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

Short Answer: What to Get in Writing Before You Rely on a Used Medical Device

Before you rely on a used medical device, ask for three sets of records in writing: its cleaning history, its calibration or service history, and who has owned it. Then check the exact model against the FDA's recall and safety lists. Neither FDA source used for this guide gives a step-by-step method for cleaning or calibrating a used device, so the checklist below is a set of questions to ask, not an FDA procedure.

By SIGMedical.net Editorial Team. Updated: September 24, 2026.

Red Flags First

If someone is having a medical emergency, call your local emergency services right away. Do not stop to look up records.
If a device was prescribed for you, talk with the clinician who prescribed it before you change how you use it or swap it for a different unit.
If a used device seems to be working wrongly, contact your prescriber or the manufacturer promptly and ask what to do.
If a seller cannot or will not share basic records, ask more questions before you rely on the device.

Terms to Know

Terms defined by the FDA sources:

Recall: The FDA uses this word when a manufacturer takes a correction or removal action to address a problem with a device that violates FDA law. Recalls happen when a device is defective, when it could be a risk to health, or both.
Safety communication: The FDA posts these to describe its analysis of a current issue. They also give specific regulatory approaches and clinical recommendations for patient management.
Registration and listing: Businesses that make and distribute devices for use in the United States are generally required to register with the FDA each year. The FDA says a registration entry does not mean a facility or its devices were approved, cleared, or authorized.
Approved, cleared, or authorized: These are the FDA's actual review outcomes. The FDA points to its Devices@FDA database for approved and cleared products, its De Novo database for certain new low- to moderate-risk device types, and its Emergency Use Authorization page for products authorized during declared emergencies.
MedWatch: This is the FDA's program for reporting a problem with a medical device. You can file a voluntary report online or by phone at 1-800-332-1088.

Working definitions used in this guide (not FDA definitions):

Cleaning record: A written note of who cleaned the device, when, and by what method.
Calibration record: A written note showing when a device's accuracy was checked or adjusted, by whom, and with what result. Ask the manufacturer or your clinician whether your device needs calibration at all.
Ownership record: A written history of who has owned or used the unit, and where. For example, a home, a clinic, or a rental fleet.

Comparing the Claims and Papers You May See

What the FDA sources support:

“FDA registered” or “FDA certified”: The FDA says these words may be used to mislead. It does not issue device registration certificates. It says firms that display misleading certificates to imply FDA review or approval misbrand the device.
A Devices@FDA entry: This shows whether a device product has been approved or cleared. Our plain reading is that it describes the product, not the history of the one unit you are holding.
A recall or safety communication: These describe problems with particular products. The FDA's safety communications list, current as of June 3, 2026, includes items on blood glucose monitoring systems, blood pressure monitors, and patient monitors. Always check by exact brand and model.

What the sources do not cover:

A seller's cleaning statement: The FDA pages we used do not say how to judge one. Treat it as unverified until it is written down and matches the manufacturer's instructions for your model.
A calibration certificate: The same limit applies. Ask who did the work and what the results were.
Ownership history: Nothing in these sources sets a standard for what a used-device ownership record should contain. The questions below are our own practical framework.

Step-by-Step Field Guide

Steps 1, 2, 3, and 9 use FDA resources. Steps 4 through 8 are our own practical framework, not FDA requirements.

Write down the identifiers. Copy the brand, model name, model number, and serial number exactly as printed on the device label. Take a photo of the label.
Search Devices@FDA. Type the device name or company name into the Devices@FDA database. If you find nothing, ask the seller and your clinician.
Check recalls and safety communications. Review the FDA safety communications list and the FDA recalls page for your model. The FDA also offers email updates on device recalls and safety information.
Ask for the cleaning history in writing. Ask who cleaned it, when, and which instructions or products they used. Ask whether those match the manufacturer's instructions for that model.
Ask for calibration or service records. Ask for the dates, who did the work, and the results. Also ask whether any parts were repaired or replaced.
Ask for the ownership history. Ask how many owners there have been and how the device was used. Ask whether it was ever affected by a recall, and what happened when it was.
Confirm the seller and the terms. Get the seller's name and contact details in writing. Ask about any return or refund terms before you rely on the device.
Talk with a clinician when the device affects health decisions. Bring the model, the serial number, and the records you collected.
Report problems. If you have a problem with a device, the FDA encourages voluntary reports through MedWatch.

Records Worksheet

Brand, model, and serial number: ______
Devices@FDA result (found, not found, notes): ______
Recall and safety communication check (date checked, result): ______
Cleaning: who, when, method, and the source of the instructions: ______
Calibration or service: date, who, results, and repairs: ______
Owners and prior use: ______
Seller name, contact, and return terms: ______
Questions for my clinician: ______

Questions to Bring to a Clinician or the Manufacturer

Is this device type appropriate for my situation, and is a used unit acceptable?
Does this model need calibration? If so, how often, and who should do it?
Which cleaning instructions apply to this model?
Are there recalls or safety communications for this exact model or serial number range?

What We Could Not Verify

The two FDA pages named for this guide cover recalls, safety communications, consumer topics, and reporting. They do not set out cleaning or calibration steps for used devices. The FDA's consumer hub was current as of August 3, 2026, and its safety communications list as of June 3, 2026. Check the FDA pages again for newer notices before you decide anything.

Sources and Our Process

U.S. Food and Drug Administration, Consumers (Medical Devices)
U.S. Food and Drug Administration, Medical Device Safety Communications
U.S. Food and Drug Administration, Are There “FDA Registered” or “FDA Certified” Medical Devices?

Our review process is described in our Editorial Policy. You can also see How We Review.

Educational Disclaimer

This article is general educational information. It is not medical advice, diagnosis, or treatment, and it does not recommend any device, seller, or service. Talk with a qualified healthcare provider about any device that affects your care. See our Medical Disclaimer. SIGMedical.net is an independent editorial publication. It has no affiliation with SIG Medical Inc., Zimmer Biomet, Penn State Health, or any former entity associated with this domain. See our Non-Affiliation Notice.

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