Severity
Moderate
ModerateClass IIOngoing
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 FDA Devices action (record #Z-2211-2023) was formally reported on July 26, 2023, with the manufacturer initiating the action on May 19, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ascensia Diabetes Care US, Inc. is listed as the recalling firm, operating out of Valhalla, NY. Federal records list the affected scope as 2,888 units.
The documented reason for this recall is: 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 pac… Distribution data in the federal record shows the product reached: Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
2,888 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
Contour¿ next GEN Blood Glucose Monitoring System. Recalled by Ascensia Diabetes Care US, Inc.. Units affected: 2,888 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2211-2023.
Where was the recalled product distributed? ▼
Distribution: Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2211-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 26, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.