FDA Devices recall · Reported August 5, 2015
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Acon Laboratories, Inc. recalled Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Pro… - a low-severity action.
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Pro… was recalled by Acon Laboratories, Inc. in August 5, 2015. Reason: Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.. Check the official notice for the remedy. Verify recall #Z-2322-2015 with the FDA Devices before acting.
The recall
Acon Laboratories, Inc. issued this low-severity FDA Devices recall-Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment..
- Low
- severity level
- Class III
- classification
- August 5, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2322-2015 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
Reason for recall
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2322-2015 |
| Date reported | August 5, 2015 |
| Date initiated | June 17, 2015 |
| Recalling firm | Acon Laboratories, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 1,283 kits |
| Distribution | U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA |
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-2322-2015) 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 (Low), 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