Brand Name: SmartRelease ESTR (Endoscopic soft tissue… recallZ-1975-2025 · MicroAire Surgical Instruments, LLC · initiated May 7, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MicroAire Surgical Instruments, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
FDA root cause category: Under Investigation by firm
What the company is doing
On May 7, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Specifically, we re asking that you please complete and send back page two of this letter to [email protected] or via fax at 800-648-4309, and to send back your unused product, per the directions. MicroAire will replace these unused units free of charge. If you have any questions about this Recall, please contact MicroAire Customer Service at 1-800-722-0822 between the hours of 8:30 AM and 5:00 PM (EST) Monday through Friday. We apologize for this inconvenience and are taking the proper steps to ensure that this will not happen in the future.
Recall details
- Recall number
- Z-1975-2025
- Status
- Open, Classified
- Initiated by the company
- May 7, 2025
- Posted by the FDA
- Jun 12, 2025
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Quantity
- 1,451 eaches
- Product code
- EMF
- FDA submissions
- K223406
- Distribution
- Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Product description
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
Code information (models, lots, serial numbers)
Catalog (SKU) Numbers:(1) 83030-1 (single pack), (2) 83030-6 (six pack) and (3) 83030-6-CE (six pack OUS only); UDI-DI: (1) 00847399017246 (single pack), (2&3) 00847399015860 (six pack); Lot Numbers: (1) 104842032025, (2) 104841032025, 104873032025, 104885042025, 104902042025, (3) 104865032025;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- MicroAire® 83030-6Microaire Surgical Instruments LLC · Knife, Surgical1 recall0 reports
- MicroAire® 83030-1Microaire Surgical Instruments LLC · Knife, Surgical1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K223406 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MicroAire® 81025Microaire Surgical Instruments LLC · Arthroscope2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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