Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error
Integra LifeSciences is recalling CUSA Clarity 36 kHz Sterilization Trays because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall involving a labeling error in the operator's manual regarding drying times. While the agency classification is Class II, the specific hazard is a documentation error that does not explicitly report hospitalizations or significant injuries, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Integra LifeSciences Corp. is recalling the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System, specifically the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A). The recall is due to a discrepancy in the CUSA Clarity Operators manual regarding the minimum dry time for the 36 kHz Sterilization Tray and components.
The manual currently states that 30 minutes is the minimum dry time for a 30-minute drying cycle. However, the system does not meet the Dry Time Criteria for this duration, as 40 minutes are required for complete drying. This recall is classified as Class II by the FDA.
The affected products were distributed in the United States and internationally, including in Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. Users should refer to the updated instructions or contact the manufacturer for guidance on the correct drying time to ensure proper sterilization.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
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)
- Brazilian OPS Manual P/N 60905208
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.
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