Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 10, 2013
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
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,…
Integra Burlington Ma, Inc. recalled Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intra… - a moderate-severity action.
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intra… was recalled by Integra Burlington Ma, Inc. in April 10, 2013. Reason: If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as…. Check the official notice for the remedy. Verify recall #Z-1030-2013 with the FDA Devices before acting.
The recall
Integra Burlington Ma, Inc. issued this moderate-severity FDA Devices recall-If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as….
- Moderate
- severity level
- 371 units
- affected scope
- Class II
- classification
- April 10, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1030-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1030-2013) was formally reported on April 10, 2013, with the manufacturer initiating the action on March 18, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Integra Burlington Ma, Inc. is listed as the recalling firm, operating out of Burlington, MA. Federal records list the affected scope as 371 units.
The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
371 units
Related Recalls
6
3 from same agency
Product description
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1030-2013 |
| Date reported | April 10, 2013 |
| Date initiated | March 18, 2013 |
| Recalling firm | Integra Burlington Ma, Inc. |
| Firm location | Burlington, MA |
| Affected scope | 371 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Swe… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1030-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.. Recalled by Integra Burlington Ma, Inc.. Units affected: 371 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2013. Severity: Moderate. Recall number: Z-1030-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1030-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 10, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.