🔍 RecallPedia

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

Class I - Dangerous
🏥 Medical Devices Recalled: October 9, 2025 B-K Medical A/S Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN 05704916000264 and pending, Serial Numbers: 2002509, 2008698, 2006429, 5013043, 2008314, 2002617, 5016133, 5013054, 2005257, 2003097, 2003133, 2002655, 2001908, 2001567, 2001587, 5014656, 2001346, 2003432, 5015936, 5015937, 2007537, 2007493, 2007508, 2005573, 2003569, 2005652, 2002618, 5015938, 5015966, 2007534, 2005979, 2002510, 2003079, 2003083, 5013847, 2003532, 2003535, 5015614, 5015616, 5015617, 5015677, 5015720, 5015721, 5009669, 2003562, 5015927, 2001804, 5015611, 2008819, 2004819, 2004816, 2004939, 5016388, 5016390, 5009259, 5016395, 5015600, 5014860, 5008890, 5016164, 2000873, 2000878, 2000118, 2000880, 2001884, 5008010, 2003034, 5014063, 2006387, 5015116, 5010745, 5014406, 5014407, 5014408, 2008604, 5010979, 5010322, 5010408, 2003564, 2006191, 5014975, 2006407, 2005904, 2005920, 2006218, 5013389, 5011535, 2005357, 5011225, 2006894, 2005844, 2003526, 2003568, 5009258, 2005666, 2003923, 2009162, 2009149, 2008912, 2004177, 2004782, 2006039, 2005657, 2001916, 2001917, 5014174, 5008020, 2000876, 5015684, 5009371, 5009665, 2007644, 5011701, 5013040, 5014121, 5014655, 5014657, 5015225, 5015228, 5015924, 5015925, 2002652, 5012534, 2006422, 2007460, 2002405, 2001515, 2001516, 2004114, 2004438, 2008630, 2008811, 2003528, 2007507, 5015986, 2004121, 5014351, 2003434, 2006071, 2007573, 2006657, 2007540, 5016233, 5013794, 2001565, 2008024, 2008324, 5014992, 5016448, 2007466, 5015363, 2005816, 2005957, 2005964, 2006769, 2006829, 2001119, 2001122, 2003229, 2006112, 2006139, 2006203, 2005766, 2007346, 5016222, 2007602, 2009217, 2006457, 2008021, 2008178, 2002227, 2002229, 2002236, 2002237, 5015968, 5007860, 5007902, 5007909, 2001913, 5013051, 5013053, 5016235, 5011226, 2002649, 2003979, 2001583, 5010417, 2003081, 5013232, 5016491, 5016492, 2001123, 2003567, 2003570, 5009254, 5013770, 5015487, 5015491, 5009682, 5016185, 2002103, 2004052, 5016040, 2008930, 2001882, 2001909, 2002244, 5016418, 2003232, 2003259, 2005175, 2006402, 2006441, 2007343, 2007345, 2004840, 5016234, 5016236, 5016240, 5016336, 2002234, 5011170, 5015224, 2003098, 5016490, 5009256, 2003321, 2004594, 2003317, 2006159, 2001559, 2001566, 2001586, 2003563, 2005391, 5013027, 2004662, 2001513, 2006898, 2003101, 2007643, 2002243, 2002560, 2006746, 2008016, 2008706, 2003262, 2006409, 2002240, 2002561, 2002619, 2002624, 2006181, 2008012, 5010412, 5014507, 5015965, 2004690, 5012509, 5012513, 5013340, 5013341, 5009379, 5015686, 5015687, 5013587, 5013589, 5010705, 5013796, 2005762, 2008264, 2008291, 2000792, 2000793, 2000794, 2000795, 2000797, 2000961, 2000967, 2000970, 2000725, 2002238, 