The "Pacifier Activated Lullaby" — Class II medical device recall Z-0395-2016
Ongoing recall by Powers Medical Devices, LLC, reported 2015-12-16, distributed nationwide. PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consist
| Recall number | Z-0395-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Powers Medical Devices, LLC, Delray Beach, FL, United States |
| Recall initiated | 2015-10-01 |
| Classified | 2015-12-08 |
| Reported by FDA | 2015-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 128 units |
| Reason classes | labeling |
| Serial numbers | A1004, A1005, A1006, A1013, A1015, A1016, A1019, A1020, A1021, A1022, A1023, A1024, A1025, A1026, A1027, A1028, A1029, A1030, A1031, A1032, A1034, A1035, A1036, A1037, A1038 and 98 more |
Product
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
Reason for recall
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
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-0395-2016. 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.