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
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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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)…
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Class II · 6 months ago
LSL Healthcare, IV Start 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. AccuVu 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
Davol, Inc. Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm recall: Potential for product to contain foreign matter
Potential for product to contain foreign matter, confirmed to be inspect fragments.
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Class II · 6 months ago
SurgiSmoke Solutions Flamingo Funnel Medium recall: Certain lots of product were associated with a manufacturing nonconformance
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
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Class II · 6 months ago
LSL Healthcare, Central Line Dressing 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
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) General Laparoscopy 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) SYR Cntrl 10ML Ring W/ROT NB 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, Standard 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
Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS recall: The product correction was initiated because B Braun is issuing a voluntary
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as…
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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 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) Labor Pack-22025208-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
Magellan Diagnostics, Inc. LeadCare Ultra 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
Integra LifeSciences Corp. CUSA Clarity C7000 Console recall: Software issue that renders the touch screen unresponsive
Software issue that renders the touch screen unresponsive.
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Class II · 6 months ago
Arrow International, LLC Percutaneous Sheath Introducer with 7.5 - 8 Fr. Catheter 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, Cobra , 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)…