Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 23, 2023
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Se…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott Diabetes Care, Inc. recalled FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System - a moderate-severity action.
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System was recalled by Abbott Diabetes Care, Inc. in August 23, 2023. Reason: If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for t…. Check the official notice for the remedy. Verify recall #Z-2414-2023 with the FDA Devices before acting.
The recall
Abbott Diabetes Care, Inc. issued this moderate-severity FDA Devices recall-If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for t….
- Moderate
- severity level
- 1.7M units
- affected scope
- Class II
- classification
- August 23, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2414-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2414-2023) was formally reported on August 23, 2023, with the manufacturer initiating the action on July 12, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Diabetes Care, Inc. is listed as the recalling firm, operating out of Alameda, CA. Federal records list the affected scope as 1,722,645, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the p… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, 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
1,722,645
Related Recalls
6
3 from same agency
Product description
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Reason for recall
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2414-2023 |
| Date reported | August 23, 2023 |
| Date initiated | July 12, 2023 |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Firm location | Alameda, CA |
| Affected scope | 1,722,645 |
| Distribution | US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, 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-2414-2023) 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? ▼
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System. Recalled by Abbott Diabetes Care, Inc.. Units affected: 1,722,645.
Why was this product recalled? ▼
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 23, 2023. Severity: Moderate. Recall number: Z-2414-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2414-2023) 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.
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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 August 23, 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.