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Recall: BD Pyxis MedStation ES (FDA, 2023)

U.S. FDA — Device Enforcement published a recall for BD Pyxis MedStation ES (Med ES Main), REF 323 (CareFusion 303, Inc.). The firm initiated the recall…

[Recalled] BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 — Due to an automated dispensing cabinet software issue, when a medication single… | FDA 2023-04-05 — ref Z-0906-2025

FDA recall notice for BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 (CareFusion 303, Inc.). Reason: D

[Recalled] HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18 — A… | FDA 2026-09-23 — ref Z-0118-2027

FDA recall notice for HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and e

[Recalled] Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product… | FDA 2026-09-08 — ref Z-0089-2027

FDA recall notice for Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03

[Recalled] DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520 — Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical A… | FDA 2026-09-02 — ref Z-0084-2027

FDA recall notice for DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520 (Beckman Coulter Inc.). Reason: Bec

[Recalled] DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252… | FDA 2026-09-02 — ref Z-0083-2027

FDA recall notice for DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521

[Recalled] Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD… | FDA 2026-09-02 — ref Z-0081-2027

FDA recall notice for Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patr

[Recalled] Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0114-2027

FDA recall notice for Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V (Mindray DS USA, Inc.). Reason: Certain monitor operator's man

[Recalled] T1 Patient Monitor. Operator's Manual: T1 Patient Monitor — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0116-2027

FDA recall notice for T1 Patient Monitor. Operator's Manual: T1 Patient Monitor (Mindray DS USA, Inc.). Reason: Certain monitor operator's manuals contain descr

[Recalled] BeneView Series. Operator's Manuals: T5 / T8 — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0113-2027

FDA recall notice for BeneView Series. Operator's Manuals: T5 / T8 (Mindray DS USA, Inc.). Reason: Certain monitor operator's manuals contain descriptions that

[Recalled] cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0115-2027

FDA recall notice for cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 (Mindray DS USA, Inc.). Reason: Certain monitor operator's manuals contain des

[Recalled] BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0111-2027

FDA recall notice for BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 (Mindray DS USA, Inc.). Reason: Certain monitor operator's manuals cont

[Recalled] Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60). — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0112-2027

FDA recall notice for Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60). (Mindray DS USA, Inc.). Reason:

[Recalled] BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0110-2027

FDA recall notice for BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. (Mindray DS USA, Inc.). Reason: Certain monitor operator

[Recalled] VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 — Geobacillus stearothermophilus spore population in affected products may fall b… | FDA 2026-08-31 — ref Z-0075-2027

FDA recall notice for VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 (Steris Corporation). Reason: Geobacillus stearothermophilus spore populatio

[Recalled] ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A — Certain monitor operator's manuals contain descriptions that may be insufficien… | FDA 2026-08-31 — ref Z-0109-2027

FDA recall notice for ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A (Mindray DS USA, Inc.). Reason: Certain moni

[Recalled] VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 — Geobacillus stearothermophilus spore population in affected products may fall b… | FDA 2026-08-31 — ref Z-0071-2027

FDA recall notice for VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 (Steris Corporation). Reason: Geobacillus stearothermophilus spor

[Recalled] VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060 — Geobacillus stearothermophilus spore population in affected products may fall b… | FDA 2026-08-31 — ref Z-0072-2027

FDA recall notice for VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060 (Steris Corporation). Reason: Geobacillus stearothermo

[Recalled] VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061 — Geobacillus stearothermophilus spore population in affected products may fall b… | FDA 2026-08-31 — ref Z-0073-2027

FDA recall notice for VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061 (Steris Corporation). Reason: Geobacillus stearothermo

[Recalled] VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 — Geobacillus stearothermophilus spore population in affected products may fall b… | FDA 2026-08-31 — ref Z-0070-2027

FDA recall notice for VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 (Steris Corporation). Reason: Geobacillus stearothermophilus spor