Reported Jul 15, 2026 · Ongoing · Updated Sep 16, 2026
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Integra LifeSciences Corp. (NeuroSciences)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. (NeuroSciences) · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
- Lot codes and dates
633 of 633 products
Products covered by this recall Model / number Barcodes Product as published 303210381780268468UDI 10381780268468 305510381780268505UDI 10381780268505 306910381780268512UDI 10381780268512 307610381780268529UDI 10381780268529 308610381780268536UDI 10381780268536 309210381780268550UDI 10381780268550 309310381780268567UDI 10381780268567 309610381780268581UDI 10381780268581 309810381780268598UDI 10381780268598 309910381780268604UDI 10381780268604 313310381780268680UDI 10381780268680 313710381780268697UDI 10381780268697 314210381780268710UDI 10381780268710 314610381780268734UDI 10381780268734 314810381780268758UDI 10381780268758 317610381780268826UDI 10381780268826 317710381780268833UDI 10381780268833 318510381780268857UDI 10381780268857 320110381780268871UDI 10381780268871 320310381780268888UDI 10381780268888 - Amount recalled
- 633 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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