Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 8 months ago
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator recall: Complaints of the ceramic tip of the resection sheath breaking have
Complaints of the ceramic tip of the resection sheath breaking have been received.
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Class II · 8 months ago
Encore Medical, LP Brand Name: Reverse Shoulder Prosthesis Product Name: RSP Humeral recall: Knee and Humeral socket implants contain incorrect labeling
Knee and Humeral socket implants contain incorrect labeling.
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Class II · 8 months ago
Olympus Sheath, 10 Fr recall: Complaints of the ceramic tip of the resection sheath breaking have
Complaints of the ceramic tip of the resection sheath breaking have been received.
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Class II · 8 months ago
Convenience kits containing Tego Connectors Medline Dialysis Drsng Chng recall: Affected lots may exhibit issues with the silicone seal on Tego Connectors
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal…
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Class II · 8 months ago
Medline Kits containing Tego Connectors Medline Dialysis ON/OFF KIT SKU recall: Affected lots may exhibit issues with the silicone seal on Tego Connectors
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal…
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Class II · 8 months ago
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip recall: Firm is initiating a removal due to continued reports of adverse events
Firm is initiating a removal due to continued reports of adverse events.
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Class II · 8 months ago
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip recall: Firm is initiating a removal due to continued reports of adverse events
Firm is initiating a removal due to continued reports of adverse events.
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Class II · 8 months ago
Medline Convenience Kits: 1) SCC RF Pain Mgmt 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 · 8 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 · 8 months ago
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip recall: Firm is initiating a removal due to continued reports of adverse events
Firm is initiating a removal due to continued reports of adverse events.
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Class II · 8 months ago
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip recall: Firm is initiating a removal due to continued reports of adverse events
Firm is initiating a removal due to continued reports of adverse events.
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Class II · 8 months ago
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S recall: Firm is initiating a removal due to continued reports of adverse events
Firm is initiating a removal due to continued reports of adverse events.
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Class II · 8 months ago
Centinel Spine, Inc. Brand Name: Prodisc Product Name: Prodisc C SK Model/ recall: Products were mislabeled as the 6mm product but included the 5 mm product
Products were mislabeled as the 6mm product but included the 5 mm product.
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Class II · 8 months ago
Medline Convenience Kits: 1) Drawer 6-IV Fluids Gloves 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 · 8 months ago
Medline Convenience Kits: 1) Chest/Breast-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 · 8 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…
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Class II · 8 months ago
Medline Convenience Kits: 1) Spinal 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 · 8 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 · 8 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 · 8 months ago
Medline Convenience Kits: 1) OR Arteriogram 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 · 8 months ago
Medline Convenience Kits: 1) Open Heart 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 · 8 months ago
Medline Convenience Kits: 1) Basic Nerve Block Tray W/Linen 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 · 8 months ago
Intuitive Surgical, Inc. Da Vinci 5 Assy, DV5 Console, IS5000 Model/ recall: An error event following the release of a software version for the surgical
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external…
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Class II · 8 months ago
Medline Convenience Kits: 1) Arthroscopy 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…