Bright Embrace — Class II medical device recall Z-2486-2015
Terminated recall by Physician Engineered Products, Inc., reported 2015-09-09, distributed in CA, CO, FL, KY, MA, MD, NM, PA…. Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
| Recall number | Z-2486-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physician Engineered Products, Inc., Fryeburg, ME, United States |
| Recall initiated | 2013-08-31 |
| Classified | 2015-08-31 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2015-09-02 |
| Distributed | CA, CO, FL, KY, MA, MD, NM, PA, TN, TX, VA |
| Countries outside the US | EG, HN, SA, SG |
| Quantity | 97 units |
| Serial numbers | 1002565, 1002579, 1002632, 1002644, 1002655, 1002688, 1002689, 1002736, 1002746, 1002753-1002762 |
| Model numbers | BL60 |
Product
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Reason for recall
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
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-2486-2015. 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.