FDA Device Recall Classes: Class I, II and III Explained

FDA device recalls come in Class I, II and III. Here is what each means, who reports what and when, and how to read a recall entry like Tandem’s Mobi pump.

Last updated: November 12, 2026

Quick answer: FDA sorts medical device recalls by health risk. Class I means a reasonable probability of serious harm or death, Class II means temporary or medically reversible harm, and Class III means harm is unlikely. The firm usually starts the recall; FDA assigns the class.

Scope: how US device recalls are classified, reported and closed, written for regulatory, quality and commercial teams, using FDA’s own definitions and the current Tandem Mobi recall as a worked example.

What are the three FDA recall classes?

FDA defines three recall classes by the health hazard a violative product poses. The class reflects risk, not how many units are involved or how the company chose to fix the problem.

Class	FDA definition (paraphrased)	Typical example pattern	Public warning?
Class I	A reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death	Insulin delivery faults, life support failures, implant malfunctions	FDA generally recommends one
Class II	The product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote	Labeling errors, performance issues with workarounds	Case by case
Class III	Use of or exposure to the product is not likely to cause adverse health consequences	Minor labeling or packaging violations	Rarely

Table: BioMed Nexus, from FDA’s “Recalls Background and Definitions” and “Recalls, Corrections and Removals (Devices)” pages. Example patterns are our illustration, not FDA categories.

FDA’s CDRH training material says the agency “generally recommends public warning for recalls that are likely classified as Class I.” FDA’s device page adds that public warnings are “reserved for urgent situations.”

Who decides the class of a device recall?

FDA does. The company initiates and runs the recall, but FDA conducts a health hazard evaluation and assigns the class based on its result.

According to FDA, the evaluation weighs factors such as whether injuries have already occurred and the likelihood and seriousness of the hazard. That is why a database entry can be posted weeks after the firm acted: the recall started when the company sent notices, and the class came later.

Is a recall the same as a correction or removal?

Not quite. A recall is a correction or removal of a marketed product that FDA considers violative and against which it would initiate legal action. Correction and removal describe how the fix happens.

Correction: fixes the problem where the device is used or sold, such as a software patch, relabeling or new instructions.
Removal: takes the device out of where it is used or sold.

So a “recall” can mean pumps stay in patients’ hands with new instructions. That surprises people outside regulatory. The Tandem Mobi action below went out as an urgent medical device correction, and users were told to keep using the pump.

What is not a recall?

FDA lists several actions that fall outside the recall definition. Knowing them prevents both over reporting and under reporting.

Market withdrawal: a minor violation that would not be subject to FDA legal action, or no violation at all.
Stock recovery: product that never left the firm’s direct control.
Routine servicing.
Product enhancement: a change that improves performance or quality and is not tied to a violation. FDA’s final October 2014 guidance on distinguishing recalls from enhancements says the key factor is whether a violation of the FD&C Act or its regulations exists.

When must a device company report a correction or removal to FDA?

Within 10 working days of starting it, if the action addresses a risk to health. That is the 21 CFR Part 806 rule, and only the firm that initiates the correction or removal has to report.

FDA’s device recall page lists the main exemptions: actions taken only to improve performance or quality without reducing a risk to health, market withdrawals, routine servicing and stock recoveries. No separate report is needed if the information was already submitted under the Medical Device Reporting rule (Part 803), or if an FDA recall order started the action. Extending a correction to more lots requires an amendment, also within 10 working days.

Records must be kept for two years beyond the expected life of the device, per FDA.

Can FDA force a device recall?

Yes, though it rarely does. Most device recalls are voluntary under 21 CFR Part 7. Under Section 518(e) of the FD&C Act and 21 CFR Part 810, FDA can issue a cease distribution and notification order and then a mandatory recall order when a firm will not act on a device that is a risk to health.

The named firm gets an opportunity for a regulatory hearing. If a firm refuses to recall, FDA’s training material lists other tools: injunction, import alert, foreign country notification and seizure.

How does a recall run from start to finish?

The firm builds a recall strategy, FDA classifies and monitors it, and FDA terminates it when all reasonable efforts have been made. Here is the sequence with the levers FDA describes.

Step	What happens	Key detail from FDA
1. Initiation	Firm notifies customers and starts the correction or removal	Part 806 report due within 10 working days if there is a risk to health
2. Strategy	Firm sets depth, communications and checks	Depth: consumer or user, retail or wholesale level
3. Classification	FDA health hazard evaluation	Assigns Class I, II or III
4. Effectiveness checks	Confirm consignees got and acted on the notice	Level A (100%), B (more than 10% and less than 100%), C (10%), D (2%), E (none)
5. Status reports	Firm reports progress	Generally every 2 to 4 weeks
6. Termination	FDA closes the recall	Firm may request it in writing with the final status report

FDA’s recall strategy factors include the health hazard result, ease of identifying the product, how obvious the deficiency is to users, how much unused product remains in the market and the continued availability of essential products.

What is an FDA Early Alert?

An Early Alert is FDA telling the public about a potentially high risk correction or removal before it has finished classifying it. The goal is to shrink the time between FDA learning of the problem and public communication.

FDA announced the pilot November 21, 2024 and expanded it to all medical devices on September 29, 2025. FDA notes an Early Alert may go out before the agency has determined that the company’s action meets the regulatory definition of a recall. Entries move from “Early Alert” status to “Recall Confirmed” once classified.

For commercial teams this is the practical change: the public, competitors and reporters can now see a likely Class I action before FDA finishes classifying it.

