Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0414-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on April 10, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Kerr Corporation is listed as the recalling firm, operating out of Middleton, WI. Federal records list the affected scope as 639 units.
The documented reason for this recall is: 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 perm… Distribution data in the federal record shows the product reached: Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.. 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
639 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Kerr Corporation. Units affected: 639 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0414-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Canada and EU..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0414-2013) 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 November 28, 2012. 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.