UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN 05704916000264 and pending, Serial Numbers: 2008018, 2003427, 2008941, 2005905, 5014230, 2008447, 2005014, 2005669, 2006518, 5013628, 2007486, 2004009, 2004033, 2005897, 2004848, 2005428, 2005443, 2001579, 2002735, 5015492, 2008928, 2008949, 2002410, 2005561, 2004928, 2005883, 2005791, 2004802, 5016163, 2006012, 2003156, 2001915, 2004930, 2008654, 2004644, 2004812, 2007365, 2001350, 2008922, 2005945, 2003228, 2006454, 2005870, 2006185, 2007470, 2002654, 2003100, 2007539, 5014068, 5013784, 2003912, 5015223, 2001558, 2002650, 5011926, 5012262, 2001517, 2001354, 2008589, 2008411, 2006490, 2004572, 5010710, 2002822, 5015605, 5014242, 2003084, 5016412, 5012648, 2003324, 5009250, 5009251, 2002232, 2002346, 2005369, 5014235, 5016277, 2008650, 2008905, 2006432, 2004787, 2005721, 2006037, 2008891, 2006751, 2001448, 2003531, 2002506, 2007347, 2007488, 2004513, 5009252, 2006023, 5013588, 2005314, 2007509, 2002960, 2003433, 2005938, 2005931, 2004809, 2007533, 2002512, 2004174, 2001879, 2008807, 5014405, 2008964, 2007342, 5009257, 5010973, 5012165, 2008198, 2008915, 2008882, 2008879, 2008920, 2008855, 5011928, 2006822, 2008438, 2007599, 2007542, 2007541, 5013421, 2001451, 2006499, 5016440, 2008894, 2003924, 2003943, 2007536, 2001807, 2004573, 2003257, 2003105, 2004535, 2007576, 2002957, 2004274, 2007490, 2007511, 2001887, 5009680, 2003235, 5011032, 5012533, 2006684, 2007587, 2003230, 2001798, 5016220, 2006033, 2005263, 2005273, 2006671, 5011183, 2008617, 2008333, 5014244, 2006169, 2008439, 2005946, 2003078, 2006843, 5015688, 2006053, 5016042, 2006812, 5015047, 5015109, 2008296, 5013159, 2004184, 2005264, 2008190, 2004061, 5016286, 2004917, 2003533, 2009148, 2002511, 2003082, 2003986, 2008623, 2004062, 5010777, 2000120, 2001453, 2001456, 5013041, 5013042, 2004083, 2004528, 2002104, 5012515, 2001132, 2003077, 2006474, 2008661, 2006168, 2006180, 2006293, 2006303, 2006336, 2006354, 2000956, 2000957, 2003933, 2003936, 2003984, 2006138, 2006206, 2000963, 2007859, 2002406, 2002407, 2005366, 2004912, 2004943, 2005378, 2008391, 2008918, 2006360, 2004272, 2004294, 2004297, 2006459, 2007716, 2007860, 2002651, 2006292, 2005181, 2000952, 2004176, 5012022, 5015377, 2004926, 5016417, 5016425, 5016426, 2005371, 2007506, 2005499, 5016444, 2000798, 2004396, 5015489, 5011703, 5014069, 2002507, 2000960, 2002821, 2002963, 2007577, 5012076, 2007464, 2008414, 2002225, 2008335, 2008401, 5016027, 5011179, 2008692, 5012040, 5008892, 2008394, 2008420, 2008418, 2002959, 2001349, 5015362, 2004267, 2003527, 2007640, 2005881, 2000959, 2004598, 2008658, 2001450, 5011174, 2000879, 2004810, 2006068, 2007459, 2008817, 2005362, 2007489, 2001509, 5013150, 5013164, 5013231, 5015723, 2006728, 2006901, 2004182, 5015603, 5014120, 5016340, 2006425, 2001115, 2001118, 2001128, 5016245, 5016246, 2005431, 2006470, 5014065, 5009661, 2008408, 2004929, 2005963, 5008907, 2007457, 2004822, 5009495, 5009596, 2006003, 2002409, 2005930, 5013023, 5012164, 2006755, 2004672, 5012536, 2006734, 5007896, 5007893, 2001561, 2005739, 2005741, 2005746, 2003561, 2007456, 2002616, 2006396, 2002112, 2002242, 2002404, 2002508, 2002235, 2004691, 5012926, 2008019, 5016273, 5016274, 2008636, 2008014, 2004925, 5015229, 5016338, 2003934, 5011420, 2004063, 2005901, 5014119, 5010411, 5014313, 5012161, 2002739, 5012338, 2006415, 2005359, 2001514, 2007585, 2002230, 2006384, 2006438, 2003129, 2004803, 2004805, 5009592, 2007535, 2004641, 2007499, 5016441, 5012535, 5013783, 5016275, 2001455, 5014830, 5016439, 2007324, 2004032, 5014404, 5008183, 2004615, 2000954, 5015606, 2000666, 2000667, 2002742, 5013317, 2004514, 5012078, 5013613, 2002620, 2003096, 5009508, 5011329, 5011947, 5011224, 5011318, 5011162, 5011946, 5011187, 5016241, 2004657, 5013032, 5008140, 5008673, 5013850, 2001120, 2003234, 5016168, 5016169, 2004048, 5011726, 2005508, 5015406, 2001911, 5011317, 2001914, 2005542, 2003076, 5012446, 5012589, 2004016, 2004007, 5013422, 2000613, 2000796, 2004549, 2004825, 5011031, 2000612, 2000615, 2001345, 5016136, 2004001, 2002106, 2002110, 2006815, 2006435, 2006534, 5013229, 2000962, 2003265, 2008951, 2006680, 2008017, 2008269, 2008326, 2008397, 2008409, 5013379, 2009219, 2008952, 2001508, 5008056, 5016328, 2004169, 2005867, 5013249, 2001126, 5008054, 2007479, 2002402, 2002403, 5013629, 2001131, 2001288, 2001800, 2003080, 2003085, 2003099, 2003102, 2003128, 2003264, 2003272, 2005576, 5015102, 5015412, 5011702, 5015985, 2009228, 5011838, 5009718, 5008889, 2006030, 5014503, 2003888, 2002228, 5011320, 5012162, 5012166, 5014777, 2003978, 2004382, 2001291, 2000117, 2006556, 2003127, 5012928, 2004660, 2004804, 2006393, 2008416, 2008427, 2008614, 2004276, 2004392, 2006405, 2008429, 5014504, 5015981, 5013845, 5008676, 5007898, 5010752, 2007473, 5008908, 5015484, 5008677, 2005817, 2004015, 2005757, 2005911, 2005342, 2003945, 2003975, 2007467, 2003306, 2003922, 2006029, 2005830, 2003961, 2003131, 5013031, 2003885, 2003887, 2003886, 2001353, 2004008, 2004913, 2005993, 2003261, 2006891, 2005854, 2005750, 2004548, 2005353, 2002623, 2002656, 2002738, 2006805, 2003921, 2004041, 2005763, 2007812, 2008023, 2008025, 2008612, 2008863, 2008867, 2004927, 2006115.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
B-K Medical A/S
Reason for Recall:
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

