Hyperion Medical Recalls HyperBlue 1530 Laser Brochures for Misleading Claims
Hyperion Medical is recalling brochures and website information for the HyperBlue 1530 laser because they promoted features not cleared by the FDA.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses documentation and labeling issues regarding uncleared features, which falls under the 'Low' severity criteria for documentation issues and packaging-only problems.
Plain-English summary
Hyperion Medical is recalling all brochures printed before November 20, 2013, and online information available before December 3, 2013, for the HyperBlue 1530 medical laser. The recall involves 3,346 printed brochures and the associated web content.
The recall was initiated because the brochures and website promoted features that had not been cleared in the product's premarket notification to the FDA. Specifically, the materials made claims that the laser could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination, and that the product could be used with a 15 mm hand piece.
The affected materials were distributed in the United States, including the states of Pennsylvania, Maryland, Utah, Texas, Ohio, Georgia, Missouri, Florida, Colorado, and Washington. Consumers and healthcare providers should stop using these specific brochures and verify product capabilities directly with the manufacturer or through updated FDA-cleared documentation.
The recalled product
- Product
- All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
- Manufacturer
- Hyperion Medical
- Category
- Medical Device — Laser Device
- Hazard
- Affected units
- 3,346
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)
- All brochures and online literature printed before November 20
- 2013.
Distribution
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereNephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims
FDA (Devices) · 2013-12-25
- SevereFDA Recalls Sureflex 910 Lithotripsy Fibers Due to Cleaning Validation Issues
FDA (Devices) · 2015-07-29
- ModerateFDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- HighSurgical and Cardiovascular Device Marketing Brochures Recalled for Documentation Errors
FDA (Devices) · 2024-04-24
- ModerateQuanta System Q-Plus T Laser Recall for Promotional Material Labeling
FDA (Devices) · 2013-01-23
- ModerateFDA Recalls Sure F!ex Laser Fibers Due to Cleaning Validation Issues
FDA (Devices) · 2015-07-29