When a Recall or FSCA is Required
A recall or Field Safety Corrective Action (FSCA) is required when:
- A device on the market poses an unacceptable risk to patients or users
- A manufacturing or design defect has been identified
- Labelling is misleading or incorrect in a safety-critical way
- MFDS orders a recall following adverse event review or inspection findings
Types of corrective action
| Action | Description |
|---|---|
| Recall (회수) | Physical retrieval of products from the supply chain and/or patients |
| FSCA / Field Safety Notice | Corrective action in the field — may not require physical retrieval (e.g., updated IFU, safety advisory) |
MFDS recall classification
| Class | Risk |
|---|---|
| Class 1 | Reasonable probability of serious adverse health consequences or death |
| Class 2 | May cause adverse health consequences but not Class 1 severity |
| Class 3 | Unlikely to cause adverse health consequences |