2001285, 2008890, 5014730, 5016029, 2000958, 2002111, 2004813, 5014506, 2002241, 2003323, 5013390, 2001449, 2006477, 2002504, 5015722, 5016172, 2007474, 2003530, 2008641, 2001802, 5012455, 5008837, 5008886, 2003258, 2003130, 5014247, 5016396, 5016402, 5016403, 5016404, 5013848, 5015496, 5012852, 5012854, 5014350, 5015230, 5015250, 2002734, 2001560, 2001562, 2001563, 5008008, 2004496, 5016182, 2003982, 5008771, 5010418, 2006390, 2002109, 2004208, 2004678, 5016344, 2006301, 5016041, 5015967, 2007341, 5016183, 2008823, 2004808, 2007458, 5008885, 5008887, 2007532, 5016339, 5010982, 5009370, 5010976, 2008583, 2008615, 5012851, 5009496, 5016337, 2004188, 5013316, 5016414, 5016223, 5015497, 5015612, 5013916, 5013917, 2000872, 2004526, 2005448, 2002164, 2005847, 5014829, 2000955, 2000722, 2001582, 2000611, 2001116, 2000721, 2001347, 2003231, 2000874, 5016242, 5016243, 2000614, 2003319, 2000119, 5009679, 5014374, 2000660, 2004523, 5015227, 5014234, 2008610, 2008632, 2008853, 5009681, 5015493, 5009509, 2007323, 2007480, 2007487, 5011167, 2001130, 5014843, 5007892, 5011250, 5008005, 5008017, 5008668, 2006350, 2002505, 2002955, 2003233, 2003430, 2003431, 2003905, 2003985, 2004542, 2004760, 2004775, 2004907, 2005921, 2003263, 2003320, 2003529, 2003318, 2002622, 2004911, 2007715, 2001878, 2001880, 2001883, 2001886, 2004205, 2008924, 2008177, 2008004, 2008022, 2005376, 5014375, 2005550, 2005274, 2001512, 2006017, 2004085, 2000881, 2003256, 2005582, 2005753, 2003884, 5012528, 2003322, 5015045, 5015108, 5012079, 5012163, 2001799, 5011321, 5016126, 5016413, 5016427, 2004815, 2003920, 2003960, 2005538, 2005545, 5015399, 2001127, 2001564, 2006335, 2001348, 5014658, 5013583, 2005423, 2000664, 5016383, 2000799, 2000800, 2006106, 5015226, 2000618, 2000965, 2008961, 2001124, 2001286, 2001806, 2004776, 2004821, 2005643, 5012252, 5011929, 2006187, 5009582, 2000971, 2000728, 2000730, 5008896, 5016167, 5015046, 5012665, 5011333, 2000619, 2006482, 2002621, 2001578, 5011930, 2006463, 2001885, 2003260, 5013615, 5011330, 2004645, 2000729, 2002939, 2005808, 2004661, 2006419, 2001457, 2000616, 5013356, 5010997, 5014064, 2004924, 2000724, 2004569, 2001352, 5015257, 2002653, 2003435, 5011000, 5014176, 2000668, 5008894, 5011927, 5013630, 5015982, 2004502, 5015607, 5015608, 5015403, 5014991, 5014859, 2006531, 5013357, 5012077, 2002107, 2004115, 5009660, 2003428, 5010211, 2004029, 2009209, 5015486, 5013248, 5015113, 2006836, 5016121, 5013631, 5015402, 5013776, 5015110, 2003226, 5015038, 2006466, 5015689, 2004666, 2001125, 5009373, 2004806, 5016105, 5014846, 2000617, 5008013, 2007500, 5012590, 2007510, 5014787, 2004607, 2004669, 2001290, 5008884, 5015361, 2001292, 2001580, 2002961, 5008883, 2001113, 2000791, 2006190, 2003436, 2004818, 2004914, 2005162, 2000610, 5011829, 5011836, 