MicroAire SmartRelease Endoscopic System — Class II medical device recall Z-2107-2018
Terminated recall by MicroAire Surgical Instruments, LLC, reported 2018-06-13, distributed nationwide. The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
| Recall number | Z-2107-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroAire Surgical Instruments, LLC, Charlottesville, VA, United States |
| Recall initiated | 2018-04-19 |
| Classified | 2018-06-07 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CL, CZ, DE, DK, ES, FR, GB, HK, IE, IL, IN, IR, IT, JO, KR, LB, MX, NI, PL, RS, RU, SA, SE, SG, TH, TN, TR, TW |
| Quantity | 2,009 |
Product
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
Reason for recall
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
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-2107-2018. 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.