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Lower risk Medical device recall · FDA · Published October 21, 2019

Integra C7000 Clarity Ultrasonic System: 30-min drying cycle risk

Integra recalls C7000 Clarity Ultrasonic Tissue Ablation System due to 30-minute drying cycle not meeting required 40-minute dry time for sterilization trays, risking incomplete sterilization.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0637-2020Medical deviceIntegra LifeSciences ›
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Contact the company

Recalling firmIntegra LifeSciences Corp.311 Enterprise Dr · Plainsboro, NJ 08536-3344
✎ GovInfoNow plain-language explainer

Integra is recalling the C7000 Clarity Ultrasonic Tissue Ablation System because the sterilization tray doesn't dry long enough for proper sterilization. This could lead to incomplete sterilization and potential infection risks if the device is used without proper drying. Read more at govinfonow.com/recall/66626-integra-c7000-clarity-ultrasonic-system-30-min-drying-cycle-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66626-integra-c7000-clarity-ultrasonic-system-30-min-drying-cycle-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0637-2020

Cite this page

“Integra C7000 Clarity Ultrasonic System: 30-min drying cycle risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66626-integra-c7000-clarity-ultrasonic-system-30-min-drying-cycle-risk. Based on FDA recall #Z-0637-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2020%22&limit=1).

Integra LifeSciences Corp. recalled the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System on Oct. 21, 2019, according to the FDA. The device fails to meet dry time criteria for sterilization trays. This Class II recall was voluntary and initiated by the firm.

How to tell if you have it

  • Brand: Integra LifeSciences
  • Product: C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
  • Component: 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A)
  • Quantity: 820 units
  • Distribution: US states AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, UT, VA, WA, WI, WV and international locations SG, MX, CA, JP, AU, CO, TH, HK

The hazard

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes is the minimum Dry Time, but 40 minutes is required for complete drying.

Context

GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Recent brand recalls include the AURORA Surgiscope System Recall on Feb. 6, 2025, and the MediHoney Wound Dressing Gel Recall on Jan. 10, 2025. Other recent recalls of similar products include the Integra LifeSciences OmniTract Surgical Retractor System Recall (June 5, 2026), BD 60-In Extension Sets recall (June 16, 2026), and Medline Convenience Kits recall (Jan. 7, 2026).

How to tell if you have this one

Check for the C7136 Rev C or 72904491 Rev A sterilization tray model numbers on the C7000 Clarity system. The device was sold in Brazil with the Brazilian OPS manual.

  • Brand
    Integra LifeSciences
  • Category
    Medical device
FDA recall event · 42 products

All 42 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV International: SG MX CA JP AU CO TH HK
Recall numberProduct, codes & lotsQuantity
Z-0613-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; US Ops Manual P/N 60905769820
Z-0614-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; US Ops Manual P/N 60905197820
Z-0615-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; OUS Ops Manual P/N 60905789820
Z-0616-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; OUS Ops Manual P/N 60905217820
Z-0617-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; French OPS Manual P/N 60905770820
Z-0618-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; French OPS Manual P/N 60905198820
Z-0619-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Spanish OPS Manual P/N 60905771820
Z-0620-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Spanish OPS Manual P/N 60905199820
Z-0621-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; German OPS Manual P/N 60905772820
Z-0622-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; German OPS Manual P/N 60905200820
Z-0623-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Italian OPS Manual P/N 60905773820
Z-0624-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Italian OPS Manual P/N 60905201820
Z-0625-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Swedish OPS Manual P/N 60905774820
Z-0626-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Swedish OPS Manual P/N 60905202820
Z-0627-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Russian OPS Manual P/N 60905775820
Z-0628-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Russian OPS Manual P/N 60905203820
Z-0629-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Japanese OPS Manual P/N 60905776820
Z-0630-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Japanese OPS Manual P/N 60905204820
Z-0631-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Chinese-Traditional OPS Manual P/N 60905777820
Z-0632-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Chinese-Traditional OPS Manual P/N 60905205820
Z-0633-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Chinese-Simplified OPS Manual P/N 60905778820
Z-0634-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Chinese-Simplified OPS Manual P/N 60905206820
Z-0635-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Portuguese OPS Manual P/N 60905779820
Z-0636-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Portuguese OPS Manual P/N 60905207820
Z-0637-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Brazilian OPS Manual P/N 60905780820
Z-0638-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Brazilian OPS Manual P/N 60905208N/A
Z-0639-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Danish OPS Manual P/N 60905781N/A
Z-0640-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Danish OPS Manual P/N 60905209N/A
Z-0641-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Finnish OPS Manual P/N 60905782N/A
Z-0642-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Finnish OPS Manual P/N 60905210N/A
Z-0643-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Dutch OPS Manual P/N 60905783N/A
Z-0644-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Dutch OPS Manual P/N 60905211N/A
Z-0645-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Korean OPS Manual P/N 60905784N/A
Z-0646-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Korean OPS Manual P/N 60905212N/A
Z-0647-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Polish OPS Manual P/N 60905785N/A
Z-0648-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Polish OPS Manual P/N 60905213N/A
Z-0649-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Croatian OPS Manual P/N 60905786N/A
Z-0650-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Croatian OPS Manual P/N 60905214N/A
Z-0651-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Czech OPS Manual P/N 60905787N/A
Z-0652-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Czech OPS Manual P/N 60905215N/A
Z-0653-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Norwegian OPS Manual P/N 60905788N/A
Z-0654-2020C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Norwegian OPS Manual P/N 60905216N/A
Based on the official FDA remedy

What to do — step by step

  1. Verify Drying Time

    Check the sterilization tray model number to confirm it's C7136 Rev C or 72904491 Rev A.

Where it went and when

Where it was distributed

Distributed in 36 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV International: SG MX CA JP AU CO TH HK” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

1. Firm started the recall: Oct 21, 201912. FDA classified it Class II: Dec 8, 201923. Published in FDA’s Enforcement Report: Dec 18, 201934. FDA terminated the recall: May 7, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0637-2020 (October 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0637-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA