CareFusion 303, Inc. BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01
Brand
CareFusion 303, Inc.
Lot Codes / Batch Numbers
REF/UDI-DI: 323/10885403512667, 352/10885403512674, 327/10885403477836, 1116-00/10885403512605 Software Version: ES 1.7.x Serial Numbers: 13534745, 16220738, 16446299, 16446303, 16446302, 16247443, 16247440, 15962990, 16417275, 16446297, 16446296, 16242783, 16234266, 15425093, 16446295, 16446291, 16242784, 16417277, 15644176, 14019332, 16212329, 16221517, 16395857, 16059358, 16254191, 15319466, 15154945, 15153602, 16215325, 15154942, 14959051, 16395855, 16395853, 16215313, 16361893, 14826969, 14826972, 14826971, 14826973, 14232856, 16241342, 13877154, 15148881, 15148860, 15148880, 15148882, 15854601, 15148883, 15148865, 15148885, 15160417, 16212961, 15854595, 15148859, 15148862, 15148861, 15148863, 15148866, 15148868, 15854596, 15854600, 15148870, 15854597, 15854598, 15854599, 15148873, 15148864, 15148867, 15148884, 15148878, 15148879, 16324054, 16223557, 15136666, 13841400, 14138516, 15519749, 16446315, 16141586, 16416617, 16416618, 16416622, 16416619, 16416621, 16416623, 16416616, 16416615, 13781497, 14557551, 16212312, 15500549, 14700155, 16212346, 16214431, 16214432, 16214430, 16214429, 16212344, 16247441, 16247444, 16320157, 16335215, 16204472, 15154938, 14813899, 14697245, 15642731, 16209866, 15135154, 16214435, 16446294, 16227849, 16446311, 16010961, 16375509, 15303370, 16415510, 14668921, 16239128, 16346806, 16242800, 16204479, 16352591, 16324052, 16222213, 16212322, 16271477, 15015227, 16214427, 16373774, 15978927, 16358533, 16215391, 16446313, 16446308, 16247439, 16247445, 16247442, 16347745, 16347746, 14157588, 16271458, 16346807, 15196235, 16322403, 16352593, 14728645, 16212338, 15519703, 16217225, 14806556, 16352598, 16352590, 16352595, 16352596, 15263493, 16216425, 16416639, 16416102, 16416104, 16416632, 16416108, 16416637, 16416110, 16416111, 16416106, 16416638, 14987500, 16234192, 16405456, 16405459, 15136661, 16242578, 16271457, 15911127, 15954728, 16271463, 16271465, 14966741, 16214437, 16324055, 16225327, 16407028, 14613489, 15997584, 14442210, 16357615, 16357616, 16307328, 13839287, 13839299, 15136665, 15045814, 16054085, 15642724, 16244068, 16346335, 16283945, 16231509, 16277495, 16240201, 16211337, 16291566, 16212335, 15933030, 16242781, 16346808, 15135153, 16204480, 16271460, 16212330, 16324056, 16215395, 16214434, 15454500, 16173369, 16423187, 15895362, 16242797, 16204482, 16274624, 16223058, 16223059, 16274625, 15540317, 16223060, 16274626, 16257759, 16352588, 16446301, 12345678, 16271461, 16352594, 16212342, 16120462, 16235542, 16242799, 16212336, 16468210, 16195795, 16211170, 15570657, 16223556, 16412617, 16412618, 16412615, 16412616, 16321316, 16022041, 16242801, 16267770, 15136667, 15136668, 16174009, 14956271, 15236068, 15236067, 16218170, 16061265, 14572826, 16128483, 16128482, 16143915, 15398129, 15449307, 16174023, 16174021, 16143913, 16174036, 16174008, 16174019, 16174020, 15449302, 15691588, 15449303, 16227720, 16446290, 16242780, 16242802, 16405462, 16116814, 16212339, 16008937, 16215393, 16215389, 16215398, 16223558, 15147150, 16342242, 16253003, 16253008, 15495195, 16149377, 16094701, 15560137, 16296089, 16296090, 16296091, 16296092, 13347728, 14826153, 16417216, 16417243, 16417242, 16324044, 16415642, 16419185, 16415641, 16415639, 16415640, 16242803, 16242804, 16212319, 15136664, 16262416, 15136663, 16317160, 16212343, 15136670
Products Sold
