SmartRelease Endoscopic Carpal Tunnel Release Handpiece — Class II medical device recall Z-2222-2019
Terminated recall by MicroAire Surgical Instruments, LLC, reported 2019-08-14, distributed in CA, CT, FL, GA, IA, IL, IN, MD…. There was a higher than normal incidence rate of the blade not retracting when tightening.
| Recall number | Z-2222-2019 |
|---|---|
| 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 | 2019-06-26 |
| Classified | 2019-08-08 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-04-29 |
| Distributed | CA, CT, FL, GA, IA, IL, IN, MD, MI, MN, MS, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY |
| Countries outside the US | AU, CZ, DE, FR, TW |
| Quantity | 103 |
| Serial numbers | 1004, 1031, 13388, 13389, 13390, 13391, 13392, 13393, 13394, 13395, 13396, 13397, 13398, 13399, 13400, 13401, 13402, 13403, 13404, 13405, 13406, 13407, 13408, 13409, 13410 and 78 more |
| Model numbers | 81014, 83014 |
Product
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Reason for recall
There was a higher than normal incidence rate of the blade not retracting when tightening.
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-2222-2019. 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.