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.
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.
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.
The dry time after sterilization isn't extended to 90-120 minutes as required, which could lead to improper sterilization procedures.
Surgical equipment users and healthcare facilities that use the OmniTract Surgical Retractor System
Product codes listed in the recall notice (633 models)
The recall includes specific product codes with UDI numbers
They provide instructions for handling the recalled products
The dry time after sterilization isn't extended to 90-120 minutes as required for sterilization cycles.
633 models of the OmniTract Surgical Retractor System
Check if your product is listed in the recall, then contact Integra LifeSciences for guidance.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2714-2026 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-2714-2026 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
