FDA Device recall Z-1375-2025
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES D…
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES D… by Carefusion 303, citing sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive ti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1375-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-06 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
Reason
Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
Identifiers
| code_info | BD Pyxis Enterprise Server software versions: 1.7.4.128, 1.7.4.134, 1.7.4.136, 1.7.4.137, All 1.7.1, All 1.7.2, All 1.7…BD Pyxis Enterprise Server software versions: 1.7.4.128, 1.7.4.134, 1.7.4.136, 1.7.4.137, All 1.7.1, All 1.7.2, All 1.7.3. REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674, 1116-00/10885403512605 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1375-2025%22
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