Class I, II and III Medical Device Recalls: What They Mean
Last reviewed Oct 16, 2026 · Based on FDA sources listed below · Editorial policy
When a problem is found with a device, the company usually starts the recall itself. The FDA then classifies the recall by how serious the health risk is.
The three classes
- Class I — the most serious. There is a reasonable probability that using the device will cause serious health problems or death.
- Class II — the device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Class III — using the device is not likely to cause health problems, but it violates FDA rules (for example a labeling error).
The class describes how serious the problem is, not how many devices are affected.
A recall is not always a removal
Many device recalls are corrections: the device stays where it is and is fixed in place — a software update, a new label, updated instructions or an inspection. A removal means the device is taken back. Both are recalls.
What the status means
- Open — the recall is still in progress.
- Terminated — the FDA has determined that all reasonable efforts have been made to remove or correct the affected devices.
- Classified / not yet classified — whether the FDA has assigned a class yet.
What to do
The class tells you how serious the problem is; the recall notice tells you what to do. Read what the company is doing in the recall record, check whether your unit is included, and talk to your healthcare provider before changing how you use the device.
This guide explains public FDA information. It is not medical advice — talk to your healthcare provider about decisions involving your device.
Sources
- 21 CFR Part 7 — Enforcement policy (recall classification, termination) ↗
- 21 CFR Part 806 — Medical devices; reports of corrections and removals ↗
- FDA Medical Device Recalls database ↗