CLASS II ONGOING Device recall · Reported 16 Dec 2015 · FDA Enforcement Report
The "Pacifier Activated Lullaby" recalled by Powers Medical Devices
Powers Medical Devices is recalling The "Pacifier Activated Lullaby" (PAL) System composed of three major components: the PAL, distributed nationwide in the US. The recall was initiated on 1 Oct 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0395-2016
- FDA event ID
- 72436
- Recalling firm
- Powers Medical Devices, Delray Beach, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Oct 2015
- FDA classified
- 8 Dec 2015
- Reported
- 16 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Oct 2015 | Recall initiated by company | |
| 8 Dec 2015 | Classified by FDA | +68 days |
| 16 Dec 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is The "Pacifier Activated Lullaby" (PAL) System composed of three major components: the PAL recalled?
Yes. Powers Medical Devices recalled The "Pacifier Activated Lullaby" (PAL) System composed of three major components: the PAL on 1 Oct 2015. The recall is Class II and its status is Ongoing. Recall number Z-0395-2016.
Why was it recalled?
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).
Which lots are affected?
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);
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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