Insight Instruments Recalls MLS Torpedo Mini-Light Ophthalmic Illuminator
Insight Instruments is recalling MLS Torpedo Mini-Light Ophthalmic illuminators because the product was registered as a Class I device but is actually a Class II device requiring FDA clearance.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (lack of required clearance) rather than a direct physical safety defect with reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Insight Instruments, Inc. is recalling the MLS Torpedo Mini-Light Ophthalmic single-port illumination device. This sutureless 25-gauge illuminator is intended for vitreo-retinal surgery when full field illumination of bimanual surgery is desired.
The recall is being conducted because the product was originally registered and distributed as a Class I medical device. It was subsequently determined to be a Class II medical device, which requires FDA market clearance. The agency classification for this recall is Class II.
The recall affects 10,212 units distributed worldwide, including nationwide in the United States (specifically AZ, CA, FL, IN, MA, MD, TX, and WA) and internationally to the Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey. Affected lots include part numbers 11007 and 11017 with various lot numbers and expiration dates ranging from April 2013 to May 2014. Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for instructions.
The recalled product
- Product
- MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
- Manufacturer
- Insight Instruments, Inc.
- Affected units
- 10,212
Distribution
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