CONTOUR NEXT EZRecalls & reported problems across all models
Ascensia Diabetes Care US Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 206
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 3 models of CONTOUR NEXT EZ by Ascensia Diabetes Care US Inc. in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2017 and Dec 15, 2025 — classified as 13 injuries, 193 malfunctions.
The most frequently reported specific device problem is “Missing Test Results” (166 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
Reports received per month, all models
Most reported CONTOUR NEXT EZ problems
Device problems
- Missing Test Results166
- Incorrect, Inadequate or Imprecise Result or Readings17
- High Readings14
- Nonstandard Device4
- No Device Output2
- Image Display Error/Artifact1
- Incorrect Measurement1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions111
- No Known Impact Or Consequence To Patient81
- Dizziness5
- Hypoglycemia3
- Insufficient Information3
- Shaking/Tremors3
- Weakness2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
CONTOUR NEXT EZ models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONTOUR® NEXT EZ 9628Glucose Dehydrogenase, Glucose145 reports
- CONTOUR® NEXT EZ 7252Glucose Dehydrogenase, Glucose49 reports
- CONTOUR® NEXT EZ 7553Glucose Dehydrogenase, Glucose12 reports
Recent CONTOUR NEXT EZ adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Ascensia Diabetes Care US Inc. products
All Ascensia Diabetes Care US Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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