CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
SmartRelease Onyx recalled by MicroAire Surgical Instruments
MicroAire Surgical Instruments is recalling SmartRelease Onyx, distributed nationwide in the US. The recall was initiated on 7 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1975-2025
- FDA event ID
- 96868
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2025
- FDA classified
- 12 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 7 May 2025 | Recall initiated by company | |
| 12 Jun 2025 | Classified by FDA | +36 days |
| 18 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Product as listed by the FDA
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);
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Questions about this recall
Is SmartRelease Onyx recalled?
Yes. MicroAire Surgical Instruments recalled SmartRelease Onyx on 7 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-1975-2025.
Why was it recalled?
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Which lots are affected?
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;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MicroAire Surgical Instruments
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartRelease Endoscopic Carpal Tunnel Release Handpiece recalled | MicroAire Surgical Instruments | Other | 26 states |
| Device | CLASS II | MicroAire SmartRelease Endoscopic System recalled | MicroAire Surgical Instruments | Sterility | Nationwide |
| Device | CLASS II | Sst Twist Drill, Standard Dia recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Sterility | VA |
| Device | CLASS II | MicroAire K-Wires recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Labeling Errors | VA |
| Device | CLASS II | Endotine Transbleph 5 (CFD-080-0167) recalled | MicroAire Surgical Instruments | Labeling Errors | VA |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |