Device Recall, Corrections and Removals

A medical device recall is initiated when a product poses a health risk or violates Regulatory requirements. A correction addresses the issue without removing devices from the market, while a removal involves complete withdrawal due to serious safety, performance, or quality concerns that may impact patient health or device effectiveness.

Recall management includes conducting a Health Hazard Evaluation (HHE), preparing Field Safety Notices (FSN) and Field Safety Corrective Actions (FSCA), managing vigilance reporting, coordinating customer communication, tracking returned products, and maintaining audit-ready documentation to demonstrate full Regulatory compliance throughout the recall lifecycle.

Manufacturers must submit correction and removal reports to Regulatory authorities within region-specific timelines. This includes documenting risk evaluations, implementing corrective actions, maintaining traceable communication, and ensuring translation accuracy. The goal is to ensure consistency, transparency, and compliance across all markets during global recall activities.

A Health Hazard Evaluation (HHE) assesses the severity, likelihood, and impact of a medical device issue on patient safety. It determines whether a recall, correction, or removal is required and provides the evidence base for Regulatory submissions and communication with health authorities during post-market safety actions.

During a recall, manufacturers must notify healthcare providers, distributors, and users using clear, concise communication such as Field Safety Notices (FSN). Notifications must include product details, risks, corrective steps, and contact information, ensuring acknowledgment tracking to demonstrate Regulatory compliance and proper communication documentation.

Digital recall management systems and dashboards enable monitoring of affected device batches, returned units, and corrective action progress. They support traceability, ensure documentation consistency, and provide transparency in communication with Regulatory authorities, facilitating faster response and closure of recall activities.

Under U.S. law, 21 CFR Part 806 governs reporting of corrections and removals that mitigate health risks, while 21 CFR Parts 7 and 810 address recall classifications and processes. Manufacturers must promptly notify the Food and Drug Administration (FDA) when device corrections or removals are health-related.

A good faith effort is demonstrated by documenting prompt outreach to consignees, tracking acknowledgments, following up with non-responders, and maintaining detailed communication records. This ensures transparency, accountability, and proof that the manufacturer acted proactively to protect users and comply with recall requirements.

A voluntary recall is initiated by a manufacturer upon identifying a device defect or potential hazard. A mandatory recall is ordered by a Regulatory authority, such as the FDA, when corrective action is not taken voluntarily. Both require prompt risk assessment, notification, and product withdrawal or correction.

In global recalls, multilingual translation ensures that Field Safety Notices (FSN), customer letters, and Regulatory reports are accurately communicated in each country’s official language. Clear translation supports user understanding, reduces miscommunication risks, and ensures compliance with local Regulatory and linguistic requirements for recall notifications.