FDA Device recall Z-0591-2025
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150 by Becton Dickinson And, citing 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 ser….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0591-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-31 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Reason
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.
Identifiers
| code_info | Catalog No: 444150; UDI-DI: 00382904441500; Serial Numbers: JRPN215003AB, BTDN93800189, JRPN215003VS, BTDN938000WP, BTD…Catalog No: 444150; UDI-DI: 00382904441500; Serial Numbers: JRPN215003AB, BTDN93800189, JRPN215003VS, BTDN938000WP, BTDN938000XZ, BTDN93600B4R, BTDN0160058Z, BTDN939007WP, BTDN938000Z3, BTDN940003G5, BTDN932008FF, BTDN94000424, BTDN940003AV, BTDN938000WY, JRPN215003UA, JRPN215003M8, BTDN01800017, JRPN215003V7, BTDN934008WP, JRPN215003M4, BTDN939007Z9, JRPN2150038H, BTDN9380016F, BTDN938000WU, BTDN938001FL, JRPN215004L1, BTDN93600B0K, JRPN215003E8, BTDN934008S2, BTDN93600B3E, JRPN215004R7, JRPN215003CL, BTDN93600B5G, BTDN9200040Q, JRPN215004J9, JRPN21500418, BTDN934008UD, BTDN920003X8, JRPN215003JT, BTDN0180005Q, JRPN215003CZ, BTDN018000DT, JRPN215003CR, BTDN934008T2, JRPN215003M1, JRPN215003HR, JRPN215003TN, BTDN934008CE, BTDN932009P7, JRPN215003JG, JRPN215003X3, BTDN926003PU, BTDN928007ZA, BTDN926003UW, BTDN933008XS, BTDN9380014T, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0591-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.