CONTOUR® NEXT EZ 7553Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00301937553011), received between Oct 18, 2022 and Aug 27, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K111268, K130265, K162336); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 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. THE CUSTOMER MENTIONED THAT SHE HAD RESET THE METER'S TIME AND DATE. 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 22906772 ↗
• InjuryMar 20, 2025Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 300 MG/DL WITH THE CONTOUR® NEXT EZ METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA. NO SPECIFIC SYMPTOMS WERE PROVIDED. THE CUSTOMER CALLED AN AMBULANCE AND ANOTHER TEST WAS PERFORMED WITH THE PARAMEDICS' METER AND OBTAINED A READING OF 546 MG/DL. THE CUSTOMER WAS TAKEN TO THE HOSPITAL. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21652981 ↗
• MalfunctionMar 20, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE 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 21652980 ↗
• MalfunctionSep 4, 2024Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER'S 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 ADVOCATE 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 20135467 ↗
• MalfunctionSep 4, 2024High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT EZ METER AND OBTAINED READINGS OF 402 MG/DL AT 1:29 P.M. AND 109 MG/DL AT 1:37 P.M. A REPEAT TESTING WAS PERFORMED WITH A NON-ASCENSIA METER AND A READING OF 141 MG/DL WAS OBTAINED AT 1:37 P.M. 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. 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 20135466 ↗
• MalfunctionMar 12, 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 18883529 ↗
• MalfunctionMar 1, 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 18814856 ↗
• MalfunctionMar 1, 2024Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT ONE OF THEIR BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE 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 18813790 ↗
• MalfunctionOct 27, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED TO GET ASSISTANCE WITH HER CONTOUR NEXT EZ METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE 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 18022238 ↗
• MalfunctionJul 18, 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 17341776 ↗
• MalfunctionMar 20, 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 16576964 ↗
• MalfunctionOct 18, 2022Missing 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 15625960 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111268, K130265, K162336. 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