OmniTract Surgical Retractor System
Integra LifeSciences is recalling the OmniTract Surgical Retractor System due to insufficient drying time instructions in the user manual.
Review the updated instructions for use provided by the manufacturer and ensure that the sterilization drying time is extended to 90, 110, or 120 minutes as required by your specific sterilization cycle.
Recall at a glance
- Quantity recalled
- 633 units
Why it was recalled
Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the current instructions for use specify an insufficient drying time after sterilization. The required drying time must be extended to 90, 110, or 120 minutes, depending on the specific sterilization cycle used, to ensure proper processing.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
- UDI-DI
- 10381780268468, 10381780268505, 10381780268512, 10381780268529, 10381780268536, 10381780268550, 10381780268567, 10381780268581, 10381780268598, 10381780268604, 10381780268680, 10381780268697, 10381780268710, 10381780268734, 10381780268758, 10381780268826, 10381780268833, 10381780268857, 10381780268871, 10381780268888
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Other recent recalls from Integra LifeSciences Corp. (NeuroSciences)
Editorial summary by Recall Canary · summary updated 2026-07-10 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification