Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time.
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: The recall is classified as FDA Class II. The hazard involves a failure to meet drying time criteria, which is a procedural defect rather than a direct, immediate physical injury risk like a structural failure or contamination. No injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall is due to a defect in 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 be fully dried within the timeframe 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. Users of this equipment should contact Integra LifeSciences Corp. for further instructions on how to address the drying time discrepancy.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
- 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)
- Brazilian OPS Manual P/N 60905780
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
Similar recalls
- ModerateCUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness
FDA (Devices) · 2026-04-29
- ModerateOmniTract Surgical Retractor System sterilization instructions require extended dry time
FDA (Devices) · 2026-07-15
- HighIntegra CUSA Clarity Footswitch Recalled for Unintended Activation
FDA (Devices) · 2018-03-07
- HighFDA Recalls CUSA Excel Surgical Handpiece for Housing Cracks
FDA (Devices) · 2024-07-03
- ModerateMedical device recall: sterilization validator with incorrect incubation time
FDA (Devices) · 2025-03-05
- HighCarefusion Thora-Para Catheter Drainage Tray Recalled for Internal Valve Leaks
FDA (Devices) · 2020-07-29