RegWardenFDA facility compliance records
Recall

Class II — Nova Biomedical Corporation

Recalling firmNOVA BIOMEDICAL CORP.
Registered facilityView this company's 4 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonRevised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
ProductNova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
Quantityest. 200,000
DistributionNationwide Distribution.
Initiated2013-10-10
Classified2014-01-09
Terminated2014-03-24
Recall numberZ-0650-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Nova Biomedical Corporation (Z-0650-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66398/

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