MDT · News · 20261021N

Product Recall and Safety

Medtronic plc · 2026-10-21 · Importance 38 · Surprise 60

The U.S. Food and Drug Administration issued a Class II recall for 3,746 Medtronic biopsy kits. The recall concerns material deviations affecting optical tracking and involves the company’s medical-surgical portfolio. The reported unit count is below the stated financial materiality thresholds, but the FDA action represents a company-specific regulatory and product-safety event.

Key facts

• The FDA issued a Class II recall for 3,746 Medtronic biopsy kits due to material deviations affecting optical tracking. source