Z-1245-2009

Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part #...

Name: Z-1245-2009 Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part #...
Creator: Sybaritic, Inc
Published: 2007-05-15
License: https://open.fda.gov/license/

Sybaritic, Inc. / initiated 2007-05-15 / Terminated / root cause: design

FDA source

Sybaritic, Inc began a recall of Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D), Sybaritic, Inc., 9229 James Avenue South... on 2007-05-15. The reason FDA records is "Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1245-2009
Status: Terminated
Initiated: 2007-05-15
Posted: 2009-07-15
Terminated: 2012-07-05
Recalling firm: Sybaritic, Inc.
Product: Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D), Sybaritic, Inc., 9229 James Avenue South, Minneapolis, MN 55431.
Product code: IMB Cabinet, Moist Steam
Reason for recall: Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs over the side wall of the unit directly onto the steam ports and cause burns. There were 18 injuries and 8 malfunctions reported.
Root cause tag: design
FDA root cause: Device Design
Action: Sybaritic, Inc. issued a letter dated May 15, 2007 addressed to "Hydration Station Customer". The letter informed the customer of the new 2007 Hydration Station Upgrade Improvement Kits including instructions and advised the customer to coordinate the installation of the components with their Technical Service Department. Further questions can be addressed to Sybaritic, Inc. Technical Administration at 1-800-445-8418 extension 373.
Quantity in commerce: 370
Distribution: Worldwide Distribution - US including states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV and WI and CANADA.
Product codes and lots: Serial Numbers: 206045779, SG2061042159, 206054856, 206054874, 205024943, 206055838, 206065900, 205086311, 205104399, 205044085, 205104389, SG2061052196, SG2061242331, 205026973, 205105418, 205124542, 205085303, 206045774, SG2061042139, 206025737, SG2061252335, SG2061042144, 205036004, 206054864, 206074978, SG2070142422, 206044815, 205114444, 206045777, 205106415, 205116435, 206064932, SG2070452617, 205026946, 205105397, 205044117, SG2070352558, 206055846, 205104413, 205114480, 205104402, 206034734, 206064954, 206045775, 206055872, 206065917, 2060742003, 205024996, 206024711, 206055879, 206064931, SG2070442571, SG2061242336, SG2061052167, SG2061252330, SG2061042152, 205016864, SG2070142362, 205114443, 205105419, 206044772, 206054883, SG2061252351, 205125523, 2060942089, SG2061142232, 206064949, 206065910, 205124550, 205115440, 206045781, 205085300, SG2061152280, 2060952083, 206075982, 206045773, 206064902, SG2070152435, 205016909, 206044770, 205114464, 206044801, 206075002, SG2061252339, 206035735, 205114456, 206045778, 206055860, 2060942063, 206054889, 206044814, SG2061152278, 205126569, 206075986, SG2070142383, SG2061052140 206054842, 206034728, SG2061042175, 206054854, SG2061152250, SG2061152223, 205024974, 205014893, 206045771, 205096337, 205105400, 205025988, SG2061042164, 205026938, 205046086, 205025939, 206065964, 205025978, SG2061252345, 205104390, 206044799, SG2061252338, SG2070152353, 206055855, SG2070442574, SG2070352513, SG2070452616, SG2070452610, 206045807, 206064965, 205114494, 205105408, 205015910, 206044802, SG2061242332, SG2070342501, 206044782, SG2070452608, SG2070152378, 205116476, 205104405, 205116431, 206074983, 206064938, 205116503, 206034730, SG2061242346, 206045767, 206035723, SG2061252341, 206045776, 206065945, SG2061252329, 204115767, 206064903, 205106395, 205106398, SG2060952114, 205116506, SG2070352490, SG2061142235, 206035729, 205016896, 204126827, 206044786, 206044783, 206064913, 206044812, 205105407, SG2060952109, SG2070242441, SG2070242446, 206065953, SG2070152389, 206054888, 205014920, SG2070442573, 206044818, 206045800, SG2061252347, 206064962, 206054880, 206045822, 206064946, 205034036, 205115495, 205115495, 206055885, 206065950, SG2070152391, 206055890, 2060952076, 206045787, SG2061052213, 206044823, SG2061242327, 206065942, SG2061052160, SG2060942123, 205094380, 205114468, 206035733, 205025976, SG2070152386, 206065936, SG2070142392, SG2061242344, 20634755, SG2061042204, 206054861, 206065901, SG2070452576, SG2070152382, SG2070452572, 205126515, 205125558, SG2061042205, SG2070142356, 206074994, 206034742, 205124565, 206045813, 205104428, 206044809, 206045808, SG2070252447, 205126527, 205024977, SG2060952113, 205105422, 206055868, SG2070242472, 205115460, SG2070142385, SG2070142385, SG2060942125, 206054891, SG2061052202, 206045824, 205105392, 205024984, 206075995, 206034732, 205026981, SG2061042199, SG2060952118, 205044116, 205016898, 205106393, 206045798, 205044087, 205096350, SG2061052177, SG2060952124, SG2070152417, SG2070342556, SG2070452622, SG2061252343, 204095524, SG2070142373, SG2070152407, SG2070142354, 206045817, 206065951, 206065963, SG2061242334, 205024937, 206045819, 2060655873, SG2070152364, SG2061042169, SG2060942119, SG2060952120, SG2061142269, SG2060942108, SG2060942105, 206054865, SG2070242440, 205114484, 205016923, SG2070142396, SG2070152399, 205084307, 206034721, SG2061042151, SG2061042171, SG2061152283, SG2061052168, 204095422, 206054850, 206065909, 206035724, 206045810, 205035068, SG2070142433, 206045784, 204125834, SG2070542669, 206055884, 206044820, SG2070152393, SG2061052161, 206055886, SG2061052172, SG2070152432, 206065944, 206034750, 206055859, SG2070142371, 205015895, 205024972, SG2070252454, SG2070252469, SG2070342551, SG2070352492, SG2070352552, 204096525, 204116734, SG2061252349, SG2070142355, 205106862, SG2060952115, 206074979, 206035727, 205114436, SG2061052141, 206064943, SG2070142411, SG2061252340, SG2070142434, SG2070352553, 206055858, SG2061042197, SG2061242350, 205046089, 205115493, 205014863, 206044785, SG2070152399, SG2070142394, SG2070252467, SG2070242481, SG2070342557, 205036066, SG2070152366, 205014894, SG2061052166, 2060942082, SG2070152395, SG2070152358, 206045805, SG2070442634, SG2070252444, SG2061042155, SG2061052176, 205116432, 205116511, 206026670, 206054887, 206075998, SG2060942104, SG2070252471, 206036720, SG2060942084, 205045088, 205124576, SG2061242333, 204116738, SG2061052150, SG2061052203, 205036042, SG2070152378, SG2070242482 and SG2070242488.

Product code IMB

K003916Class IIDermalife Hydrofusion Skin & Body Care SystemScandia Manufacturing , Ltd. / cleared 2002-04-15

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)