FDA Device recall Z-0395-2016
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pa…
- FDA Device
- Class II
- ongoing
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pa… by Powers Medical Devices, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0395-2016 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2015-10-01 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Powers Medical Devices |
| Distribution | US |
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
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).
Identifiers
| code_info | Serial Numbers A1221, A1226 (Ship Date 07/2015); Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015); Seri…Serial Numbers A1221, A1226 (Ship Date 07/2015); Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015); Serial Number A1246 (Ship Date 04/2015); Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015); Serial Number A1225 (Ship Date 01/2015); Serial Numbers A1241, A1242 (Ship Date 12/2014); Serial Number A1036 (Ship Date 11/2014); Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014); Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014); Serial Number A1227 (Ship Date 08/2014); Serial Number A1223 (Ship Date 07/2014); Serial Numbers A1218, A1220 (Ship Date 06/2014); Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014); Serial Numbers A1214, A1064 (Ship Date 03/2014); Serial Numbers A1087, A1213 (Ship Date 01/2014); Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0395-2016%22
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