Kerr Laser Loupes Recalled Due to Wipeable Laser Frequency Markings
Kerr Corporation is recalling 639 Laser Loupes because the ink marking the laser frequency protection may wipe off, though the devices function correctly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall involving a labeling/adhesion issue where the device functions correctly but the safety marking may be lost, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Kerr Corporation is recalling 639 units of Laser Loupes, a dental loupe with laser eye protection. The recall was initiated because the ink used to mark which laser frequency each loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device.
The affected units were produced and distributed since September 2008. Distribution was worldwide, including the United States (nationwide), Canada, and the European Union. The Laser Loupes are custom made-to-order products with no general model, catalog, code, lot, or serial numbers, and they have no expiration date.
Consumers should check their Laser Loupes to ensure the laser frequency markings are legible. If the markings have wiped off, the device may not provide the intended laser eye protection for the specific frequency being used.
The recalled product
- 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…
- Manufacturer
- Kerr Corporation
- Affected units
- 639
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- catalog
- code
Distribution
Distributed nationwide across the United States.
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