5011326, 2006781, 5010998, 5010999, 5015613, 2000966, 5007751, 5010698, 5014505, 5013846, 2006565, 2007494, 2001801, 5015375, 5015609, 2004856, 2004916, 5014852, 5016263, 2004110, 5008002, 5015984, 2003104, 5014108, 2004076, 5009683, 5014175, 2000669, 5014177, 2003994, 2007471, 2007543, 2008015, 2008311, 2008322, 2008331, 2008344, 2008405, 2008432, 2008619, 2008627, 2008699, 2008860, 2008865, 2008926, 5012662, 5015604, 5014243, 5015400, 2002648, 2000663, 5016276, 2003135, 5016326, 5016327, 2000726, 5009372, 2004011, 2005408, 5013616, 2002737, 2005006, 5015039, 2000877, 5009670, 2001510, 2004027, 2004034, 2001805, 2004676, 5015964, 5015685, 5015043, 5016226, 2002362, 2007574, 2006042, 5010992, 2008342, 2008596, 2003132, 5013380, 5011533, 2006675, 2001511, 2000953, 2002956, 2003103, 2003126, 2003576, 2006544, 2007366, 5013230, 5015610, 5015934, 5016184, 2001452, 2004079, 2004932, 5016039, 5016221, 5009595, 5010210, 5007895, 2003566, 2000661, 5016224, 5013033, 5014246, 2002964, 5013038, 5016266, 2004778, 5011324, 5013614, 5008195, 5014289, 2000727, 5014178, 5016335, 5015413, 5015414, 2000875, 5015602, 5012859, 5016288, 5007063, 5014109, 5015601, 2003534, 2003325, 5016106, 2005937, 2001289, 2001581, 2002226, 2002741, 2002743, 2003889, 2004003, 2004196, 2004759, 2004837, 5009247, 5009658, 5010776, 5012532, 5013777, 5014245, 5014659, 5014976, 5015485, 5015488, 5015490, 5015926, 5016289, 2002647, 2001454, 5009672, 5013582, 5015401, 5012855, 2008939, 5015251, 5015255, 5015256, 5015258, 2004570, 5015407, 5012652, 5012600, 2000662, 2002411, 2004677, 2008644, 2000665, 2001912, 2002408, 2002958, 2003977, 2004043, 2005586, 2005806, 2005877, 2007813, 5013795, 2000723, 2000964, 2002108, 2002231, 2002625, 2005349, 2007465, 2008392, 2008403, 5016137, 5016165, 5016166, 2001117, 2004087, 2004436, 2004606, 2004659, 2004844, 2004915, 2004918, 2006013, 2006031, 2006083, 2006086, 2006321, 2006376, 2006399, 2006412, 2006444, 2006447, 2006452, 2006461, 2007586, 2007866, 2008599, 2008270, 2008260, 2008608, 2008875, 2008956, 2008304, 2008293, 2008305, 2008317, 2008329, 2000116, 2000968, 2000969, 2001351, 2002736, 2003227, 2004213, 2004384, 2005560, 2006040, 2008020, 5009364, 5010419, 5014778, 5015378, 5016227, 2007327, 2007364, 2007469, 2007472, 2002105, 2002513, 2004475, 2008442, 5013320, 5013321, 2002740, 2001287, 2001293, 2001294, 2001585, 2002239, 2004086, 5013782, 5012247, 5012249, 2005789, 2005016, 5010985, 5010989, 5010410, 2008818, 2001910, 2001121, 2001129, 2003316, 2005370, 2005647, 2006799, 2002940, 2005552, 2007639, 2008895, 5014788, 5016244, 2004002, 2005415, 5010747, 5011322, 5014725, 5014726, 5012927, 2004934, 5008189, 2005454, 2007344, 2006027, 2006748, 2008028, 2008398, 5009253, 2006016.
  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:

