It is deployed across hospitals and healthcare facilities to guide sepsis diagnosis.
Why This Is Dangerous
The recall is prompted by unauthorized access to product service credentials. If exploited, this could allow access to device software or data, potentially compromising patient data and system availability.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Hospitals may experience downtime or need to implement additional cybersecurity controls while awaiting remediation. There is potential for data exposure related to device service credentials.
Practical Guidance
How to identify if yours is affected
- Check device label for catalog numbers 445570, 445702, 44557008
- Review serial numbers listed (e.g., 445570) and the UDI/DI: 00382904455705
- Cross-check with the recall notice and FDA enforcement page to verify status
Where to find product info
FDA enforcement page and BD’s official recall notices
What timeline to expect
Remediation and replacement processes typically take weeks to months, depending on BD’s remediation plan and facility needs
If the manufacturer is unresponsive
- Document all communications with BD
- Escalate to your hospital’s risk management or biosafety officer
- If needed, contact the FDA for guidance on unresponsive manufacturers
How to prevent similar issues
- Limit access to device service credentials; enforce strong authentication and access controls
- Keep device firmware and software up to date per vendor guidance
- Verify vendor communications through official channels before acting
- Maintain an inventory of affected devices and monitor for updates
Documentation advice
Save all recall notices, emails, and vendor communications; photograph labels and serials; log dates and actions taken
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Product Details
Product: BD BACTEC Blood Culture System. Catalog numbers: 445570, 445702, 44557008. Serial numbers include 445570. UDI/DI: 00382904455705 (UB4523 UB3416 UB3975 UB3871A UB3753 UB4823 DB2572 UB4642 UB3414 UM1431 UB3731 UB1470 UB5555 UM1395 UB4212 UB3555 UB4159 UB4778). Distribution: Worldwide. Quantity: 1,086 units. Recall date: 2025-09-23.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recall notice issued 2025-09-23
- No injuries reported
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