Nova Biomedical Corporation: Medical Device Recall in 2025 - (Recall #: Z-0681-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

Product Classification:

Class I

Date Initiated: November 20, 2024

Date Posted: January 1, 2025

Recall Number: Z-0681-2025

Event ID: 95783

Reason for Recall:

A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.

Status: Ongoing

Product Quantity: 2,365 units

Code Information:

Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44

Distribution Pattern:

Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated