Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra Ojemann Cortical Stimulator Recalled by Integra Burlington MA, Inc. Due to If the headphone jack is in use during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra Burlington MA, Inc. directly.
Affected Products
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
Quantity: 371 units
Why Was This Recalled?
If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra Burlington MA, Inc.
Integra Burlington MA, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report