Finding a Medical Device Recall: Model, Lot, and Serial Number

To check whether a recall may cover your medical device, first write down the device name, the company, and any model, lot, serial, or UDI numbers on its label or package. Then search the FDA's Medical Device Recall Database by product name or company and compare your numbers to the record's “Code Information” field. If you can't confirm a match either way, ask the recalling company or your health care provider before you make any change.

If Something Is Wrong Right Now

If a device problem is causing a medical emergency, contact your local emergency services first. Looking up a recall can wait.

If you have had a problem with a medical device, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program, online or by phone at 1-800-332-1088. For questions about your own care, contact your health care provider.

What a Medical Device Recall Means

According to the FDA, a recall happens when a manufacturer takes action to address a problem with a medical device that violates FDA law. That can mean the device is defective, could be a risk to health, or both. (FDA: What Is a Medical Device Recall?)

The FDA describes two kinds of recall action:

Correction: the problem is fixed where the device is used or sold.
Removal: the device is taken away from where it is used or sold.

The FDA says a recall “does not always mean that you must stop using the product or return it to the company.” Sometimes the device only needs to be checked, adjusted, or fixed. For implanted devices, the FDA notes that companies usually ask doctors to contact their patients. The doctor and patient then talk through the risks of removing the device compared with leaving it in place.

Recall Classes in Plain Language

The FDA puts recalls into three classes based on risk:

Class I: there is a reasonable chance 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.

The Numbers That Identify Your Device

A brand name alone may not tell you enough. Identifying numbers let you compare your exact device with the products a recall record describes. In plain terms:

Model (or version): which design of the device you have.
Lot or batch number: the production group your device came from.
Serial number: a number assigned to one individual device.

How the Unique Device Identifier (UDI) Fits In

Many devices carry a unique device identifier, or UDI. The FDA describes it as a unique numeric or alphanumeric code that identifies a device. A UDI has two parts (FDA: UDI Basics):

Device identifier (DI): the fixed part. It identifies the labeler (the company responsible for the label) and the specific version or model of the device.
Production identifier (PI): the part that changes from unit to unit. When it appears on the label, it can include the lot or batch number, serial number, expiration date, or manufacture date.

Under FDA rules, the UDI goes on device labels and packages, with some exceptions and alternatives. It appears in plain text you can read, plus a machine-readable form using automatic identification and data capture (AIDC) technology, meaning a format that a computer system can read automatically. Some devices that are reused and reprocessed must also have the UDI marked directly on the device. You can search the public AccessGUDID database by device name, company, or device identifier.

Evidence Ladder: Where to Look, From Most to Least Specific

A recall notice sent to you or your provider. If you receive a letter or call about a device, keep the notice and write down any identifiers and contact details it gives.
The FDA Medical Device Recall Database. The database covers recalls the FDA has classified since November 2002. You can search by product name, product code, recall class, recalling firm, recall date, reason for recall, and FDA premarket (510(k) or PMA) number. Each record includes fields such as Product, Code Information, Manufacturer Reason for Recall, Action, and For Additional Information Contact.
FDA recall and safety pages. The FDA publishes medical device recall listings and Medical Device Safety Communications. Safety communications are notices where the FDA describes its analysis of a current device issue and gives recommendations.
General news or social media posts. These can tell you to look into something. Confirm the details with the sources above before acting on them.

Two database details are easy to misread:

The “Code Information” field varies. It lists identifying codes for the affected products, but not always in the same format. For example, one infusion pump record we reviewed listed product codes and battery codes rather than lot or serial numbers. If you can't tell whether your numbers match, use the record's “For Additional Information Contact” details.
The posting date is not the start date. According to the FDA, a record's “create date” is the date the FDA classified the recall. It does not necessarily mean the recall is new, because the company may already have contacted its customers.

What You Can Confirm vs. What You May Need Help With

Usually possible on your own

The device name and manufacturer, from the label or packaging
Any model, lot, serial, or UDI numbers printed on the label or package
Whether the FDA database lists a recall for that product name or company
The recall's class, stated reason, and listed action

Often needs help from the company or your care team

Whether your exact unit is affected, when the numbers are missing, unreadable, or on packaging you no longer have
Identifying details for an implanted device, which may need to come from your care team
Whether the right step for you is to keep using, adjust, repair, return, or remove the device. The FDA says this varies by recall, and for implants it depends on a conversation with your doctor.
Actions the company started that the FDA has not classified or posted yet

Practical Next-Step Checklist

Write down the basics: device name, manufacturer, and when and where you got it.
Find the numbers: copy any model, lot, serial, or UDI numbers from the label or packaging. Take a clear photo as a backup.
Look up the device identifier: if you have a UDI, you can search AccessGUDID by device identifier, device name, or company.
Search the FDA Recall Database: try the product name first, then the company name if nothing comes up.
Compare carefully: check the record's Product and Code Information fields against your numbers.
Note the class, reason, and action: these help you decide how quickly to follow up.
Ask before making changes: a recall does not always mean you must stop using a device. Contact the recalling company or your health care provider for instructions that fit your situation.
Keep a record: save notices, photos, and notes from any calls.
Report problems: if you have had a problem with the device, you can report it through MedWatch.
Stay informed: the FDA offers email updates on medical device recalls and safety communications.

Questions to Bring to Your Provider or the Recalling Company

Does this recall cover my model, lot, serial, or other product code?
Is this a correction (the device is checked or fixed) or a removal?
Should I keep using the device while this is sorted out, and what warning signs should I watch for?
If the device is implanted, what are the risks of leaving it in place compared with removing it?
Where can I find my device's identifying numbers if I can't locate them myself?

Sources and Editorial Notes

By SIGMedical.net Editorial Team. Last updated: September 24, 2026.

This guide is based on FDA public resources: Consumers (Medical Devices), Medical Device Safety Communications, What Is a Medical Device Recall?, the Medical Device Recall Database, and UDI Basics. To learn how we choose and check sources, read our Editorial Policy.

SIGMedical.net is an independent editorial publication. As explained in our Non-Affiliation Notice, we are not affiliated with, endorsed by, or connected to SIG Medical Inc., Zimmer Biomet Holdings Inc., or any other entity previously associated with this domain. We are also not affiliated with the FDA.

This article is general educational information, not medical advice. It does not diagnose conditions or recommend treatment, and it cannot tell you whether a specific recall applies to your device. For decisions about a medical device you use, talk with a qualified health care provider or the device's manufacturer. In an emergency, contact your local emergency services.

Next up

Medical Device Recalls: How to Match a Notice to the Model You Own

Replacing Medical Device Accessories: Compatibility and Safety Checks

Medical Device Clearance Versus Approval: A Consumer Guide

A Used Medical Device: Cleaning, Calibration, and Ownership Records