How do you read a recall entry? The Tandem Mobi example

Take the current Tandem Diabetes Care Mobi insulin pump recall. FDA’s database lists it as a Class 1 device recall, recall number Z-0316-2027, initiated by the firm September 23, 2026, posted October 30, 2026, with status “Open, Classified.”

In this case about five weeks passed between initiation and FDA posting the classified entry. The entry also carries FDA’s standard footnote that the manufacturer has initiated the recall and not all products have been corrected or removed.

The entry lists 80,938 pumps in commerce (77,559 US, 3,379 outside the US). The stated reason: increased friction within the drive module can reduce available motor power, so the pump may generate false positive occlusion alarms when no real obstruction exists and suspend insulin until the user responds. FDA lists the cause as process change control. A Tandem spokesperson told MedTech Dive there were 230 adverse events requiring medical intervention or hospitalization as of October 29, and no deaths.

Per the FDA entry, customers were told to continue using the pump, always respond to occlusion alarms using the user guide steps, enable push notifications in the Mobi app, be prepared with a backup insulin method and contact Tandem if alarms are frequent. Pumps with serial numbers showing frequent false alarms are listed for exchange. In other words, a Class I correction, with targeted exchanges rather than a field wide removal.

It is not Mobi’s first Class I entry. FDA’s database also lists a February 2025 Class 1 recall tied to a software defect in version 7.9 of the t:slim X2 and Mobi pump software that could cause under or over delivery of insulin. That action covered 85 units, and users were told to turn off Control-IQ+.

The contrast is the lesson: one Class I entry covered 85 pumps, the other 80,938. Class tells you severity of the hazard, not scale. Read the quantity line before drawing commercial conclusions.

Our framework: a recall readiness checklist

BioMed Nexus framework: seven questions to answer before your next field action

Is there a violation? Decide recall versus enhancement on the record, using FDA’s 2014 guidance, before anything ships.
Is there a risk to health? If yes, the Part 806 clock starts the day you initiate. Ten working days goes fast.
Correction or removal? Can users safely keep the device with new instructions, or does it have to come back?
What depth? User level for anything patient facing. Know your consignee list and its data quality.
How will you prove effectiveness? Plan for Level A checks on anything that could be Class I.
Are you Early Alert ready? Assume FDA may go public before classification. Have customer, investor and press statements drafted.
How does it close? Map the status report cadence and the evidence FDA will want to terminate.

What to watch next

Tandem’s next steps on Mobi, including any hardware or software change and whether the action converts to a removal.
How often FDA’s Early Alert entries become confirmed Class I recalls now that the program covers all devices.
Any FDA update to its recall guidance or the enhancement guidance, which dates to 2014.

FAQ

What is a Class I medical device recall?

It is FDA’s most serious recall category: a reasonable probability that using or being exposed to the device will cause serious adverse health consequences or death.

What is the difference between Class I, II and III recalls?

Class I means serious harm or death is reasonably probable, Class II means harm is temporary or medically reversible or serious harm is remote, and Class III means harm is not likely.

Does a Class I recall mean the device must be returned?

No. Many Class I recalls are corrections, such as new instructions or software changes, and the device stays in use. The Tandem Mobi action is a Class I correction.

Who classifies a medical device recall?

FDA classifies it after a health hazard evaluation. The company usually starts and runs the recall itself.

How long does a company have to report a device correction to FDA?

Ten working days from initiating a correction or removal that addresses a risk to health, under 21 CFR Part 806.

Can FDA order a medical device recall?

Yes. Under Section 518(e) of the FD&C Act and 21 CFR Part 810, FDA can order a recall when a firm fails to voluntarily recall a device that is a risk to health. It does so rarely.

What is the difference between a recall and a market withdrawal?

A market withdrawal involves a minor violation that would not be subject to FDA legal action, or none at all. A recall involves a violation FDA would act on.

What is an FDA Early Alert for medical devices?

A public notice about a potentially high risk correction or removal, issued before FDA finishes classifying it. The program has covered all devices since September 29, 2025.

Why is a recall posted weeks after the company acted?

Because FDA posts the classified entry after its health hazard evaluation. Tandem started its Mobi action September 23, 2026 and FDA posted it October 30.

What are recall effectiveness check levels?

FDA levels run from A (100% of consignees contacted) through B, C (10%) and D (2%) to E (no checks). The firm proposes the level in its recall strategy.

When is a recall terminated?

When FDA finds all reasonable efforts have been made to remove or correct the product under the recall strategy. The firm can request termination in writing.

Sources

FDA, Recalls, Corrections and Removals (Devices) (primary): https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
FDA, Recalls Background and Definitions (primary): https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
FDA, What is a Medical Device Recall? (primary)
FDA, What is an Early Alert? (primary): https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/what-early-alert
FDA, Distinguishing Medical Device Recalls from Medical Device Enhancements, final guidance, October 2014 (primary)
FDA CDRH Learn, Introduction to Medical Device Recalls (primary, training material): https://www.fda.gov/media/181441/download
FDA Medical Device Recalls database, Tandem Mobi, Z-0316-2027 (primary): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222734
FDA Medical Device Recalls database, Tandem Mobi Insulin Pump with Interoperable Technology, Z-1520-2025 (primary): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=212817
MedTech Dive, “Tandem recalls Mobi insulin pump, reports 230 adverse events,” November 11, 2026 (attributed: adverse event count via company spokesperson)

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