StatStrip Glucose Meters
The StatStrip Glucose Hospital Meter System may show a previously scanned barcode.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Nova Biomedical Corporation, of Waltham, Massachusetts, is recalling certain StatStrip Glucose and B- Ketone meters and StatStrip Glucose Hospital Meter Systems.
A software synchronization/timing issue in the barcode scanning and patient data processing component causes the device to intermittently retain a previously scanned barcode, including patient identification (ID) barcodes and quality control (QC) solution ID barcodes, when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test.
The recall began on July 29, 2026, and was added to the FDA's Enforcement Report on September 11, 2026.
The products were distributed nationwide and in foreign countries including Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, and the United Kingdom.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match your product and all the details in one listed combination.
StatStrip Glucose Hospital Meter System.
- Model
- 63685
- UDI-DI
- 0038548063685
- Model
- 66739
- UDI-DI
- 00385480636858
StatStrip Glucose and B- Ketone meter.
- Model
- 63683
- UDI-DI
- 00385480664295
- Model
- 63910
- UDI-DI
- 00385480639101
- Model
- 66429
- UDI-DI
- 00385480636834
Details
- Company began the recall
- Sold in
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.
- Event ID
- 99546
- Recall numbers
- Z-3128-2026 to Z-3132-2026
- Company
- Nova Biomedical CorporationWaltham, Massachusetts
- Hazard
- Software defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
