Beevers Recalls Luma Wrap Phototherapy Swaddlers for Regulatory Misclassification
Beevers Manufacturing is recalling Luma Wrap neonatal phototherapy swaddlers because they were marketed without a required FDA 510(k) clearance.
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, but the source text identifies the cause as a regulatory misclassification and lack of 510(k) clearance rather than a physical defect or reported injury. This aligns with the rubric for moderate severity involving documentation or regulatory issues without reported harm.
Plain-English summary
Beevers Manufacturing & Supply, Inc. is recalling Luma Wrap neonatal phototherapy swaddlers. The product is designed to provide centered and comfortable boundaries for restive babies in the Neonatal Intensive Care Unit. The recall involves 240 total units across four specific lots: 112 units of lot 66812, 92 units of lot 66813, 17 units of lot 30660, and 19 units of lot 67879. The affected models include LW102 (medium), LW103 (large), and LW105 (extra large).
The recall was initiated because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA. This regulatory oversight means the device was distributed without the required premarket notification clearance.
The product was distributed to the United States, Germany, Austria, France, Italy, Spain, and Australia. Consumers and healthcare facilities should stop using the affected units and contact Beevers Manufacturing & Supply, Inc. for further instructions on the recall.
The recalled product
- Product
- Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
- Manufacturer
- Beevers Manufacturing & Supply, Inc.
- Category
- Medical Device — Neonatal Care
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 (5)
- Recalled units include: LW102 (medium)
- Lot 66812
- LW103 (large)
- Lots 66813 and 30660
- and LW105 (extra large)
Distribution
Distribution scope not specified by the agency.
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