Integra LifeSciences OmniTract Surgical Retractor System Recall: Dry Time Not Extended
Integra LifeSciences recalls 633 OmniTract Surgical Retractor System models due to dry time not being extended to 90-120 minutes as required for sterilization cycles.
Lower-risk recall
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Contact the company
What happened, in plain English
Integra LifeSciences is recalling 633 models of their OmniTract Surgical Retractor System because the dry time after sterilization isn't extended to 90-120 minutes as specified. This could affect proper sterilization procedures. Read more at govinfonow.com/recall/49041-integra-lifesciences-omnitract-surgical-retractor-system-recall-dry-time-not.
Source Summary by GovInfoNow · govinfonow.com/recall/49041-integra-lifesciences-omnitract-surgical-retractor-system-recall-dry-time-not · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2714-2026
Cite this page
“Integra LifeSciences OmniTract Surgical Retractor System Recall: Dry Time Not Extended.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49041-integra-lifesciences-omnitract-surgical-retractor-system-recall-dry-time-not. Based on FDA recall #Z-2714-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2714-2026%22&limit=1).
Why it’s dangerous
The dry time after sterilization isn't extended to 90-120 minutes as required, which could lead to improper sterilization procedures.
Who’s affected
Surgical equipment users and healthcare facilities that use the OmniTract Surgical Retractor System
How to tell if you have this one
Product codes listed in the recall notice (633 models)
- Brand
Integra LifeSciences- Category
Medical device
What to do — step by step
Check if your OmniTract Surgical Retractor System is one of the 633 models listed in the recall
The recall includes specific product codes with UDI numbers
Contact Integra LifeSciences for guidance on next steps
They provide instructions for handling the recalled products
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-2714-2026 (June 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2714-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.