Integra Ojemann Cortical Stimulator Recalled for Potential Electrical Injury Risk
Integra Burlington MA, Inc. is recalling 371 Ojemann Cortical Stimulators because a non-intended voltage could be transmitted to patients during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential risk of injury to patients, but the source text does not report any actual injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Integra Burlington MA, Inc. is recalling 371 units of the Integra Ojemann Cortical Stimulator (Catalogue No. OCS2). The device is intended for intraoperative cortical stimulation mapping procedures. The affected units have serial numbers ranging from 1010 through 1380.
The recall is due to a potential safety hazard where a non-intended voltage, such as static electricity, could be transmitted to the patient if the headphone jack is in use during a surgical procedure and comes in contact with the outer case of the unit. This transmission could be a potential source of injury.
The affected devices were distributed worldwide, including nationwide in the United States and in Austria, Belgium, Czech Republic, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa. Users should contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
- Manufacturer
- Integra Burlington MA, Inc.
- Hazard
- Affected units
- 371
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number Range: 1010 through 1380
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · electrical injury
See all →- SevereAlpha Omega Engineering Recalls Neuro Omega Systems Due to Tissue Harm Risk
FDA (Devices) · 2019-05-15
Other medical device recalls
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Similar recalls
- HighCascade IOMAX Cortical Module recalled for defective circuit board
FDA (Devices) · 2024-07-24
- HighCascade IOMAX Cortical Module recalled for potential electrical shock hazard
FDA (Devices) · 2024-05-29
- HighStryker C2 Nerve Monitor Recalled for Potential Nerve Injury Risk
FDA (Devices) · 2019-10-09
- SevereImpella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- HighMedtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Loss of Stimulation
FDA (Devices) · 2013-11-20
- HighIntellis AdaptiveStim Spinal Cord Stimulator unable to reprogram
FDA (Devices) · 2024-05-08