Latest recalls — page 14
Older notices, newest first.
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Class II · 26 days ago
Philips North America Llc SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Philips North America Llc Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Medline Convenience Kits: 1) MFC Craniotomy Pack recall: The kits contain neurological sponges with the potential for unexpected
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may…
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Class II · 26 days ago
Baxter Healthcare Corporation PRO+ 36" MRS Surface recall: There is an error in the product description on the Unique Device
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the…
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Class II · 26 days ago
Baxter Healthcare Corporation PRO+ MRS Surface FOR Versacare recall: There is an error in the product description on the Unique Device
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the…
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Class II · 26 days ago
Baxter Healthcare Corporation Brand Name: Volara System Product Name: Volara, HC recall: Contamination within the release test equipment flow path could have affected
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to…
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Class II · 26 days ago
Becton, Dickinson and Company ForeSight Elite Tissue Oximetry Cable REF Hemfsm10 recall: Due to incorrect switching of Channel 1 and 2 on the module and flag labels
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
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Class II · 26 days ago
Philips North America Llc Ingenia Ambition S and Ingenia Ambition X recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Ventec Life Systems, Inc. HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 recall: Labeling; Oxygen Cylinders do not contain required medical gas labeling
Labeling; Oxygen Cylinders do not contain required medical gas labeling
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Class II · 26 days ago
Medline convenience kits containing Healthmark Instrument Channel recall: Kits contain Healthmark Instrument Channel Brushes
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of…
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Class II · 26 days ago
Philips North America Llc Name : 1. Intera 1.5T , 2. Intera 1.5T recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
AVID Medical, Inc. Halyard IV Start KIT Non-Sterile recall: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
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Class II · 26 days ago
Medline Convenience Kits: 1) Major Neuro VCH recall: The kits contain neurological sponges with the potential for unexpected
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may…
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Class I · 26 days ago
CooperSurgical, Inc. Inca Infant Nasal Cpap, Complete Set. Stay-Flex tubing recall: Potential to exhibit a loose connection between the flexible tubing
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss…
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Class II · 26 days ago
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head recall: The proximal thread depth of the spinal device is out of design specification
The proximal thread depth of the spinal device is out of design specification.
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Class II · 26 days ago
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall: Due to software issue with ultrasound system
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing…
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Class II · 26 days ago
Midmark IQvitals Zone, automatically and noninvasively measures recall: A performance issue may result in inaccurate blood pressure readings
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
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Class II · 26 days ago
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/ recall: Potential for detachment of ceramic tip due to manufacturing without
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
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Class II · 26 days ago
Philips North America Llc Ingenia 3.0T and Ingenia 3.0T CX recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Cardinal Health 200, LLC Presource Convenience Kits: 1) KIT, Usgpiv recall: The kits contain applicators that may exhibit an open or incomplete seal
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated…
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Class II · 26 days ago
Maquet SAS PowerLED 300 Concealed Lighting System Model Numbers: 1. ARD568474114A recall: The potential for the device to detach at the junction between the spring arm
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
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Class II · 26 days ago
Philips North America Llc Evolution upgrade 1.5T and Evolution upgrade 3.0T recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Ventec Life Systems, Inc. REF:HF2PC9 HomeFill Oxygen System recall: Labeling; Oxygen Cylinders do not contain required medical gas labeling
Labeling; Oxygen Cylinders do not contain required medical gas labeling
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Class II · 26 days ago
CooperVision, Inc. Brand Name: Pearle Vision 1 day Product Name: Contact Lens Model/ recall: A small number of lenses within the affected lot are of the incorrect power
A small number of lenses within the affected lot are of the incorrect power.