Class IIOngoingZ-2576-2025
Folsom Metal Products, Inc. recalls Frontier Devices
Labeling includes shelf life that has not been validated.
Folsom Metal Products,…ALSep 24, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,045–1,056 of 2,908 recalls
Class IIOngoingZ-2575-2025
Beckman Coulter Inc. recalls UniCel DxH 600 COULTER Cellular Analysis System
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Beckman Coulter Inc.CASep 24, 2025
Class IIOngoingZ-2574-2025
Beckman Coulter Inc. recalls UniCel DxH 800 COULTER Cellular Analysis System
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Beckman Coulter Inc.CASep 24, 2025
Class IIOngoingZ-2573-2025
Beckman Coulter Inc. recalls UniCel DxH 690T COULTER Cellular Analysis System
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Beckman Coulter Inc.CASep 24, 2025
Class IIOngoingZ-2572-2025
Beckman Coulter Inc. recalls UniCel DxH 900 COULTER Cellular Analysis System
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Beckman Coulter Inc.CASep 24, 2025
Class IIOngoingZ-2571-2025
BigTree Sales Inc. recalls The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter
The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes).…
BigTree Sales Inc.CASep 24, 2025
Class IIOngoingZ-2570-2025
Philips Medical Systems (Cleveland) Inc recalls Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.…
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Philips Medical System…FLSep 24, 2025
Class IIOngoingZ-2569-2025
Medical Information Technology, Inc. recalls MEDITECH Expanse Laboratory (LAB)
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Medical Information Te…MASep 24, 2025
Class IIOngoingZ-2565-2025
Agilent Technologies Denmark ApS recalls Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy
Their is the potential for weak staining which may result in false negative CD20 identification.
Agilent Technologies D…Sep 24, 2025
Class IIOngoingZ-2564-2025
Agilent Technologies Denmark ApS recalls Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy
Their is the potential for weak staining which may result in false negative CD20 identification.
Agilent Technologies D…Sep 24, 2025
Class IIOngoingZ-2563-2025
Agilent Technologies Denmark ApS recalls Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy
Their is the potential for weak staining which may result in false negative CD20 identification.
Agilent Technologies D…Sep 24, 2025
Class IIOngoingZ-2562-2025
Exactech, Inc. recalls Exactech Equinoxe
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Exactech, Inc.FLSep 24, 2025