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

Product Codes/Lot Numbers:

GTIN 05704916000264 and pending, Serial Numbers: 2002509, 2008698, 2006429, 5013043, 2008314, 2002617, 5016133, 5013054, 2005257, 2003097, 2003133, 2002655, 2001908, 2001567, 2001587, 5014656, 2001346, 2003432, 5015936, 5015937, 2007537, 2007493, 2007508, 2005573, 2003569, 2005652, 2002618, 5015938, 5015966, 2007534, 2005979, 2002510, 2003079, 2003083, 5013847, 2003532, 2003535, 5015614, 5015616, 5015617, 5015677, 5015720, 5015721, 5009669, 2003562, 5015927, 2001804, 5015611, 2008819, 2004819, 2004816, 2004939, 5016388, 5016390, 5009259, 5016395, 5015600, 5014860, 5008890, 5016164, 2000873, 2000878, 2000118, 2000880, 2001884, 5008010, 2003034, 5014063, 2006387, 5015116, 5010745, 5014406, 5014407, 5014408, 2008604, 5010979, 5010322, 5010408, 2003564, 2006191, 5014975, 2006407, 2005904, 2005920, 2006218, 5013389, 5011535, 2005357, 5011225, 2006894, 2005844, 2003526, 2003568, 5009258, 2005666, 2003923, 2009162, 2009149, 2008912, 2004177, 2004782, 2006039, 2005657, 2001916, 2001917, 5014174, 5008020, 2000876, 5015684, 5009371, 5009665, 2007644, 5011701, 5013040, 5014121, 5014655, 5014657, 5015225, 5015228, 5015924, 5015925, 2002652, 5012534, 2006422, 2007460, 2002405, 2001515, 2001516, 2004114, 2004438, 2008630, 2008811, 2003528, 2007507, 5015986, 2004121, 5014351, 2003434, 2006071, 2007573, 2006657, 2007540, 5016233, 5013794, 2001565, 2008024, 2008324, 5014992, 5016448, 2007466, 5015363, 2005816, 2005957, 2005964, 2006769, 2006829, 2001119, 2001122, 2003229, 2006112, 2006139, 2006203, 2005766, 2007346, 5016222, 2007602, 2009217, 2006457, 2008021, 2008178, 2002227, 2002229, 2002236, 2002237, 5015968, 5007860, 5007902, 5007909, 2001913, 5013051, 5013053, 5016235, 5011226, 2002649, 2003979, 2001583, 5010417, 2003081, 5013232, 5016491, 5016492, 2001123, 2003567, 2003570, 5009254, 5013770, 5015487, 5015491, 5009682, 5016185, 2002103, 2004052, 5016040, 2008930, 2001882, 2001909, 2002244, 5016418, 2003232, 2003259, 2005175, 2006402, 2006441, 2007343, 2007345, 2004840, 5016234, 5016236, 5016240, 5016336, 2002234, 5011170, 5015224, 2003098, 5016490, 5009256, 2003321, 2004594, 2003317, 2006159, 2001559, 2001566, 2001586, 2003563, 2005391, 5013027, 2004662, 2001513, 2006898, 2003101, 2007643, 2002243, 2002560, 2006746, 2008016, 2008706, 2003262, 2006409, 2002240, 2002561, 2002619, 2002624, 2006181, 2008012, 5010412, 5014507, 5015965, 2004690, 5012509, 5012513, 5013340, 5013341, 5009379, 5015686, 5015687, 5013587, 5013589, 5010705, 5013796, 2005762, 2008264, 2008291, 2000792, 2000793, 2000794, 2000795, 2000797, 2000961, 2000967, 2000970, 2000725, 2002238, 2001285, 2008890, 5014730, 5016029, 2000958, 2002111, 2004813, 5014506, 2002241, 2003323, 5013390, 2001449, 2006477, 2002504, 5015722, 5016172, 2007474, 2003530, 2008641, 2001802, 5012455, 5008837, 5008886, 2003258, 2003130, 5014247, 5016396, 5016402, 5016403, 5016404, 5013848, 5015496, 5012852, 5012854, 5014350, 5015230, 5015250, 2002734, 2001560, 2001562, 2001563, 5008008, 2004496, 5016182, 2003982, 5008771, 5010418, 2006390, 2002109, 2004208, 2004678, 5016344, 2006301, 5016041, 5015967, 2007341, 5016183, 2008823, 2004808, 2007458, 5008885, 5008887, 2007532, 5016339, 5010982, 5009370, 5010976, 2008583, 2008615, 5012851, 5009496, 5016337, 2004188, 5013316, 5016414, 5016223, 5015497, 5015612, 5013916, 5013917, 2000872, 2004526, 2005448, 2002164, 2005847, 5014829, 2000955, 2000722, 2001582, 2000611, 2001116, 2000721, 2001347, 2003231, 2000874, 5016242, 5016243, 2000614, 2003319, 2000119, 5009679, 5014374, 2000660, 2004523, 5015227, 5014234, 2008610, 2008632, 2008853, 5009681, 5015493, 5009509, 2007323, 2007480, 2007487, 5011167, 2001130, 5014843, 5007892, 5011250, 5008005, 5008017, 5008668, 2006350, 2002505, 2002955, 2003233, 2003430, 2003431, 2003905, 2003985, 2004542, 2004760, 2004775, 2004907, 2005921, 2003263, 2003320, 2003529, 2003318, 2002622, 2004911, 2007715, 2001878, 2001880, 2001883, 2001886, 2004205, 2008924, 2008177, 2008004, 2008022, 2005376, 5014375, 2005550, 2005274, 2001512, 2006017, 2004085, 2000881, 2003256, 2005582, 2005753, 2003884, 5012528, 2003322, 5015045, 5015108, 5012079, 5012163, 2001799, 