Luma Wrap Phototherapy Swaddler is designed to provide centered and… — Class II medical device recall Z-2181-2014
Terminated recall by Beevers Manufacturing & Supply, Inc., reported 2014-08-20. Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product
| Recall number | Z-2181-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beevers Manufacturing & Supply, Inc., McMinnville, OR, United States |
| Recall initiated | 2014-07-11 |
| Classified | 2014-08-10 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2015-07-17 |
| Countries outside the US | AT, AU, DE, ES, FR, IT |
| Reason classes | unapproved product |
| Lot numbers | 30660, 66812, 66813, 67879, LW103, LW105 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2181-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.