Stryker Puerto Rico, LLC – FDA 483, Feb 20, 2026

Stryker Puerto Rico, LLC, a medical device manufacturer in Arroyo, PR, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately validate a critical test method used to detect manufacturing defects in its StrykeFlow 2 product family, a product that previously experienced a recall. Additionally, the methods for monitoring quality management system processes were found to be inadequate, specifically regarding data collection, action triggers for deviations, and data verification.