October 20, 2026 — SNN Newsroom. The U.S. Food and Drug Administration has identified a recall of certain Nova Biomedical StatStrip Glucose Hospital Meter Systems as its most serious type, warning that results could be assigned to the wrong patient’s medical record.
The affected meters are the StatStrip Glucose Hospital Meter System Gen 2.0, model 63685, and Glucose Hospital Meter System Multipack, model 66739. The FDA says the removal does not apply to earlier devices such as Gen 1.86.
According to the FDA, scanning a patient identification or quality-control barcode can leave earlier identifying information on the screen. If the incorrect identity is accepted, an otherwise accurate glucose measurement may be placed in another patient’s record. The agency says this could contribute to delayed treatment, unnecessary treatment including inappropriate insulin administration, or failure to treat the intended patient.
The FDA says Nova Biomedical sent affected customers an initial notification July 31 and revised its notice October 5. Customers were advised to remove affected meters where alternative devices are available; the FDA also lists temporary validation and identification checks for facilities without an alternative. A phased software update is expected in November 2026. The recall is a device-specific hospital safety issue, not a recall of all glucose meters.
As of October 5, the company had reported one serious injury and no deaths associated with the issue, according to the FDA. The FDA says the underlying glucose measurement performance is not affected.
Hospital personnel and other affected customers should follow the full FDA recall notice and device-specific instructions. For assistance, Nova Biomedical lists 1-800-545-6682. The FDA also provides its MedWatch reporting program for reporting device problems.
Source: U.S. Food and Drug Administration, October 20, 2026. This article does not offer individualized medical instructions.
