BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
FDA Device Recall #Z-0589-2025 — Class II — October 31, 2024
Recall Summary
| Recall Number | Z-0589-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 31, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Co. |
| Location | Sparks, MD |
| Product Type | Devices |
| Quantity | 70 units (7 US, 63 OUS) |
Product Description
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Reason for Recall
BD confirmed that 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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.
Lot / Code Information
Catalog No: 443990; UDI-DI: 00382904439903; Serial Numbers: CRG0023, CRG0041, CRG0115, CRG0040, CRG0106, CRG0110, CRG0112, CRG0109, CRG0047, CRG0120, CRG0039, CRG0113, CRG0035, CRG0037, CRG0036, VGT0009, CRG0020, CRG0002, VGX0004, CRG0007, CRG0008, CRG0104, CRG0018, CRG0019, CRG0045, CRG0029, CRG0028, CRG0030, CRG0201, CRG0203, CRG0021, CRG0004, CRG0005, CRG0006, CRG0009, CRG0010, CRG0012, CRG0011, CRG0013, CRG0014, CRG0025, CRG0015, CRG0016, CRG0017, CRG0026, CRG0027, CRG0107, CRG0101, CRG0105, CRG0108, CRG0114, CRG0116, CRG0117, CRG0119, CRG0118, CRG0034, CRG0044, CRG0001, CRG0003, CRG0032, CRG0038, CRG0043, CRG0042, CRG0102, CRG0111, CRG0048, CRG0103, CRG0121, CRG0204, CRG0207,
Other Recalls from Becton Dickinson & Co.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0484-2026 | Class II | BD Kiestra" Isolate Suspension Cuvette Array; ... | Oct 23, 2025 |
| Z-0237-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
| Z-0236-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
| Z-0240-2026 | Class II | BD Veritor Connect Software, labeled as the fol... | Sep 23, 2025 |
| Z-0235-2026 | Class II | BD EpiCenter Microbiology Data Management Syste... | Sep 23, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.