Latest recalls — page 134
Older notices, newest first.
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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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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)…
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Class II · 6 months ago
Hetero Labs Limited Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recall: Discoloration: Firm received five (5) complaints stating
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
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Class II · 6 months ago
B Braun Medical Inc Sterile Water for Injection USP, 3000 mL bags recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Class II · 6 months ago
B Braun Medical Inc 0.9 % Sodium Chloride Irrigation, USP, 3000 mL bags recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Claravis , 10 mg, Packaged as a) 100-count carton recall: Failed Impurities/Degradation Specifications: Out of specification
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
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Class II · 6 months ago
B Braun Medical Inc Lactated Ringer's Irrigation, 3000 mL bags, Sterile, Ex only recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Class III · 6 months ago
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles recall: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…
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Class II · 6 months ago
Leading Pharma, LLC Furosemide Tablets, USP, 80 mg, 100 Tablets bottles recall: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.