Z-0395-2016Class II

The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module...

Name: Z-0395-2016 The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module...
Creator: Powers Medical Devices, LLC
Published: 2015-10-01
License: https://open.fda.gov/license/

Powers Medical Devices, LLC / initiated 2015-10-01 / Open, Classified / root cause: labeling and UDI

FDA source

Powers Medical Devices, LLC began a recall of 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... on 2015-10-01. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0395-2016
Classification: Class II
Status: Open, Classified
Initiated: 2015-10-01
Posted: 2015-12-08
Recalling firm: Powers Medical Devices, LLC
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.
Product code: HCC Device, Biofeedback
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).
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: Powers Medical Devices, LLC intends to notify customers via certified U.S. Mail and supply the updated Instruction Manual via U.S. Mail or other tracked service. Instructions to customers include: 1) destroy the previous Instruction Manual, and replace it with the new one provided, 2) attach the new product label over the existing labeling without covering up the Model # and serial # of the device, 3) certify the destruction and replacement of the Instruction Manual nd replacement of the product label to the company using the form and self-addressed stamped envelopw provided.
Quantity in commerce: Total of 128 units
Distribution: Nationwide Distribution.
Product codes and lots: 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 12/2013; Serial Numbers A1075, A1076, A1077, A1078, A1079, A1080, A1081, A1082, A1083, A1070, A1072, A1073, A1084, A1086, A1087, A1088, A1089, A1090, A1085 (Ship Date 11/2013); Serial Numbers A1022, A1044 (Ship Date 10/2013); Serial Number A1059 (Ship Date 09/2013); Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013); Serial Numbers A1037, A1005, A1015, A1024, A1230, A1050, A1051, A1052, A1053, A1054, A1055, A1058, A1016, A1019, A1064, A1249 (Ship Date 07/2013); Serial Numbers A1006, A1020, A1004, A1023, A1021 (Ship Date 05/2013); Serial Numbers A1025, A1046, A1032 (Ship Date 04/2013); Serial Numbers A1038, A1049, A1029, A1026, A1035, A1039, A1036, A1031, A1030, A1028, A1027, A1034 (Ship Date 03/2013); Serial Number P11 (Ship Date 02/2013); Serial Number P-7 (Ship Date 11/2012); Serial Numbers A1013, P-8 (Ship Date 09/2012); Serial Numbers A1043, P-6, A1041, P-9 (Ship Date 07/2012);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0395-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0395-2016	Class II	Ongoing	Voluntary: Firm initiated	2015-12-16	2015-12-08

Product code HCC

K151050Class IIPacifier Activated Lullaby (PAL®)Power Medical Devices, LLC / cleared 2015-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)