CONTOURRecalls & reported problems across all models

We found 9 models of CONTOUR by Ascensia Diabetes Care US Inc. in the FDA's device registry (GUDID). Together they are named in 156 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2017 and Nov 21, 2025 — classified as 29 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (52 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CONTOUR problems

CONTOUR models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CONTOUR® 7080G

  Glucose Dehydrogenase, Glucose
  61 reports
• CONTOUR® 7151H

  Glucose Dehydrogenase, Glucose
  37 reports
• CONTOUR® 9545C

  Glucose Dehydrogenase, Glucose
  21 reports
• CONTOUR® 7097C

  Glucose Dehydrogenase, Glucose
  15 reports
• CONTOUR® 9556C

  Glucose Dehydrogenase, Glucose
  10 reports
• CONTOUR® 7189

  Glucose Dehydrogenase, Glucose
  6 reports
• CONTOUR® 7098C

  Glucose Dehydrogenase, Glucose
  3 reports
• CONTOUR® 7109B

  System, Test, Blood Glucose, Over The Counter
  2 reports
• CONTOUR® 7099C

  Glucose Dehydrogenase, Glucose
  1 report

Recent CONTOUR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Nonstandard Device; Nonstandard Device

  A CUSTOMER REPORTED THAT SHE PURCHASED THE CONTOUR® METER FROM THEIR LOCAL PHARMACY IN THE US, WHICH WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619657 ↗
• MalfunctionMay 1, 2025Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT SHE OPENED A BOX OF THE CONTOUR® TEST STRIPS AND THE BOTTLE WAS ALREADY OPEN. 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 21942048 ↗
• MalfunctionMar 24, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE ASCENSIA METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® 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 21677303 ↗
• MalfunctionSep 10, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HER CONTOUR METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT AFTER THE CUSTOMER REPLACED THE METER'S BATTERY, THE 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 20178249 ↗
• MalfunctionFeb 1, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR 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 18622491 ↗
• MalfunctionJan 9, 2024Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT HE PURCHASED A CONTOUR METER FROM CANADA AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. 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 18475578 ↗
• MalfunctionAug 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN A BLOOD GLUCOSE TEST WITH THE CONTOUR METER AND OBTAINED A READING OF 61 MG/DL AT 7:48 A.M. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. 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 17460188 ↗
• MalfunctionAug 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN A BLOOD GLUCOSE TEST WITH THE CONTOUR METER AND OBTAINED A READING OF 130 MG/DL AT 1:21 P.M. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. 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 17460186 ↗
• 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 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 16663597 ↗
• MalfunctionJan 4, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAD 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 16094368 ↗
• MalfunctionAug 1, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 357 MG/DL AT 9:27 A.M. AND 83 MG/DL AT 9:29 A.M. WITH THE CONTOUR 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 15138968 ↗
• MalfunctionMay 24, 2022Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAD 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 14489628 ↗
• MalfunctionOct 1, 2021Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED TO REPORT THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR 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 12561794 ↗
• MalfunctionJul 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING PROPERLY STORED IN THE MEMORY OF THE CONTOUR METER. FOR EXAMPLE, THE CUSTOMER OBTAINED A READING OF 100 MG/DL, WHICH WAS INCORRECTLY STORED. IN ANOTHER INSTANCE, A READING OF 100 MG/DL WAS STORED AS 86 MG/DL. 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 12098743 ↗
• MalfunctionJun 1, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR 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 11913702 ↗

Other Ascensia Diabetes Care US Inc. products

• CONTOUR NEXT13 models · 971 reports
• CONTOUR NEXT EZ3 models · 206 reports
• CONTOUR NEXT ONE6 models · 184 reports
• CONTOUR NEXT GEN5 models · 85 reports · 1 recall
• CONTOUR NEXT LINK 2.42 models · 87 reports
• CONTOUR NEXT LINK4 models · 45 reports