Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe… — Class II medical device recall Z-0058-2014
Terminated recall by Integra LifeSciences Corp., reported 2013-10-30, distributed nationwide. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain
| Recall number | Z-0058-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2013-06-11 |
| Classified | 2013-10-23 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 175 kits |
| Lot numbers | 130712, 172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942, 210912, 220612 |
| Model numbers | IM3.SR |
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Reason for recall
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
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-0058-2014. 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.