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Lumin

3b Medical, Inc. · Model LM3000 · UDI-DI 00860006339906

LRJ

510(k) clearances

1,867

Adverse events (4 deaths)

Recalls

377

Facilities

Description

Lumin serves as both a general-purpose sanitizing device for personal care items (e.g. cell phone, eyeglasses, keys, etc.) as well as CPAP accessories (e.g. hose, mask, and water chamber. In terms of CPAP sanitizer, there is no requirement for sterility or disinfection for single-patient re-use of CPAP accessories in the home. Most manufacturer instructions require simple cleaning with soap and water. Lumin is intended to be used as an adjunct to following the manufacturer’s instructions for routine cleaning but provides the convenience of bioburden reduction in 5 minutes. Lumin is designed to be used only with the CPAP accessories (i.e. CPAP Mask, hose, and water chamber), and not on the CPAP machine itself.

Recalls

Date	Firm	Reason
2026-06-30	Medline Industries, LP	Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2026-06-30	Medline Industries, LP	Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2026-06-30	Medline Industries, LP	Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2026-06-30	Medline Industries, LP	Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2023-12-20	MEDLINE INDUSTRIES, LP - Northfield	There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
2022-06-29	MEDLINE INDUSTRIES, LP - Northfield	stability failure
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-12-29	MEDLINE INDUSTRIES, LP - Northfield	Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.