FDA Device recall Z-0414-2013
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection by Kerr, citing 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 spec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0414-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-10 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kerr |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | The Laser Loupes are custom made-to-order products. There are no general model, catalog, code, lot or serial number…The Laser Loupes are custom made-to-order products. There are no general model, catalog, code, lot or serial numbers. Laser Loupes have no expiration date. The affected units were produced and distributed since September 2008. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2013%22
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