In regulatory terms, what is a potential outcome of non-compliance with safety standards?

Non-compliance with safety standards can lead to serious consequences for manufacturers, and one significant outcome is the issuance of product recalls. When a device is found to violate safety standards, whether due to defects or risks posed to patients and users, regulatory authorities may mandate a recall to protect public health and safety. This action reflects the firm's inability to meet the required safety measures, which can result in adverse effects or hazards associated with the use of the product.

Product recalls serve as a critical measure to mitigate risk, ensure consumer safety, and uphold regulatory standards. They also initiate a response process that includes notifying consumers, healthcare providers, and potentially involved authorities, illustrating the serious nature of compliance requirements in the medical device industry.

The other options suggest positive outcomes, which do not align with the consequences of non-compliance. Increased market share, recognition for innovation, or partnerships with global manufacturers are generally associated with successful compliance and effective product management, rather than the fallout experienced from failing to adhere to safety standards.