Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceEncore Medical, LpClass IIEMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
- 2019-12-18FDA-DeviceSmiths Medical ASD Inc.Class IMedfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.
- 2019-12-18FDA-DeviceCook Inc.Class ICrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
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