Integra LifeSciences Recalls CUSA Clarity Ultrasonic Tissue Ablation Systems
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect regarding drying time, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall involves the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system, which does not meet the Dry Time Criteria for a 30-minute drying cycle.
The current CUSA Clarity Operators manual states that 30 minutes is the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components. However, the source text indicates that 40 minutes is required for complete drying. This discrepancy means the equipment may not dry properly within the time specified in the manual.
The affected units were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. The specific code information associated with the recall is the Chinese-Simplified OPS Manual P/N 60905778. Users of this equipment should contact the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 820
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Chinese-Simplified OPS Manual P/N 60905778
Distribution
Part of a larger recall action
This product is one of 42 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · inadequate drying
See all →- HighUretero-reno fiberscopes recalled due to inadequate channel drying
FDA (Devices) · 2023-11-29
- HighTransnasal Esophagovideoscope Recalled Due to Unvalidated Drying Process
FDA (Devices) · 2023-11-29
- HighSmall intestinal videoscope recalled due to inadequate channel drying process
FDA (Devices) · 2023-11-29
- ModerateIntegra CUSA Clarity System Recalled for Sterilization Tray Drying Defect
FDA (Devices) · 2019-12-18
- ModerateIntegra C7000 CUSA Clarity System Recalled for Inadequate Drying Time
FDA (Devices) · 2019-12-18