Surgical Theater Inc recalls Surgical Planner
- Recalling company
- Surgical Theater Inc
- Product
- Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
- Reason
- A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 16, 2025
- Reported
- Nov 5, 2025
- Distribution
- Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.
- Status
- Terminated
- Quantity
- 3 units
- Lot / codes
- UDI/DI 00860003884119
- Company location
- Beachwood, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0325-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0325-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.