Browse Device Recalls
19 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 19 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 19 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 20, 2024 | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. ... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescri... | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of errone... | Class I | Nova Biomedical Corporation |
| Sep 18, 2023 | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blo... | Potential risk of reporting erroneous creatinine patient results associated with the initial star... | Class II | Nova Biomedical Corporation |
| Sep 18, 2023 | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain ga... | Potential risk of reporting erroneous creatinine patient results associated with the initial star... | Class II | Nova Biomedical Corporation |
| Jun 19, 2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profil... | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the... | Class II | Nova Biomedical Corporation |
| Oct 10, 2013 | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactat... | Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell le... | Class II | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Prod... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Produ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These s... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Nu... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Produc... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Feb 25, 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 ... | Glucose test strips reports no result message when tested | Class II | Nova Biomedical Corporation |
| Feb 25, 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | Glucose test strips reports no result message when tested | Class II | Nova Biomedical Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.