FDA Recalls Bright Embrace Bili Light Due to Incorrect Temperature Labeling
Physician Engineered Products, Inc. is recalling 97 Bright Embrace Single Bili Lights because the upper limit for ambient temperature was printed incorrectly in the instructions.
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, which typically corresponds to a moderate severity score when the hazard involves a labeling error rather than a direct physical defect causing injury.
Plain-English summary
Physician Engineered Products, Inc. is recalling 97 units of the Bright Embrace Single Bili Light, Model SBL60, used for newborn phototherapy. The recall was initiated because the upper limit for the ambient temperature for use of the device was printed incorrectly in the instructions.
The affected units were distributed worldwide, including in the United States to the states of California, Colorado, Florida, Kentucky, Massachusetts, Maryland, New Mexico, Pennsylvania, Tennessee, Texas, and Virginia, as well as to Egypt, Honduras, Saudi Arabia, and Singapore. Specific serial numbers for the recalled units are listed in the agency's official records.
Healthcare facilities and consumers should stop using the affected devices and contact Physician Engineered Products, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
- Manufacturer
- Physician Engineered Products, Inc.
- Category
- Medical Device — Phototherapy
- Hazard
- Affected units
- 97
Distribution
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