FDA Medical Device Recalls (openFDA)
Sybaritic, Inc: Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D), Sybaritic, Inc., 9229 James Avenue South, Minneapolis, MN 55431.
- Recall number
- Z-1245-2009
- 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.
- Status
- Terminated
- Initiated
- 2007-05-15
- Posted
- 2009-07-15
- Terminated
- 2012-07-05
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K003916"]
- PMA numbers
- not on file
- Product code
- IMB
- Firm FEI
- 2131125
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28