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This page describes products and general use; it is not medical advice.
A glucose meter recall can be announced in several places at once, and the record that matches your meter may not mention lot numbers at all. This guide shows where an FDA glucose meter recall appears, how the records fit together, and how to check a meter against them, using the 2026 TRUE METRIX Class I recall as a worked example. It is written for clinic and pharmacy staff, supply buyers and students who need to confirm whether a specific meter is affected.
What counts as a glucose meter recall
A recall is a firm’s action to address a problem with a device, and FDA classifies it by risk. For the 2026 TRUE METRIX action, FDA states it “identified this recall as Class I, the most serious type.” The TRUE METRIX action shows that a recall can concern a meter’s software design and its printed or online instructions rather than a hardware fault. FDA’s recall notice says the issue is “with the E-5 error code and the instructions for the user” in the owner’s booklet messages section and the online labeling and help guides. For the general classes of device recall, see medical device recall.
Where FDA announces a glucose meter recall
For the TRUE METRIX recall, the same event is findable in five places. Each answers a different question.
| Where | What it tells you |
|---|---|
| FDA recall notice (medical device recalls and early alerts) | Which products are affected, why, the class, and the firm’s contact details. The page says it updates an earlier Early Alert (issued 02/17/2026). |
| FDA Safety Communication (April 28, 2026) | FDA’s own recommendations for patients, caregivers and health care providers, and a link to the full list of affected products. |
| FDA Enforcement Report | The recall entry in FDA’s Enforcement Report. See FDA enforcement reports for how to search it. |
| CDRH Medical Device Recall Database | The structured record: recall number, event ID, product code, 510(k) number, cause, action taken, quantity and distribution. |
| The firm’s notice page and correction letters | The firm’s letters (02/06/2026 and updated 05/01/2026), the list of impacted products and, per the database record, an affected serial number search tool. |
How to check a meter step by step
- Record the manufacturer and model from the label. FDA’s notice covers named systems (TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO and TRUE METRIX PRO) and says this includes “cobranded products sold under store or distribution partner names,” so the brand on the box may not be the manufacturer’s.
- Find the unique device identifier (UDI) if one is printed. FDA’s pages point to its guidance on recognizing a UDI on a label and to the AccessGUDID database, which identifies a device from its identifier.
- Search the recall notice and the CDRH recall database by manufacturer or product name, then open the record and note the event ID. In the TRUE METRIX case that ID is 98317 and the recall number is Z-1548-2026.
- Read the affected-products list attached to the notice and compare model names and catalog numbers. Do not rely on the headline alone.
- Check the identifier the record actually uses. In the TRUE METRIX database record, lot numbers are listed as “Not listed” and the serial numbers are described as the prefix “F” followed by an eight-digit number. A lot-number search would therefore find nothing, which is why model, catalog number, UDI and serial prefix are the fields to match.
- Read the firm’s letter and FDA’s communication for the instructions given there. This page does not replace them.
Worked example: the 2026 TRUE METRIX Class I recall
Sources: FDA Safety Communication (April 28, 2026), FDA recall notice, and the CDRH recall database record for TRUE METRIX GO, all checked 2026-11-01.
| Record field | Value in the record | What it tells you |
|---|---|---|
| Class | Class 1 | FDA’s most serious recall class. |
| Recall number / event ID | Z-1548-2026 / 98317 | Keys that tie the database record to the Enforcement Report entry. |
| Status | Open, Classified | The action was not closed when the record was read. |
| 510(k) number / product code | K143548 / NBW (over-the-counter blood glucose test system) | Links the meter to its FDA clearance and device category. |
| Product | Owner’s booklets and instructions for use for the meters and kits, with catalog numbers listed | Match catalog numbers, not only the brand name. |
| Lots / serial numbers | Lots “Not listed”; serial prefix “F” plus eight digits | Lot-based matching does not work for this event. |
| FDA-determined cause | Software design | The recall concerns the E-5 error code and the instructions given for it. |
| Action | Correction notices 2/6/2026; updated notices mailed 5/5/2026; retailers and facilities asked to post notices | The notices and labeling are part of the recall. |
| Quantity in commerce | 1,407,465 | Scale of distribution. |
| Distribution | US nationwide including Puerto Rico; Mexico, United Kingdom, Jamaica, Trinidad & Tobago, Australia | The recall is not limited to the US market. |
FDA’s communication reports that, as of January 16, 2026, the firm had reported 114 serious injuries and one death associated with this issue. The communication also lists FDA’s recommendations for patients, caregivers and health care providers; read them in full at the source.
What facilities should record
FDA’s recommendations for health care providers include notifying patients who use affected devices and, for facilities with multiple patients, posting the communication where the products are stored. A facility can keep a short record for each recall it acts on: the event or recall number, the models checked, the date the notice was read and who was told. For tracking supplies against notices, see medical inventory tracking and FDA recall coordinator.
Common mistakes
- Searching only by lot number. In this record, lots are not listed.
- Assuming a store-brand meter is unaffected. FDA says co-branded products are included.
- Assuming a recall means a hardware fault. This one concerns software design and instructions.
FAQ
How do I know if my glucose meter is part of a recall?
Match its manufacturer, model, catalog number, UDI or serial number against the affected-products list in the FDA recall notice and the CDRH recall database record, then read the firm’s letter. For TRUE METRIX the record lists serial numbers beginning with “F” plus eight digits.
Where does FDA publish a glucose meter recall?
On its medical device recalls and early alerts page, in a Safety Communication where FDA issues one, in the Enforcement Report and in the CDRH Medical Device Recall Database.
Can a recall be about instructions rather than a broken meter?
Yes. FDA’s 2026 TRUE METRIX recall concerns software design of the E-5 error code and the instructions given for it in the labeling.
How can a problem be reported?
FDA says consumers can use the MedWatch Voluntary Reporting Form, and staff of facilities subject to FDA’s user facility reporting requirements should follow their facility’s procedures.
Related reading: what a glucometer is, glucose blood test strips and glucose control solution.
Sources
- FDA, Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication, issued April 28, 2026; checked 2026-11-01.
- FDA, Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems; checked 2026-11-01.
- FDA CDRH, Medical Device Recall Database record, Z-1548-2026; checked 2026-11-01.
