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Optima Coil System (Balt USA) – Radiopaque Marker Issue (2025)

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

High

FDAMay 8, 2025Nationwide• BALT USA, LLC

Zen-O Lite Oxygen Concentrator (Ohio Medical) – Calibration Error (2025)

Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

Moderate

FDAMay 8, 2025Nationwide• Ohio Medical Corporation

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Optima Coil System (Balt USA) – Radiopaque Marker Issue (2025)

Zen-O Lite Oxygen Concentrator (Ohio Medical) – Calibration Error (2025)

Prestige Coil System (Balt USA) – Radiopaque Marker Issue (2025)

Z-800WF Infusion System (Zyno Medical) – Unreleased Software (2025)

OBM00002 OBM DAB (XLTEK) – Backwards Electrode Labels (2025)

Z-800 Infusion System (Zyno Medical) – Unreleased Software (2025)

SmartRelease ESTR (MicroAire) – Unintended Blade Cut (2025)

Valeda Light System (Lumithera) – Configuration Error (2025)

DxI 9000 Access Analyzer (Beckman Coulter) – Calibration Issues (2025)

Z-800W Infusion System (Zyno Medical) – Unreleased Software (2025)

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

Z-800F Infusion System (Zyno Medical) – Unreleased Software (2025)

Affinity 4 Birthing Bed (Baxter) – Signal Wire Crimp (2025)

PhenoMATRIX (Copan) – Unapproved Software (2025)

HardyCHROM CRE (Hardy Diagnostics) – Quality Control Failure (2025)

Powered Laser Surgical Instrument (Olympus) – Thermal Incident Risk (2025)

Access Testosterone Assay (Beckman Coulter) – Maintenance Error (2025)

SAFE-T-FILL Capillary (ASP Global) – False Positive Results (2025)

Dexcom G7 iOS App (Dexcom) – Glucose Value Bug (2025)

EVIS EXERA III Duodenovideoscope (Olympus) – Contamination Risk (2025)