MicroAire Surgical Instruments, LLC
Complete recall history across all FDA and CPSC categories — 14 total recalls
MicroAire Surgical Instruments, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (14)
FDA medical device enforcement actions by MicroAire Surgical Instruments, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| May 7, 2025 | Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Ony... | Potential that the blade can unintentionally cut tissue prior to the user dep... | Class II |
| Jun 26, 2019 | SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), par... | There was a higher than normal incidence rate of the blade not retracting whe... | Class II |
| Apr 19, 2018 | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, S... | The Instructions for Use (IFU) is incorrect with regards to sterilization par... | Class II |
| May 22, 2017 | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This ... | One lot was found to contain both the correct twist drill (1.6mm) as well as ... | Class II |
| Feb 21, 2017 | MicroAire K-Wires | Mislabeling on three lots of K-Wires. The incorrect product description " dua... | Class II |
| May 6, 2016 | Endotine Transbleph 3.5 (CFD-080-0167) | MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph... | Class II |
| Mar 11, 2016 | Pneumatic Impactor, General Surgery, With Microaire Hose Connector Profes... | MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumat... | Class II |
| Feb 8, 2016 | MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device | MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecc... | Class II |
| Feb 8, 2016 | MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula | Complaints that the cannula bent/broke during surgery. | Class II |
| Jun 12, 2015 | ASP-1020 LipoTower with Aspiration Pump. Medical use. | There is potential risk of electrical shock if lead wires inside the device b... | Class II |
| Jun 12, 2015 | ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. | There is potential risk of electrical shock if lead wires inside the device b... | Class II |
| Aug 12, 2013 | Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed i... | A medical device used in surgical procedures was packaged in a pouch in which... | Class II |
| Aug 12, 2013 | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a steril... | A medical device used in surgical procedures was packaged in a pouch in which... | Class II |
| Apr 26, 2012 | Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich D... | Medical device was not manufactured under Good Manufacturing Procedures and a... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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