FDA Medical devices recall ·
BD EpiCenter Microbiology Data Management System… recall
- Recall number
- Z-0235-2026
- Date
- (initiated September 23, 2025)
- Company / brand
- Becton Dickinson & Co.
7 Loveton Cir, Sparks, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,050 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. Catalog Number: 441002; UDI/DI: 00382904410025; Serial Numbers: MXL8503690, 5xlz833, HCT26Q3, FB3D7F3, MY816005EF, EPSN0443, EPSN0445, EPSN0496, EPSN0500, 4WMW9R2, EPSN0509, EPSN0480, MXL8501ST4, 274kdz0276, 4CDFTJ1, 2PGX5V1, EPSN0484, EPSN0485, EPSN0486, EPSN0492, EPSN0494, EPSN0497, EPSN0498, EPSN0499, EPSN0462, EPSN0463, 5W5S252, 553H5M1, 9JG1M51, 9HB2H41, 4113NM1, 80KTQ02, 30KXLM1, EPSN0450, EPSN0451, EPSN0453, EPSN0456, EPSN0458, 550PS81, EPSN0466, EPSN0467, 8D00GY1, EPSN0469, EPSN0470, EPSN0471, EPSN0472, EPSN0474, 5TGRCP1, 5DSNS81, 4173NM1, H94Y7S1, CQZL2V1, 7ZFCPH1, H3VV7R1, 9OF0030, 107326, 107875, 107558, SNYHN1, 44YP282, 6CPBY02, EPSN0476, 2Y71FQ1, BRJ4197MTK, 5FCQ491, SNCB4Y7S1, 8S6Q2V1, JHL1ZD1, DZFCPH1, MXL7411G1W, F5S30B1, 8HR4W1, EPIDB6768, 11XTJQ1, EPISAM1, 3CR33002FV, JR5002013067, EPSN0510, EPSN0511, FT3841EPI, MXL5371H1F, MXL7411G1D, MXL7411G1Q, MXL7411G1N, MXL7191DW4, MLX7191DWQ, MLX7191DWW, MXL6191BM8, 48D2NM1, UB3788EPI5, MXL209140T, X1693649, EPSN0514, EPSN0516, EPSN0517, EPSN0520, EPSN0522, EPSN0523, EPSN0530, MXL72820P9, EPSN0532, EPSN0533, EPSN0534, EPSN0535, EPSN0536, EPSN0541, EPSN0543, EPSN0545, SAA70907WL, EPSN0558, EPSN0559, MXL922203Y, EPSN0560, EPSN0561, MXL9221PDD, EPSN0563, MXL9221PD3, EPSN0564, MXL9221PFW, EPSN0566, EPSN0567, EPSN0568, JR5002017009, 8CG927017D, 6ZNP1R1, MXL7520PM2, Epitraum, Epicenter PC Server, EPSN0550, EPSN0555, 9DK0C42, 5JWPCP1, EPSN0570, EPSN0572, 27PHT13, EPSN0573, EPSN0574, 46H8DH2, EPSN0575, MXL74413VS, EPSN0577
Distribution
Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.
States: Georgia Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0235-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.