Recall Register

Nova Biomedical Corporation: FDA recalls

FDA enforcement reports name Nova Biomedical Corporation as the recalling firm in 7 events. The events have 24 product records. The recalls started from 2013 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

7 events, newest first.

FDA enforcement events of Nova Biomedical Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
29 Jul 2026StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.DeviceClass I5Ongoing
20 Nov 2024StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.DeviceClass I3Ongoing
18 Sep 2023Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, RemanufacturedDeviceClass II2Ongoing
19 Jun 2017Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat…DeviceClass II1Terminated
10 Oct 2013Nova 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.DeviceClass II1Terminated
15 Jul 2013Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of…DeviceClass I10Terminated
25 Feb 2013Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214DeviceClass II2Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Nova Biomedical Corporation: events for each product type
TypeEvents
Device7
Nova Biomedical Corporation: events in each class
ClassEvents
Class II4
Class I3
Share of the events of the firm in Class I
43%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Nova Biomedical Corporation, by the year that the recall started. The largest year is 2013, with 3 events.

Official channels

Cite this page

Recall Register. Nova Biomedical Corporation: FDA recalls. https://recallregister.com/firm/nova-biomedical-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Nova Biomedical Corporation have?
Class II: 4 events. Class I: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Nova Biomedical Corporation?
FDA event 99546, which the firm started on 29 Jul 2026. The first product in the record is: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
How many FDA recalls of Nova Biomedical Corporation have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.