CONTOUR® NEXT EZ 9628Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00301939628014), received between Apr 16, 2018 and Dec 15, 2025 — classified as 9 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (115 reports).

1 other recall cover devices cleared under the same FDA submission (K111268, K130265, K162336, K191286); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT EZ METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. THE CUSTOMER HAD RECENTLY REPLACED THE METER'S BATTERY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804184 ↗
• MalfunctionAug 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 273 MG/DL AND 34 MG/DL WITHIN 5 MINUTES WITH THE CONTOUR® NEXT EZ METER. THE CUSTOMER HAD TWO METERS, BUT DID NOT INDICATE IF THE READINGS WERE OBTAINED ON THE SAME METER OR DIFFERENT CONTOUR NEXT EZ METERS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAD ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KITS WERE SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864944 ↗
• MalfunctionJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING CORRECTLY STORED IN THE MEMORY OF THE CONTOUR® NEXT EZ METER. THE CUSTOMER STATED THAT THE VALUES DISPLAYED IN THE METER'S MEMORY DID NOT CORRESPOND TO THEIR OWN TEST RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292778 ↗
• MalfunctionJun 9, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT EZ METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168963 ↗
• MalfunctionJan 14, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146570 ↗
• MalfunctionJan 2, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT EZ METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057258 ↗
• MalfunctionNov 8, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640038 ↗
• MalfunctionNov 8, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT AFTER SHE CHANGED THE METER BATTERY, HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640032 ↗
• MalfunctionOct 15, 2024Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ASCENSIA CUSTOMER SERVICE ON BEHALF OF THE CUSTOMER TO SEEK ASSISTANCE WITH THEIR CONTOUR NEXT EZ METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE DECLINED TO SEND THE DEVICE FOR EVALUATION OR RECEIVE THE OFFERED REPLACEMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454140 ↗
• MalfunctionAug 14, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HER CONTOUR NEXT EZ METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981321 ↗
• MalfunctionJul 23, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806195 ↗
• InjuryMay 20, 2024No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT HE WAS ATTEMPTING TO PERFORM A CONTROL TEST WITH THE CONTOUR NEXT EZ METER AND OBTAINED AN E3 ERROR MESSAGE, WHICH IS INDICATIVE OF "USED STRIP INSERTED". THE CUSTOMER FELT SYMPTOMS OF HYPOGLYCEMIA, HOWEVER, AS HE WAS UNABLE TO VERIFY THE METER PERFORMANCE, HE COULD NOT PERFORM BLOOD GLUCOSE TESTING. THE CUSTOMER WENT TO CONSUME SUGAR, HOWEVER ON HIS WAY TO KITCHEN, HE FELL AND BROKE HIS ANKLE. LATER, THE CUSTOMER TOOK A CUP AND A HALF OF GRANULATED SUGAR. NO FURTHER TREATMENT DETAILS WERE PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Bone Fracture(s); Hypoglycemia

  MAUDE report 19351450 ↗
• MalfunctionApr 9, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO RECEIVE ASSISTANCE WITH HER CONTOUR NEXT EZ METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19073072 ↗
• MalfunctionApr 2, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026151 ↗
• MalfunctionFeb 6, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650166 ↗
• MalfunctionJan 3, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436153 ↗
• MalfunctionJan 2, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425920 ↗
• MalfunctionNov 15, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140041 ↗
• MalfunctionOct 27, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022244 ↗
• MalfunctionJun 9, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097164 ↗
• MalfunctionApr 13, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735684 ↗
• MalfunctionApr 3, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663588 ↗
• MalfunctionFeb 21, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409306 ↗
• MalfunctionFeb 13, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363482 ↗
• MalfunctionJan 4, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094373 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111268, K130265, K162336, K191286. One submission often covers many models, so check the product and lot details in each record.

• Z-2482-2015 · Jun 22, 2015 · Terminated
  Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary