FDA recall class
FDA classifies device recalls into three classes by severity:
- Class I — dangerous; may cause death or serious injury.
- Class II — temporary or medically reversible adverse event possible.
- Class III — unlikely to cause adverse health consequences (often labeling / paperwork issues).
Why it matters to buyers: Serial-range-specific — a Class II recall may or may not affect a given unit. Check by serial number before purchase. Sellers should disclose; verify independently at the FDA Recalls database.
Why it matters to engineers: FDA Recalls database is authoritative. Recall actions can include software patch, parts replacement, modification, or removal from service.