MicroAire® 81025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847399017253), received between Aug 3, 2026 and Aug 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K080560, K223406); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50108381 ↗
• MalfunctionAug 3, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50108379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080560, K223406. One submission often covers many models, so check the product and lot details in each record.

• Z-1975-2025 · May 7, 2025 · Open, Classified
  Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly;