The Recall Desk
ModerateFDA (Devices)·Z-0518-2013·Announced 2012-12-19

Quasar Bio-Tech Recalls Unapproved Infrared LED Lamps and Accessories

Quasar Bio-Tech is recalling the Quasar MD and other infrared LED devices because they are unapproved for marketing in the United States.

What this means for you

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific injuries, illnesses, or deaths, and the hazard is primarily regulatory (unapproved device) rather than a direct physical defect causing harm.

Plain-English summary

Quasar Bio-Tech, Inc. dba Silver Bay LLC is recalling the Quasar MD, Baby Quasar, Baby Quasar Pink, and Quasar Power Pack. The Quasar MD is an infrared LED lamp that emits energy in the near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. The device is intended to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and may temporarily increase local blood circulation.

The recall is being conducted because the devices are unapproved. The source text does not specify the exact regulatory basis for the unapproved status beyond the statement that the device is unapproved.

A total of 7,734 devices were distributed worldwide, including nationwide distribution in the United States and in several international countries. Consumers should stop using the recalled products and contact the manufacturer for further instructions.

The recalled product

Product
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emi
Manufacturer
Quasar Bio-Tech, Inc. dba Silver Bay LLC
Category
Medical Device — Infrared Therapy Device
Hazard
Affected units
7,734

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 (20)

  • Quasar MD- Model QMD-101 UPC Code 837654072196
  • Batch # 11652
  • 11727
  • 2441
  • 11870
  • 11884
  • 11955
  • 11969
  • 12005
  • 12006
  • 12029
  • 12057
  • 13008
  • 13193
  • 13199
  • 13221
  • 13242
  • 13271
  • 13288
  • 13325

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Quasar Bio-Tech, Inc. dba Silver Bay LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Quasar Bio-Tech, Inc. dba Silver Bay LLC

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Same hazard · unapproved device

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