Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Luma Wrap Phototherapy Swaddler is designed to provide centered and Recalled by Beevers Manufacturing & Supply, Inc. Due to Beevers Manufacturing & Supply Inc. is recalling Luma...

Date: July 11, 2014
Company: Beevers Manufacturing & Supply, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beevers Manufacturing & Supply, Inc. directly.

Affected Products

Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.

Quantity: 240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).

Why Was This Recalled?

Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.

Where Was This Sold?

Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.

About Beevers Manufacturing & Supply, Inc.

Beevers Manufacturing & Supply, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report