Integra Ojemann Cortical Stimulator — Class II medical device recall Z-1030-2013
Terminated recall by Integra Burlington MA, Inc., reported 2013-04-10, distributed nationwide. If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as
| Recall number | Z-1030-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra Burlington MA, Inc., Burlington, MA, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-04-01 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2014-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CZ, DK, ES, GB, HU, IE, IT, MA, NL, PL, PT, SE, TR, ZA |
| Quantity | 371 units |
| Model numbers | OCS2 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1030-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.