Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 1+ years ago
Ortho-Clinical Diagnostics, Inc. Chemistry Products LAC Slides recall: VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure…
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Class II · 1+ years ago
C.R. Bard Inc SureStep Foley Tray System BARD¿ Lubri-Sil recall: Foley catheter trays have incorrect inserts, user may think:1)Silicone
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection…
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Class II · 1+ years ago
Folsom Metal Products, Inc. Frontier Devices, REF: 301.914S1 recall: Labeling includes shelf life that has not been validated
Labeling includes shelf life that has not been validated.
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Class II · 1+ years ago
Folsom Metal Products, Inc. Frontier Devices, REF: 301.914S2 recall: Labeling includes shelf life that has not been validated
Labeling includes shelf life that has not been validated.
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Class II · 1+ years ago
Beckman Coulter Inc. UniCel DxH 600 Coulter Cellular Analysis System recall: Hematology analyzers configured with HGB photometers may result
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood…
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Class II · 1+ years ago
Folsom Metal Products, Inc. Frontier Devices, REF: 301.912S2 recall: Labeling includes shelf life that has not been validated
Labeling includes shelf life that has not been validated.
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Class II · 1+ years ago
Beckman Coulter Inc. UniCel DxH 690T Coulter Cellular Analysis System recall: Hematology analyzers configured with HGB photometers may result
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood…
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Class II · 1+ years ago
Agilent Technologies Denmark ApS Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy recall: Their is the potential for weak staining which may result in false negative
Their is the potential for weak staining which may result in false negative CD20 identification.
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Class II · 1+ years ago
Ortho-Clinical Diagnostics, Inc. Vitros Chemistry Products LAC Slides recall: VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure…
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Class II · 1+ years ago
Abbott Point Of Care Inc. i-STAT CG8+ cartridge. List Number: 03P88-25. 510 numbers recall: Lack of a 510(k) premarket clearance for the i-STAT CG8+
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium…
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Class II · 1+ years ago
Medical Information Technology, Inc. Meditech Expanse Laboratory , Microbiology recall: Entering multiple keys that trigger input simultaneously may remove data
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
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Class II · 1+ years ago
Beckman Coulter Inc. UniCel DxH 900 Coulter Cellular Analysis System recall: Hematology analyzers configured with HGB photometers may result
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood…
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Class II · 1+ years ago
Folsom Metal Products, Inc. Frontier Devices, REF: 301.916S1 recall: Labeling includes shelf life that has not been validated
Labeling includes shelf life that has not been validated.
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Class II · 1+ years ago
Maquet Cardiovascular, LLC Heartstring III Proximal Seal System recall: Three failure modes have been identified: failure of the Heartstring Seal
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and…
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Class II · 1+ years ago
Agilent Technologies Denmark ApS Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy recall: Their is the potential for weak staining which may result in false negative
Their is the potential for weak staining which may result in false negative CD20 identification.
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Class II · 1+ years ago
Philips Medical Systems Inc Pinnacle Radiation Therapy Planning System: Multimodality recall: Due to a software issue, there is a potential image error of the Region
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…
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Class II · 1+ years ago
Boston Scientific Neuromodulation Corporation Vercise Deep Brain Stimulation Systems recall: Wire break(s) have occurred in rechargeable deep brain stimulation
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire…
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Class II · 1+ years ago
Exactech Equinoxe recall: Reverse Shoulder humeral liners have an articular surface position outside
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
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Class II · 1+ years ago
C.R. Bard Inc SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection recall: Foley catheter trays have incorrect inserts, user may think:1)Silicone
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection…
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Class II · 1+ years ago
C.R. Bard Inc SureStep Foley Tray System Bardex I.C. Complete Care Infection Control recall: Foley catheter trays have incorrect inserts, user may think:1)Silicone
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection…
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Class II · 1+ years ago
Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System recall: Hematology analyzers configured with HGB photometers may result
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood…
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Class II · 1+ years ago
Abbott Point Of Care Inc. i-STAT CG4+ cartridge . List Number: 03P85-25 recall: Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
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Class II · 1+ years ago
BigTree Sales Inc. The product is a handheld ultraviolet-C germicidal wand recall: The subject product emits unsafe level of UVC radiation (i.e
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…
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Class II · 1+ years ago
Folsom Metal Products, Inc. Frontier Devices, REF: 301.914S1 recall: Labeling includes shelf life that has not been validated
Labeling includes shelf life that has not been validated.