5011321, 5016126, 5016413, 5016427, 2004815, 2003920, 2003960, 2005538, 2005545, 5015399, 2001127, 2001564, 2006335, 2001348, 5014658, 5013583, 2005423, 2000664, 5016383, 2000799, 2000800, 2006106, 5015226, 2000618, 2000965, 2008961, 2001124, 2001286, 2001806, 2004776, 2004821, 2005643, 5012252, 5011929, 2006187, 5009582, 2000971, 2000728, 2000730, 5008896, 5016167, 5015046, 5012665, 5011333, 2000619, 2006482, 2002621, 2001578, 5011930, 2006463, 2001885, 2003260, 5013615, 5011330, 2004645, 2000729, 2002939, 2005808, 2004661, 2006419, 2001457, 2000616, 5013356, 5010997, 5014064, 2004924, 2000724, 2004569, 2001352, 5015257, 2002653, 2003435, 5011000, 5014176, 2000668, 5008894, 5011927, 5013630, 5015982, 2004502, 5015607, 5015608, 5015403, 5014991, 5014859, 2006531, 5013357, 5012077, 2002107, 2004115, 5009660, 2003428, 5010211, 2004029, 2009209, 5015486, 5013248, 5015113, 2006836, 5016121, 5013631, 5015402, 5013776, 5015110, 2003226, 5015038, 2006466, 5015689, 2004666, 2001125, 5009373, 2004806, 5016105, 5014846, 2000617, 5008013, 2007500, 5012590, 2007510, 5014787, 2004607, 2004669, 2001290, 5008884, 5015361, 2001292, 2001580, 2002961, 5008883, 2001113, 2000791, 2006190, 2003436, 2004818, 2004914, 2005162, 2000610, 5011829, 5011836, 5011326, 2006781, 5010998, 5010999, 5015613, 2000966, 5007751, 5010698, 5014505, 5013846, 2006565, 2007494, 2001801, 5015375, 5015609, 2004856, 2004916, 5014852, 5016263, 2004110, 5008002, 5015984, 2003104, 5014108, 2004076, 5009683, 5014175, 2000669, 5014177, 2003994, 2007471, 2007543, 2008015, 2008311, 2008322, 2008331, 2008344, 2008405, 2008432, 2008619, 2008627, 2008699, 2008860, 2008865, 2008926, 5012662, 5015604, 5014243, 5015400, 2002648, 2000663, 5016276, 2003135, 5016326, 5016327, 2000726, 5009372, 2004011, 2005408, 5013616, 2002737, 2005006, 5015039, 2000877, 5009670, 2001510, 2004027, 2004034, 2001805, 2004676, 5015964, 5015685, 5015043, 5016226, 2002362, 2007574, 2006042, 5010992, 2008342, 2008596, 2003132, 5013380, 5011533, 2006675, 2001511, 2000953, 2002956, 2003103, 2003126, 2003576, 2006544, 2007366, 5013230, 5015610, 5015934, 5016184, 2001452, 2004079, 2004932, 5016039, 5016221, 5009595, 5010210, 5007895, 2003566, 2000661, 5016224, 5013033, 5014246, 2002964, 5013038, 5016266, 2004778, 5011324, 5013614, 5008195, 5014289, 2000727, 5014178, 5016335, 5015413, 5015414, 2000875, 5015602, 5012859, 5016288, 5007063, 5014109, 5015601, 2003534, 2003325, 5016106, 2005937, 2001289, 2001581, 2002226, 2002741, 2002743, 2003889, 2004003, 2004196, 2004759, 2004837, 5009247, 5009658, 5010776, 5012532, 5013777, 5014245, 5014659, 5014976, 5015485, 5015488, 5015490, 5015926, 5016289, 2002647, 2001454, 5009672, 5013582, 5015401, 5012855, 2008939, 5015251, 5015255, 5015256, 5015258, 2004570, 5015407, 5012652, 5012600, 2000662, 2002411, 2004677, 2008644, 2000665, 2001912, 2002408, 2002958, 2003977, 2004043, 2005586, 2005806, 2005877, 2007813, 5013795, 2000723, 2000964, 2002108, 2002231, 2002625, 2005349, 2007465, 2008392, 2008403, 5016137, 5016165, 5016166, 2001117, 2004087, 2004436, 2004606, 2004659, 2004844, 2004915, 2004918, 2006013, 2006031, 2006083, 2006086, 2006321, 2006376, 2006399, 2006412, 2006444, 2006447, 2006452, 2006461, 2007586, 2007866, 2008599, 2008270, 2008260, 2008608, 2008875, 2008956, 2008304, 2008293, 2008305, 2008317, 2008329, 2000116, 2000968, 2000969, 2001351, 2002736, 2003227, 2004213, 2004384, 2005560, 2006040, 2008020, 5009364, 5010419, 5014778, 5015378, 5016227, 2007327, 2007364, 2007469, 2007472, 2002105, 2002513, 2004475, 2008442, 5013320, 5013321, 2002740, 2001287, 2001293, 2001294, 2001585, 2002239, 2004086, 5013782, 5012247, 5012249, 2005789, 2005016, 5010985, 5010989, 5010410, 2008818, 2001910, 2001121, 2001129, 2003316, 2005370, 2005647, 2006799, 2002940, 2005552, 2007639, 2008895, 5014788, 5016244, 2004002, 2005415, 5010747, 5011322, 5014725, 5014726, 5012927, 2004934, 5008189, 2005454, 2007344, 2006027, 2006748, 2008028, 2008398, 5009253, 2006016.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0440-2026

Related Recalls

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

B-K Medical A/S

Class I - Dangerous

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 →