FDA Devices recall · Reported November 28, 2012
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protect
The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to spe…
Kerr Corporation recalled The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. … - a moderate-severity action.
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. … was recalled by Kerr Corporation in November 28, 2012. Reason: The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser …. Check the official notice for the remedy. Verify recall #Z-0414-2013 with the FDA Devices before acting.
The recall
Kerr Corporation issued this moderate-severity FDA Devices recall-The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser ….
- Moderate
- severity level
- 639 units
- affected scope
- Class II
- classification
- November 28, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0414-2013 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
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.
Reason for recall
The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0414-2013 |
| Date reported | November 28, 2012 |
| Date initiated | April 10, 2012 |
| Recalling firm | Kerr Corporation |
| Firm location | Middleton, WI |
| Affected scope | 639 units |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Canada and EU. |
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-0414-2013) 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