What medical-device recall classifications mean

The classification describes the recall action

FDA assigns Class I, II, or III to a medical-device recall after assessing the health hazard associated with the recalled product. The label describes the relative degree of risk in that recall action; it is not a rating of every product made by that manufacturer.

MedWatcher preserves the classification supplied by the source record. We do not assign, raise, lower, or infer a classification ourselves.

FDA Class I, II, and III

FDA describes Class I as a situation with a reasonable probability of serious adverse health consequences or death. Class II covers temporary or medically reversible harm, or a remote probability of serious harm. Class III means adverse health consequences are not likely.

Those definitions concern the affected recall situation. They do not tell you whether your individual unit is included, whether a notice has changed, or what is appropriate for you personally.

Health Canada uses Type I, II, and III

Health Canada uses Type I, II, and III health-hazard classifications for medical-device recalls. Its guide defines Type I as the highest-concern category and provides separate definitions for each type.

Keep the source jurisdiction with the label. An FDA Class II and a Health Canada Type II are regulator-specific terms, so MedWatcher shows the agency alongside the classification.

Use the official notice for the next step

Open the linked official notice and first check the model, lot, serial range, or other identifier it names. Then read the action stated by the regulator or recalling firm.

Do not change prescribed care based on a classification alone. If the notice could affect a device you rely on, contact the clinician or supplier responsible for that device.

A recall classification does not establish that your own device is affected.