Product Codes/Lot Numbers:

GTIN 05704916000264 and pending, Serial Numbers: 2008018, 2003427, 2008941, 2005905, 5014230, 2008447, 2005014, 2005669, 2006518, 5013628, 2007486, 2004009, 2004033, 2005897, 2004848, 2005428, 2005443, 2001579, 2002735, 5015492, 2008928, 2008949, 2002410, 2005561, 2004928, 2005883, 2005791, 2004802, 5016163, 2006012, 2003156, 2001915, 2004930, 2008654, 2004644, 2004812, 2007365, 2001350, 2008922, 2005945, 2003228, 2006454, 2005870, 2006185, 2007470, 2002654, 2003100, 2007539, 5014068, 5013784, 2003912, 5015223, 2001558, 2002650, 5011926, 5012262, 2001517, 2001354, 2008589, 2008411, 2006490, 2004572, 5010710, 2002822, 5015605, 5014242, 2003084, 5016412, 5012648, 2003324, 5009250, 5009251, 2002232, 2002346, 2005369, 5014235, 5016277, 2008650, 2008905, 2006432, 2004787, 2005721, 2006037, 2008891, 2006751, 2001448, 2003531, 2002506, 2007347, 2007488, 2004513, 5009252, 2006023, 5013588, 2005314, 2007509, 2002960, 2003433, 2005938, 2005931, 2004809, 2007533, 2002512, 2004174, 2001879, 2008807, 5014405, 2008964, 2007342, 5009257, 5010973, 5012165, 2008198, 2008915, 2008882, 2008879, 2008920, 2008855, 5011928, 2006822, 2008438, 2007599, 2007542, 2007541, 5013421, 2001451, 2006499, 5016440, 2008894, 2003924, 2003943, 2007536, 2001807, 2004573, 2003257, 2003105, 2004535, 2007576, 2002957, 2004274, 2007490, 2007511, 2001887, 5009680, 2003235, 5011032, 5012533, 2006684, 2007587, 2003230, 2001798, 5016220, 2006033, 2005263, 2005273, 2006671, 5011183, 2008617, 2008333, 5014244, 2006169, 2008439, 2005946, 2003078, 2006843, 5015688, 2006053, 5016042, 2006812, 5015047, 5015109, 2008296, 5013159, 2004184, 2005264, 2008190, 2004061, 5016286, 2004917, 2003533, 2009148, 2002511, 2003082, 2003986, 2008623, 2004062, 5010777, 2000120, 2001453, 2001456, 5013041, 5013042, 2004083, 2004528, 2002104, 5012515, 2001132, 2003077, 2006474, 2008661, 2006168, 2006180, 2006293, 2006303, 2006336, 2006354, 2000956, 2000957, 2003933, 2003936, 2003984, 2006138, 2006206, 2000963, 2007859, 2002406, 2002407, 2005366, 2004912, 2004943, 2005378, 2008391, 2008918, 2006360, 2004272, 2004294, 2004297, 2006459, 2007716, 2007860, 2002651, 2006292, 2005181, 2000952, 2004176, 5012022, 5015377, 2004926, 5016417, 5016425, 5016426, 2005371, 2007506, 2005499, 5016444, 2000798, 2004396, 5015489, 5011703, 5014069, 2002507, 2000960, 2002821, 2002963, 2007577, 5012076, 2007464, 2008414, 2002225, 2008335, 2008401, 5016027, 5011179, 2008692, 5012040, 5008892, 2008394, 2008420, 2008418, 2002959, 2001349, 5015362, 2004267, 2003527, 2007640, 2005881, 2000959, 2004598, 2008658, 2001450, 5011174, 2000879, 2004810, 2006068, 2007459, 2008817, 2005362, 2007489, 2001509, 5013150, 