Medical Device Recall: Classes, Actions and Records to Keep

This page describes products and general use; it is not medical advice.

A medical device recall is a correction or removal action taken to address a problem with a medical device that violates FDA law. It does not automatically mean a device must be thrown away or sent back: many recalls ask a facility to check, adjust or repair the product. This guide is for clinic staff, supply buyers and students who need to read a recall notice correctly and know which records to keep.

What is a medical device recall?

According to the FDA, a recall is a correction or removal action to address a problem with a medical device that violates FDA law. FDA states that a recall does not always mean you must stop using the product or return it to the company; sometimes the device needs to be checked, adjusted or fixed. When a company cannot tell which individual units are affected, it may recall an entire lot, model or product line. That is why lot numbers matter (see how to read a lot number).

Correction vs removal

FDA’s recall pages separate two kinds of action, and a notice from a manufacturer will describe one of them.

Action	FDA’s description	What it can look like at a facility
Correction	Repair, modification, adjustment, relabeling, destruction or inspection of a device	Device stays in service after it is inspected, adjusted, repaired or relabeled as the notice directs
Removal	Physical removal of a device from its point of use to some other location	Device is taken out of use and moved, as the notice directs

Source: FDA, Recalls, Corrections and Removals (Devices), checked 2026-11-01.

Class I, II and III

After FDA reviews a company’s action, it assigns a classification that indicates the relative degree of risk.

Class	FDA’s description
Class I	A reasonable chance that the product will cause serious health problems or death
Class II	The product may cause a temporary or reversible health problem, or there is a slight chance of serious health problems or death
Class III	The product is not likely to cause any health problem or injury

Source: FDA, What is a Medical Device Recall?, checked 2026-11-01. The class describes risk, not the action required; the notice itself says what to do.

Who starts and reports a recall?

In most cases a company (manufacturer, distributor or other responsible party) recalls a device voluntarily, starts the correction or removal and notifies FDA. FDA can require a recall, but says it has rarely needed to. Device recalls are usually voluntary under 21 CFR Part 7, and 21 CFR Part 810 sets out the procedures FDA follows when it uses its device recall authority.

Reporting duties sit with the firm. Under 21 CFR 806.10, manufacturers and importers submit a written report of a correction or removal initiated to reduce a health risk or to remedy a violation that may present one, generally within 10 working days. The report includes the device name, unique device identifier (UDI), lot or serial numbers, a description of the event and actions, and the names, addresses and quantities of all consignees, with copies of the communications sent. A facility is not the reporting party, but it is a consignee, and the manufacturer relies on distribution records to reach it.

Where to find recall information

• The FDA Medical Device Recall Database, where recalls are posted.
• The weekly FDA Enforcement Report, which covers recalls, field corrections, seizures and injunctions; see FDA enforcement reports for how to search it.
• FDA’s separate page of Medical Device Class I recalls.

A real example of a recall that reached clinical supply shelves is covered in the Broselow tape recall guide.

What a facility should keep to act on a recall

Because notices identify devices by lot, serial number or UDI, and the manufacturer’s report lists consignees, a facility can only check its own stock if it holds matching records. This checklist is editorial, derived from the report contents above, not an FDA requirement for facilities.

• Lot or serial number and UDI for each device or box received (UDI explained).
• Purchase and receiving records naming the supplier and quantities, so the facility can show it is a consignee.
• Where each device was sent within the facility, for tracked devices (device tracking requirements).
• The recall notice itself and a record of what was checked, adjusted, repaired or returned.
• Any related adverse event handling (medical device reporting).

Common mistakes

• Assuming every recall means stop use and return. FDA says it does not always.
• Reading the class as the instruction. The class reflects risk; the notice states the action.
• Treating a recall as only the manufacturer’s job. The firm initiates and reports, but it can only reach a facility whose purchase records are traceable.

FAQ

Does a medical device recall mean I must stop using the device?

Not always. FDA states a recall does not always mean you must stop using the product or return it; it may need to be checked, adjusted or fixed. Follow the specific notice.

Who recalls a medical device?

Usually the manufacturer, distributor or other responsible party, voluntarily, followed by notice to FDA. FDA can require a recall but has rarely needed to.

How quickly must a recall be reported to FDA?

Under 21 CFR 806.10 the written report is due within 10 working days of the firm initiating the correction or removal, unless it is already reported under other parts or exempt.

Sources

• FDA, What is a Medical Device Recall?, checked 2026-11-01.
• FDA, Recalls, Corrections and Removals (Devices), checked 2026-11-01.
• eCFR, 21 CFR 806.10, Reports of corrections and removals, checked 2026-11-01.