Food, drugs, devices › Becton Dickinson & Co.
Device recall: BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Becton Dickinson & Co. (Sparks, MD) initiated this device recall on 31 Oct 2024; FDA lists 13 product records under event 95636, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Becton Dickinson & Co. has 77 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Becton Dickinson & Co., Sparks, MD.
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
"Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0584-2025 | BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007 | Software | Class II | Ongoing | 11 Dec 2024 |
| Z-0585-2025 | BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887 | 7,974 units (2,517 US, 5,457 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0586-2025 | BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981 | 7,974 units (2,517 US, 5,457 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0587-2025 | BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988 | 66 units (18 US, 48 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0588-2025 | BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989 | 18 units (12 US, 6 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0589-2025 | BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990 | 70 units (7 US, 63 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0590-2025 | BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916 | 2,537 units (876 US, 1,661 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0591-2025 | BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150 | 56 units (OUS only) | Class II | Ongoing | 11 Dec 2024 |
| Z-0592-2025 | BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624 | 4,411 units (567 US, 3,844 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0593-2025 | BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385 | 10,129 units (2,836 US, 7,293 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0594-2025 | BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 | 8,085 units (838 US, 7,247 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0595-2025 | BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 | 1,087 units (136 US, 951 OUS) | Class II | Ongoing | 11 Dec 2024 |
| Z-0596-2025 | BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 | 584 units (313 US, 271 OUS) | Class II | Ongoing | 11 Dec 2024 |
Context
Other enforcement events for Becton Dickinson & Co.
All 77 events for Becton Dickinson & Co.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.