Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class I · 6 months ago
AVID Medical, Inc. Halyard CATH LAB kit recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
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Class II · 6 months ago
Medline Convenience Kits: 1) Central Line Universal Inserti recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
DFI Co., Ltd. One Step 10A in vitro diagnostic test recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Medline Convenience Kits: 1) Picc Catheter Insertion Tray recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) KIT Urology Sling recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Intuitive Surgical, Inc. Brand Name: Da Vinci X and Da Vinci Xi Product Name: da recall: Due to manipulator containing screws with in the arm sub-assembly that my
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
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Class II · 6 months ago
Medline Convenience Kits: 1) C-Section Pack recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Orthorebirth Co Ltd BioCera Fibers, Bioresorbable Bone Void Filler recall: Resorbable bone void filler falls outside standard specifications
Resorbable bone void filler falls outside standard specifications.
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Class II · 6 months ago
Medline Convenience Kits: 1) ADMIT KIT recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
DFI Co., Ltd. One Step pH in vitro diagnostic test REF: 31I4P recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Medline Convenience Kits: 1) Neuro Shunt- Codman recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) KIT Ophthalmic Rupture Globe recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
DFI Co., Ltd. One Step P in vitro diagnostic test REF: 8194 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class I · 6 months ago
AVID Medical, Inc. Halyard Cardiac Cath Pack kit recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
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Class II · 6 months ago
DFI Co., Ltd. Qucare Total Cholesterol in vitro diagnostic test REF: 6407 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
Orthorebirth Co Ltd Zenbone, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z recall: Resorbable bone void filler falls outside standard specifications
Resorbable bone void filler falls outside standard specifications.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class I · 6 months ago
AVID Medical, Inc. Halyard CATH LAB kit recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
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Class II · 6 months ago
Erbeflo CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & recall: Devices providing sterile water/CO2/air to endoscopes were manufactured
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Drawer 6-IV recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Boston Scientific Corporation Lux-Dx II Plus, Arrythmia detector and alarm, Model M312 recall: For some patients upgraded from a LUX-Dx M301 device to a new Model M302
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both…
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Class I · 6 months ago
AVID Medical, Inc. Halyard VA Detroit Cath LAB Pack kit. Model Numbers: Vmcd029 recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
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Class II · 6 months ago
Medline Surgical Drapes: 1) Sheet,Drape,40X58,Sterile recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…