Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not 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: This is an FDA Class II recall involving a procedural discrepancy in drying times for a sterilization tray. No injuries or illnesses are reported, and the hazard is related to equipment performance rather than direct patient harm, fitting the criteria for a moderate severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall involves the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) and the associated Dutch OPS Manual (P/N 60905211).
The recall is being issued because the 36 kHz Sterilization Tray system does not meet the Dry Time Criteria for a 30-minute drying cycle. While the current CUSA Clarity Operators manual states 30 minutes as the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components, 40 minutes is actually required for complete drying.
The affected products were distributed in the United States and internationally. Users of this equipment should contact the manufacturer for further instructions regarding the recall.
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)
- Dutch OPS Manual P/N 60905211
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 · improper sterilization
See all →- HighKarl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05