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, PREGNANT
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
- Automated Microbiology Instrument
- Model numbers
- 443624, 44362409, PF4176, PF4182, PF2302, PF4198, PF4149, PF4189 +12 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 Phoenix M50 Automated Microbiology System is used in clinical laboratories to identify and test pathogens. It is part of automated workflows in microbiology labs and supports patient diagnostic processes.
Why This Is Dangerous
BD notes an unauthorized actor accessed product service credentials. This could lead to unauthorized access to device software or data, affecting confidentiality, integrity and availability of the systems and related information.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Labs may need to pause some operations to implement remediation. The recall may affect data security, system availability and workflow continuity in clinical labs.
Practical Guidance
How to identify if yours is affected
- Check device label for Catalog Numbers 443624 or 44362409
- Verify UDI 00382904436247 on the device or packaging
- Cross-check with BD recall Z-0239-2026 notice
Where to find product info
Official recall notices on the FDA Enforcement Report page and BD’s recall communications page
What timeline to expect
Remediation timelines are determined by BD; typical replacement or remediation processes may take 4-6 weeks once initiated
If the manufacturer is unresponsive
- Document all attempts to contact BD
- Escalate to hospital risk management or regulatory authorities if BD is not responsive
- Consider filing a complaint with the FDA if appropriate
How to prevent similar issues
- Review and tighten access controls for service credentials
- Ensure only authorized BD personnel have credentials
- Monitor for unauthorized access attempts and security advisories from BD
Documentation advice
Retain the recall notice, serial numbers, UDI, and all correspondence with BD for records.
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Product Details
Catalog Numbers: 443624, 44362409. Product: BD Phoenix M50 Automated Microbiology System. UDI/DI: 00382904436247. PF family models include PF4176, PF4182, PF2302, PF4198, PF4149, PF4189, PF4202, PF2699, PF4200, PF4207, PF4209, PF2640, PF2769, PF3383, PF2742, PF4215, PF4204, PF0571. Distribution: Worldwide. Sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Catalog numbers 443624 and 44362409
- Recall number Z-0239-2026
- Classification: Class II
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Safety Guide
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