Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 6 months ago
Medline Kits: 1) MTS Left Heart Kit-Carolinas HOS recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Medline Kits: 1) Hysteroscopy Pack recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Pigtail, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
Magellan Diagnostics, Inc. LeadCare¿ Plus Blood Lead Test Kit recall: Customers reported observing unexpectedly elevated results when using certain
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for…
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Class II · 6 months ago
Angiodynamics, Inc. AccuVu Angiographic Catheter, Omni Flush, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
Arrow International, LLC MAC" Two-Lumen Central Venous Access Kit for use with 7.5 recall: Due to receiving a notice from a supplier that the liquid adhesive
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
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Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
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Class II · 6 months ago
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm recall: Potential for detachment of a distal tip component of the device during use
Potential for detachment of a distal tip component of the device during use.
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Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
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Class II · 6 months ago
LSL Healthcare, Foley Urine Collection Kit, Model/ recall: Medical procedure kits were distributed containing Webcol Large Alcohol Prep
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
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Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Berenstein, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
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Class II · 6 months ago
Medline Kits: 1) Angiography Pack-Lf recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Medline Kits: 1) CATH LAB CDS recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
LSL Healthcare Wound Closure Tray, Model/ recall: Medical procedure kits were distributed containing Webcol Large Alcohol Prep
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
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Class II · 6 months ago
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: XXX
XXX
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Class II · 6 months ago
Angiodynamics, Inc. AccuVu Angiographic Catheter, Straight Flush, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
Medline Namic Guidewires: 1) Guidewire 3MMJ 0.035X260CM LT recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm recall: Potential for detachment of a distal tip component of the device during use
Potential for detachment of a distal tip component of the device during use.
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Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
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Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
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Class II · 6 months ago
Medline Kits: 1) Heart Transplant Biopsy recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…