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 Convenience Kits: 1) Drape Pack-Choice 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) BAP North Robotic Surgery CDS 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) Lvad Driveline 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 Surgical Packs: 1) Pack,Universal,Ultragard,5/CS 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) CVC 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 I · 6 months ago
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO recall: Convenience kit contains a syringe in which the rotating adapter may unwind
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection…
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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
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
Medline Convenience Kits: 1) Drape 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
DFI Co., Ltd. One Step UTI in vitro diagnostic test REF: 3374 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 Sammc Angiography kit. Model Numbers: Samm066-15 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
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
Medline Convenience Kits: 1) Burn 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
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
Medline Convenience Kits: 1) Ancillary Pack-Lf 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
Katalyst Surgical, LLC DEX recall: Ophthalmic Tissue Forceps (DEX") are sterile
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or…
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Class I · 6 months ago
AVID Medical, Inc. Halyard Heart Cath, Self Regional 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 I · 6 months ago
AVID Medical, Inc. Halyard Neuro IR Peripheral 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
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
Medline Convenience Kits: 1) OB 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 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…