Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported January 1, 2025
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
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 sys…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nova Biomedical Corporation recalled StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use bl… - a critical-severity action.
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use bl… was recalled by Nova Biomedical Corporation in January 1, 2025. Reason: A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose …. Check the official notice for the remedy. Verify recall #Z-0681-2025 with the FDA Devices before acting.
The recall
Nova Biomedical Corporation issued this critical-severity FDA Devices recall-A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose ….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- January 1, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0681-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0681-2025) was formally reported on January 1, 2025, with the manufacturer initiating the action on November 20, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Nova Biomedical Corporation is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 2,365 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,365 units
Related Recalls
6
3 from same agency
Product description
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0681-2025 |
| Date reported | January 1, 2025 |
| Date initiated | November 20, 2024 |
| Recalling firm | Nova Biomedical Corporation |
| Firm location | Waltham, MA |
| Affected scope | 2,365 units |
| Distribution | Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0681-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.. Recalled by Nova Biomedical Corporation. Units affected: 2,365 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Critical. Recall number: Z-0681-2025.
Where was the recalled product distributed? ▼
Distribution: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0681-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 1, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.