The Nova Biomedical StatStrip recall listing that the FDA published on 20 October 2026 concerns one model of hospital glucose meter and one specific risk: patient or quality-control barcode information from a previous scan can remain on the screen, so a glucose result may be filed under the wrong patient. The FDA calls it a removal, the most serious type of recall, and warns that the device may cause serious injury or death if use continues. It affects only the StatStrip Gen 2.0 meters, not the earlier Gen 1.86. The item is newly listed by the FDA, but the manufacturer first told customers on 31 July and updated its advice on 5 October, so it is not a newly started recall.
Nova Biomedical StatStrip recall: key takeaways
- The affected products are the StatStrip Glucose Hospital Meter System, Model 63685, and the Multipack, Model 66739, in the Gen 2.0 version on all firmware versions, per FDA’s notice.
- The earlier Gen 1.86 meter is not included, and this is not a recall of all StatStrip meters.
- The risk is a result assigned to the wrong patient or quality-control record, not a measurement error: Nova says analytical accuracy is not affected.
- As of 5 October, Nova reported one serious injury and no deaths.
- A software update is planned for a phased rollout from November 2026; Nova recommends removing affected meters from use until it is available.
What the Nova Biomedical StatStrip recall listing says
The FDA page, published 20 October, describes a removal, meaning devices must be taken out of use or sale, and says it is the most serious type of recall. General background: the FDA’s most serious category, Class I, is used where use of a device may cause serious injury or death. The page we reviewed does not use the words Class I, and we repeat the agency’s own description. The listing identifies two products, Model 63685 and Model 66739, which share the unique device identifier 00385480636858, and lists no serial or lot numbers or total quantity.
Why the Nova Biomedical StatStrip recall is not new
The FDA’s page reflects steps the manufacturer took earlier. Nova sent its initial customer letter on 31 July, issued an updated letter and a press release on 5 October, and the FDA published its page on 20 October. Readers should therefore treat the listing as a newly surfaced item in the agency’s current recall list and not as a recall begun today. The distinction matters for hospitals trying to confirm what actions were already due.
The patient-ID problem behind the Nova Biomedical StatStrip recall
According to the FDA, when an operator scans a patient ID or quality-control barcode on a Gen 2.0 meter, information from a previous scan can stay on the screen. If the operator accepts it, the glucose result can be filed under the wrong patient or quality-control ID. Nova says the issue does not affect the accuracy of the glucose measurement itself. The FDA says possible harms include delayed treatment, unnecessary treatment including inappropriate insulin, and failure to treat the intended patient, with critically ill patients and infants at greater risk.
Why a wrong-patient glucose result matters
This section is general background. Glucose readings guide decisions about insulin and other treatment, so a value attached to the wrong record can lead one patient to receive too much or too little treatment and another to be missed. In hospitals, results usually flow straight into the electronic record, which is why a labelling error can matter even when the number itself is correct. The FDA notice stresses checking the patient ID on screen after each scan.
What to do during the Nova Biomedical StatStrip recall
- If the hospital record system uses admission, discharge and transfer data, enable the Validate Patient IDs setting in NovaNet.
- Set the operator logoff mode to Test so that the operator logs out after each test.
- Check the patient ID on screen after each scan, before accepting it, and again on the result screen.
- If a result goes to the wrong patient, tell the administrator immediately, flag or remove the result, follow facility procedures to correct the record and promptly tell the treating team.
- If an alternative device is available, stop using the affected meter; otherwise continue these steps until the fix arrives.
Nova has also placed a shipment hold on all new Gen 2.0 meters and is developing and validating a software update, which it says includes other non-safety improvements. Customers can contact Nova Biomedical at 1-800-545-6682 in the United States.
Removal versus a recall of all meters
The action covers Gen 2.0 only, and the FDA notice states that the earlier Gen 1.86 model is not included. Hospital teams should check which model they use before acting. Our reading is that the term removal here means taking affected meters out of use or sale until a fix is installed, and not necessarily that every meter must be returned or destroyed, but the FDA page and Nova’s customer letter are the authority for the exact steps.
What the Nova Biomedical StatStrip recall does not disclose
- The number of meters affected.
- The exact date the software update will reach each customer.
- Details of the reported complaints beyond the single serious injury.
Risks and caveats on the Nova Biomedical StatStrip recall
- We rely on the FDA page and have not seen the manufacturer’s customer letter.
- Our general background on Class I and glucose treatment is not from the FDA notice.
- Hospitals should follow the FDA and manufacturer instructions, not this summary.
- This is news reporting, not medical or regulatory advice.
In our assessment, the Nova Biomedical StatStrip recall is narrow in product scope but serious in consequence, and the practical safeguards, checking the patient ID on screen and enabling the validation settings, are what hospitals can apply while waiting for the November update. See also Continuous Glucose Monitoring for Type 2 Diabetes: Promising. More in our medical device coverage, and general regulator information is on the FDA medical devices pages.
What to watch next on the Nova Biomedical StatStrip recall
- The phased software rollout planned from November 2026.
- Any update to the FDA listing, including counts of reports.
- Hospital notices on how they are managing Gen 2.0 meters.
Frequently asked questions
Which meters are affected?
StatStrip Gen 2.0, Model 63685 and the Multipack Model 66739. The earlier Gen 1.86 is not included.
Is the glucose reading itself wrong?
Nova says analytical accuracy is not affected. The risk is that the result is assigned to the wrong patient or quality-control record.
Is this a brand-new recall?
No. Nova’s first letter went out on 31 July and was updated on 5 October; the FDA listed it on 20 October.
How we reported this: we relied on the FDA’s recall notice, current as of 20 October 2026. General background is labelled. Last updated: 20 October 2026. This article is news reporting and not medical or regulatory advice.