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Class II

MedTech Current publications and recall entries tagged Class II.

Device RecallsRecall Watch

FDA Class II Recall Watch: 16–22 August 2026

Eight selected FDA Class II recall events for 16–22 August 2026 highlight neonatal breathing-circuit failures, erroneous diagnostic results, software-driven measurement and analyzer risks, an implant machining defect, endotoxin-related surgical-kit actions, a CT bolus-tracking issue, and high-volume urostomy pouch leakage. The issue emphasizes clinical follow-up, inventory control, result review, software correction, and component-level quality management.

Device RecallsRecall Watch

FDA Class II Recall Watch: 9–15 August 2026

Eight selected FDA Class II recall events for 9–15 August 2026 highlight diagnostic false negatives, interventional imaging software failures, a potential sterilization underdose, endotoxin-related kit actions, reagent rework, cryosurgical pressure risk, and an incorrect guidewire. The issue centers on clinically meaningful failures plus substantial inventory, notification, correction, and replacement work.