Latest recalls — page 131
Older notices, newest first.
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Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Straight Art, 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
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall: The catheter inflation tag attached to the device may contain an incorrect
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures…
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Class II · 6 months ago
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall: The catheter inflation tag attached to the device may contain an incorrect
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures…
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Class II · 6 months ago
Uvlizer c/o RAIS INTERNATIONAL LLC The product is a handheld ultraviolet-C germicidal recall: In some foreseeable use conditions, the products can expose nearby persons
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by…
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Class II · 6 months ago
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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Class II · 6 months ago
LSL Healthcare, Infant Central Line Dressing Change 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
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) SYR Control 8ML Rotating 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, 25cm 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
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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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
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall: The catheter inflation tag attached to the device may contain an incorrect
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures…
-
Class II · 6 months ago
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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Class II · 6 months ago
Medline Kits: 1) GYN Laparoscopy 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
Medline Syringes: 1) Syringe 12ML Control W/Rotator 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) Newborn Admission 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 Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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Class II · 6 months ago
Medline Kits: 1) Bwnboro Craniotomy 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
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm 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 Kits: 1) Arthroscopy 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
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF 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
Angiodynamics, Inc. Soft-Vu 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)…