FDA Devices recall · Reported July 26, 2023
Contour¿ next GEN Blood Glucose Monitoring System
Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters d…
Ascensia Diabetes Care US, Inc. recalled Contour¿ next GEN Blood Glucose Monitoring System - a moderate-severity action.
Contour¿ next GEN Blood Glucose Monitoring System was recalled by Ascensia Diabetes Care US, Inc. in July 26, 2023. Reason: Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM0…. Check the official notice for the remedy. Verify recall #Z-2211-2023 with the FDA Devices before acting.
The recall
Ascensia Diabetes Care US, Inc. issued this moderate-severity FDA Devices recall-Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM0….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- July 26, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2211-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Contour¿ next GEN Blood Glucose Monitoring System
Reason for recall
Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2211-2023 |
| Date reported | July 26, 2023 |
| Date initiated | May 19, 2023 |
| Recalling firm | Ascensia Diabetes Care US, Inc. |
| Firm location | Valhalla, NY |
| Affected scope | 2,888 units |
| Distribution | Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2211-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026