REF/UDI-DI: 323/10885403512667, 352/10885403512674, 327/10885403477836, 1116-00/10885403512605 Software Version: ES 1.7.x Serial Numbers: 13534745, 16220738, 16446299, 16446303, 16446302, 16247443, 16247440, 15962990, 16417275, 16446297, 16446296, 16242783, 16234266, 15425093, 16446295, 16446291, 16242784, 16417277, 15644176, 14019332, 16212329, 16221517, 16395857, 16059358, 16254191, 15319466, 15154945, 15153602, 16215325, 15154942, 14959051, 16395855, 16395853, 16215313, 16361893, 14826969, 14826972, 14826971, 14826973, 14232856, 16241342, 13877154, 15148881, 15148860, 15148880, 15148882, 15854601, 15148883, 15148865, 15148885, 15160417, 16212961, 15854595, 15148859, 15148862, 15148861, 15148863, 15148866, 15148868, 15854596, 15854600, 15148870, 15854597, 15854598, 15854599, 15148873, 15148864, 15148867, 15148884,15148878, 15148879, 16324054, 16223557, 15136666, 13841400, 14138516, 15519749, 16446315, 16141586, 16416617, 16416618, 16416622, 16416619, 16416621, 16416623, 16416616, 16416615, 13781497, 14557551, 16212312, 15500549, 14700155, 16212346, 16214431, 16214432, 16214430, 16214429, 16212344, 16247441, 16247444, 16320157, 16335215, 16204472, 15154938, 14813899, 14697245, 15642731, 16209866, 15135154, 16214435, 16446294, 16227849, 16446311, 16010961, 16375509, 15303370, 16415510, 14668921, 16239128, 16346806, 16242800, 16204479, 16352591, 16324052, 16222213, 16212322, 16271477, 15015227, 16214427, 16373774, 15978927, 16358533, 16215391, 16446313, 16446308, 16247439, 16247445, 16247442, 16347745, 16347746, 14157588, 16271458, 16346807, 15196235, 16322403, 16352593, 14728645, 16212338, 15519703, 16217225, 14806556, 16352598, 16352590, 16352595, 16352596, 15263493, 16216425, 16416639, 16416102, 16416104, 16416632, 16416108, 16416637, 16416110, 16416111, 16416106, 16416638, 14987500, 16234192, 16405456, 16405459, 15136661, 16242578, 16271457, 15911127, 15954728, 16271463, 16271465, 14966741, 16214437, 16324055, 16225327, 16407028, 14613489, 15997584, 14442210, 16357615, 16357616, 16307328, 13839287, 13839299, 15136665, 15045814, 16054085, 15642724, 16244068, 16346335, 16283945, 16231509, 16277495, 16240201, 16211337, 16291566, 16212335, 15933030, 16242781, 16346808, 15135153, 16204480, 16271460, 16212330, 16324056, 16215395, 16214434, 15454500, 16173369, 16423187, 15895362, 16242797, 16204482, 16274624, 16223058, 16223059, 16274625, 15540317, 16223060, 16274626, 16257759, 16352588, 16446301, 12345678, 16271461, 16352594, 16212342, 16120462, 16235542, 16242799, 16212336, 16468210, 16195795, 16211170, 15570657, 16223556, 16412617, 16412618, 16412615, 16412616, 16321316, 16022041, 16242801, 16267770, 15136667, 15136668, 16174009, 14956271, 15236068, 15236067, 16218170, 16061265, 14572826, 16128483, 16128482, 16143915, 15398129, 15449307, 16174023, 16174021, 16143913, 16174036, 16174008, 16174019, 16174020, 15449302, 15691588, 15449303, 16227720, 16446290, 16242780, 16242802, 16405462, 16116814, 16212339, 16008937, 16215393, 16215389, 16215398, 16223558, 15147150, 16342242, 16253003, 16253008, 15495195, 16149377, 16094701, 15560137, 16296089, 16296090, 16296091, 16296092, 13347728, 14826153, 16417216, 16417243, 16417242, 16324044, 16415642, 16419185, 16415641, 16415639, 16415640, 16242803, 16242804, 16212319, 15136664, 16262416, 15136663, 16317160, 16212343, 15136670
CareFusion 303, Inc. is recalling BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: due to If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.
Recommended Action
Per FDA guidance
On 6/6/24, correction notices were distributed to customers who were informed that their devices had been remediated. That they had been contacted by phone in May 2024 to schedule device remediation. The firm re-configured the component manager from "installed mode" to "disabled mode" and checked if the Microsoft patch was present on each device. If the patch was identified on a device, it was removed. All devices were then configured to "managed mode" and rebooted to enable the system appropriately. Customers are asked to complete and return the response form to Email BDRC15@bd.com For safety information about the system not covered in this document, call the firm's Technical Support Center at 1-800-727-6102, Phone hours: 24 hours, 7 days a week. Additional contacts include: 1) Regional Complaint Center, 1-844-823-5433 Say "Product Complaints" when prompted Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com 2) Post Market Quality Field Action Operations, BDRC15@bd.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026