5013164, 5013231, 5015723, 2006728, 2006901, 2004182, 5015603, 5014120, 5016340, 2006425, 2001115, 2001118, 2001128, 5016245, 5016246, 2005431, 2006470, 5014065, 5009661, 2008408, 2004929, 2005963, 5008907, 2007457, 2004822, 5009495, 5009596, 2006003, 2002409, 2005930, 5013023, 5012164, 2006755, 2004672, 5012536, 2006734, 5007896, 5007893, 2001561, 2005739, 2005741, 2005746, 2003561, 2007456, 2002616, 2006396, 2002112, 2002242, 2002404, 2002508, 2002235, 2004691, 5012926, 2008019, 5016273, 5016274, 2008636, 2008014, 2004925, 5015229, 5016338, 2003934, 5011420, 2004063, 2005901, 5014119, 5010411, 5014313, 5012161, 2002739, 5012338, 2006415, 2005359, 2001514, 2007585, 2002230, 2006384, 2006438, 2003129, 2004803, 2004805, 5009592, 2007535, 2004641, 2007499, 5016441, 5012535, 5013783, 5016275, 2001455, 5014830, 5016439, 2007324, 2004032, 5014404, 5008183, 2004615, 2000954, 5015606, 2000666, 2000667, 2002742, 5013317, 2004514, 5012078, 5013613, 2002620, 2003096, 5009508, 5011329, 5011947, 5011224, 5011318, 5011162, 5011946, 5011187, 5016241, 2004657, 5013032, 5008140, 5008673, 5013850, 2001120, 2003234, 5016168, 5016169, 2004048, 5011726, 2005508, 5015406, 2001911, 5011317, 2001914, 2005542, 2003076, 5012446, 5012589, 2004016, 2004007, 5013422, 2000613, 2000796, 2004549, 2004825, 5011031, 2000612, 2000615, 2001345, 5016136, 2004001, 2002106, 2002110, 2006815, 2006435, 2006534, 5013229, 2000962, 2003265, 2008951, 2006680, 2008017, 2008269, 2008326, 2008397, 2008409, 5013379, 2009219, 2008952, 2001508, 5008056, 5016328, 2004169, 2005867, 5013249, 2001126, 5008054, 2007479, 2002402, 2002403, 5013629, 2001131, 2001288, 2001800, 2003080, 2003085, 2003099, 2003102, 2003128, 2003264, 2003272, 2005576, 5015102, 5015412, 5011702, 5015985, 2009228, 5011838, 5009718, 5008889, 2006030, 5014503, 2003888, 2002228, 5011320, 5012162, 5012166, 5014777, 2003978, 2004382, 2001291, 2000117, 2006556, 2003127, 5012928, 2004660, 2004804, 2006393, 2008416, 2008427, 2008614, 2004276, 2004392, 2006405, 2008429, 5014504, 5015981, 5013845, 5008676, 5007898, 5010752, 2007473, 5008908, 5015484, 5008677, 2005817, 2004015, 2005757, 2005911, 2005342, 2003945, 2003975, 2007467, 2003306, 2003922, 2006029, 2005830, 2003961, 2003131, 5013031, 2003885, 2003887, 2003886, 2001353, 2004008, 2004913, 2005993, 2003261, 2006891, 2005854, 2005750, 2004548, 2005353, 2002623, 2002656, 2002738, 2006805, 2003921, 2004041, 2005763, 2007812, 2008023, 2008025, 2008612, 2008863, 2008867, 2004927, 2006115.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0437-2026

Related Recalls

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

Oct 9, 2025 Diagnostic Equipment Nationwide View Details →