Recall Z-0237-2026
Becton Dickinson & Co. · initiated September 23, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
Codes / lots: 1. Catalog Number, (Serial Numbers): 445570, UDI/DI: 00382904455705 (UB4523, UB3416, UB3975, UB3871A, UB3753, UB4823, DB2572, UB4642, UB3414, UM1431, UB3731, UB1470, UB5555, UM1395, UB4212, UB3555, UB4159, UB4778, UB3805, UB1648, UB4562, UB4174, UB4325, UB1801, UB5086, UB1990, UB3103, UB4274, UB4360, UB1611, UB4535, UB4542, UB4596, UB3338, UB4688, UB3480, UB4928, UB4929, UB1439, UB1583, UB5178, UB3122, UB3335, UB3229, UB4005, UB1682, UB3541, UB3193, UB4184, UB1778, UB4405, UB3413, UB4271, UB4715, UB3210, UB4110, UB4112, UB3499, UB5405, UB5389, UB5442, UB5362, UB4995, UB1812, UB4427, UB4253, UB1708, UB3273, UM1273, UB4959, US1103, UB3383, UM1283, UM1269, UB5663, UB4384, UB5569, UB5470, UB5594, UB4185, UB5679, UB5527, UB5361, UB5579, UB4280, UB5535, UB4221, UB5596, UB5576, UB5588, UB5496, UB5610, UB3242, UB5537, UB5553, UB5565, UB5451, UB5505, UB5492, UB5507, UB5526, UB5691, UB5693, UB5694, UB5456, UB5609, UB5534, UB5631, UB5469, UB5541, UB3647, UB4048, UB4177, UB5415, UB5080, UB5529, UB5587, UB3398, UB5584, UB5414, UB5444, UB5474, UB5495, UB5523, UB5503, UB5431, UB3814, UB5550, UB5559, UB4661, UB5073, UB4776, UB5074, UB5059, UB5380, UB3491, UB4922, UB1862, UB4881, UB5093, UB2082…
Reason for recall
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.
FDA-determined cause: Software design
Action taken
Beckton, Dickenson and Company notified consignees on about 09/23/2025 via mailed letter and email. This updated letter serves as a supplement to the original field action communication, dated 10/31/2024. It is intended to clarify that the previously described issue remains unchanged; however, the scope of the impacted product SKUs has been expanded. The update specifically documents additional SKUs including refurbished product codes that were not included in the original communication. Consignees were instructed to follow outlined best practices for maintaining strong security measures to protect hospital networks and medical devices, read and understand the recall notification, provide the letter to all applicable personnel or customers if further distributed, and complete and return the Customer Response Form.
Details
- Recall number
- Z-0237-2026
- Initiated
- September 23, 2025
- Posted by FDA
- October 23, 2025
- Product code
- MDB – System, Blood Culturing
- Quantity
- 1,086 units
- 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…
- Recalling firm
- Becton Dickinson & Co., Sparks, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0235-2026 Class II | BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0236-2026 Class II | BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0238-2026 Class II | BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0239-2026 Class II | BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0240-2026 Class II | BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number:…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |