CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
BD EpiCenter Microbiology Data Management System recalled
Becton Dickinson & is recalling BD EpiCenter Microbiology Data Management System, labeled as the following: Computer, distributed nationwide in the US. The recall was initiated on 23 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0235-2026
- FDA event ID
- 97479
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Sep 2025
- FDA classified
- 23 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Sep 2025 | Recall initiated by company | |
| 23 Oct 2025 | Classified by FDA | +30 days |
| 29 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Product as listed by the FDA
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
Where it was distributed
Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.
Questions about this recall
Is BD EpiCenter Microbiology Data Management System, labeled as the following: Computer recalled?
Yes. Becton Dickinson & recalled BD EpiCenter Microbiology Data Management System, labeled as the following: Computer on 23 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0235-2026.
Why was it recalled?
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Which lots are affected?
1. Catalog Number: 441002; UDI/DI: 00382904410025; Serial Numbers: MXL8503690, 5xlz833, HCT26Q3, FB3D7F3, MY816005EF, EPSN0443, EPSN0445, EPSN0496, EPSN0500, 4WMW9R2, EPSN0509, EPSN0480, MXL8501ST4, 274kdz0276, 4CDFTJ1, 2PGX5V1, EPSN0484, EPSN0485, EPSN0486, EPSN0492, EPSN0494, EPSN0497, EPSN0498, EPSN0499, EPSN0462, EPSN0463, 5W5S252, 553H5M1, 9JG1M51, 9HB2H41, 4113NM1, 80KTQ02, 30KXLM1, EPSN0450, EPSN0451, EPSN0453, EPSN0456, EPSN0458, 550PS81, EPSN0466, EPSN0467, 8D00GY1, EPSN0469, EPSN0470, EPSN0471, EPSN0472, EPSN0474, 5TGRCP1, 5DSNS81, 4173NM1, H94Y7S1, CQZL2V1, 7ZFCPH1, H3VV7R1, 9OF0030, 107326, 107875, 107558, SNYHN1, 44YP282, 6CPBY02, EPSN0476, 2Y71FQ1, BRJ4197MTK, 5FCQ491, SNCB4Y7S1, 8S6Q2V1, JHL1ZD1, DZFCPH1, MXL7411G1W, F5S30B1, 8HR4W1, EPIDB6768, 11XTJQ1, EPISAM1, 3CR33002FV, JR5002013067, EPSN0510, EPSN0511, FT3841EPI, MXL5371H1F, MXL7411G1D, MXL7411G1Q, MXL7411G1N, MXL7191DW4, MLX7191DWQ, MLX7191DWW, MXL6191BM8, 48D2NM1, UB3788EPI5, MXL209140T, X1693649, EPSN0514, EPSN0516, EPSN0517, EPSN0520, EPSN0522, EPSN0523, EPSN0530, MXL72820P9, EPSN0532, EPSN0533, EPSN0534, EPSN0535, EPSN0536, EPSN0541, EPSN0543, EPSN0545, SAA70907WL, EPSN0558, EPSN0559, MXL922203Y, EPSN0560, EPSN0561, MXL9221PDD, EPSN0563, MXL9221PD3, EPSN0564, MXL9221PFW, EPSN0566, EPSN0567, EPSN0568, JR5002017009, 8CG927017D, 6ZNP1R1, MXL7520PM2, Epitraum, Epicenter PC Server, EPSN0550, EPSN0555, 9DK0C42, 5JWPCP1, EPSN0570, EPSN0572, 27PHT13, EPSN0573, EPSN0574, 46H8DH2, EPSN0575, MXL74413VS, EPSN0577, HQRL842, EPSN0578, QAZ123WSX, EPSN0579, BCTGDH2, EPSN0580, MXL7411GHJ, MXL7411GF7, MXL7411GH2, MXL7411GDY, MXL744159T, MXL7411GJZ, MXL850369Z, MXL85036TY, MXL9123R03, 18303, MXL9123R1L, mxl74413v7, EPSN0586, MP1523UE, EPSN0587, MXL74411QH, EPSN0588, 9SDZLP2, EPSN0589, 3CQ7Z03, EPSN0591, MXL85035W4, EPSN0592, MP1F459S, EPSN0594, B6PHT13, EPSN0590, MXL82219X9, EPSN0597, 6PZG833, DCQ7Z03, 6NZG833, 9NZG833, F4V9DZ1S2, BCSPDH2, MY735009LU, H217CH2, MY735009MS, MY737009LE, G6YE5330006W, 6ZQM1R1, 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E4PFAG000PUT, D4PFAG000CZ5, C9PFAG000TAL, GK7162S, 3N5VXBX, H69JJS1, D4PFAG000CZE, 19C9S1S, C3PFAG0015AL, C9PFAG000TBH, F2PFAG0001HX, 27HRQ1S, E9PFAG000CEB, 93FNY1S, E4PFAG000PV1, D4PFAG000CZ4, 74BVB1S, 183R5V1, BLKVJM1, 5FG1M51, JHB2H41, 961ZWL1, 5VCLS81, 48L2NM1, E108281751000001, G6YE54800198, DQMYD2S, FYXMN1, IRZV8X1, GTR30B1, 9LNCY1S, 1V7LF41, CQMYD2S, 6ZMZ1R1, 76NQD2S, FVC5UTY, BZ8NZ1S, 4V39M1S, H197K02, FZ02MN1, FVCLS81, 75S30B1, MXL6450Y0L, MJ0HWHN5, 1CZ214021V, MJOHWHPW, 1CZ23005YD, 1CZ11404XF, MJ09Z5BM, 1CZ1190H0G, MXL9221ZW9, 2KDNS91, 3CSNS81, 853H5M1, HQ4NHBX, 8N3RPBX, YE5330002P, 6FSNS81, MY735009X9, BQ8LS91, 5JXKCP1, YE548000C9, H8G73N2, H8G93N2, FD9XFP2, 66W2QK2, 6ZRK1R1, H0X9K02, H177K02, H17BK02, H1B8K02, 6737QK2, 6750QK2, H8F53N2, 532799-0, 550650-1, 95K172, 44YS282, 1FGFX12, 1FJQZZ1, 1JMCRBX, 1Q82LY1, 26PSWBX, 2JMCRBX, 3HMVXBX, 3ZSMYBX, 4JJQZZ1, 56PSWBX, 6R82LY1, 6ZSMYBX, 7JJQZZ1, 82NS032, 84LBWBX, 9N3RPBX, BQ82LY1, C1XX2Y1, CJJQZZ1, DQ82LY1, DYSMYBX, G453TBX, GDJQZZ1, GLJQZZ1, GV1XMBX, H453TBX, J2NS032, JHJQZZ1, 1BYKPS1, 1X8JX12, H167K02, G6YE548000CZ, 66ZTX12, 42NS032, YE50200075E, 1BWVPS1, 5THPCP1, 1FDFX12, 35CQL02, 5MJQZZ1, G6Y548000065, G6YE50200750, G6YE5020079Z, YE5330005D, 6J3BHZ1, G6YE5020076M, YE5480000F, 9ZHY032, G6YE50200AP9, 43NS032, HDYYQ12, B6V5HD2, G6YE548000MP, MXL82219XK, 6P62N63, G6YE548000A5, HZ4HPC3, 5YFH1D3, 36PHT13, MXL04831YD, 5CXSJQ1, YE548000CX, MY816005J2, MY709008L0, FYXPMN1, MY827004ZM, MY709007L5, EPSN0261, EPSN0264, EPSN0266, EPSN0267, EPSN0268, EPSN0269, EPSN0270, BD41ZQ1, EPSN0271, MY737009L0, YE5020077Z, YE502009CJ, YE5020075S, BS1CHBX, GQ4NHBX, 92KLJBX, YE548000CY, G6YE502007VZ, DYHY032, GHMCRBX, G6YE5480000D, YE548000A6, G6YE502007AK, 7GB2H41, 30QYKM1, 48H0NM1, 30XYKM1, 1ZSMYBX, 30YKM1, FYW0MN1, 670HX12, 2M03FQ1, 1XDRX12, FJDNS91, 86S30B1, 1F8RX12, 8GQZMS1, 1F8GX12, 14CK8Z1, 9D2G5N3, 351SL02, 64Y2VG1, 353ML02, 13ZL8Z1, A2XKS22, 1W4DM1S, 2P9W5V1, 26GN9Y1, 6ZQL1R1, 13CHXR1, 1R2V8X1, 99Q24V1, 8GV0NS1, 37KRDC1, G1WRDC1, FKZGN22, F1WRDC1, MJPZNNZ, C1WRDC1, BYHC9BX, 8GQ0NS1, 3N5Y032, 13GFXR1, 5V0YJ32, JL70K32, 2N5Y032, 2NVR5V1, BL70K32, HV0YJ32, 57KRDC1, PENDING, F1YWH1S, J29Y032, 9DJW3V1, G6MY729000K2, 621HG62, DT0YJ32, 4N5Y032, 7L70K32, G1ZVMS1, 6050R52, BRNGRBX, 626OR52, DL70K32, 3DL7LF1, BSQJVBX, 1N5Y032, 9K70K32, 46S30B1, FL70K32, 99SY3V1, 67RXFC1, HHL7LF1, H7RXHC1, 353NL02, B7LYUBX, 25DIYBX, 24PVJ32, H4PVJ32, 9WNT032, 8FJBS22, 4XWJS22, 82YKS22, 9B824V1, 42WRDC1, GK8RDC1, FKXGN22, H6BLJS1, 4Y19S22, 831KS22, FKTSN22, 9DVX3V1, BD53ZQ1, 2NJS5V1, 93Z5QC1, 1BZNPS1, HZL6QC1, HK8RDC1, 9DDW3V1, 9B404B1, FGTL6D1, BZL6QC1, 4J565D1, DGTL6B1, 4JL7LF1, GZNL1R1, HFTL6D1, DDL7LF1, FDL7LF1, 364NL02, CXSL6D1, 99RW3V1, 83Z5QC1, 1X9TX12, 1P571F1, FDCTFP2, 1BTKPS1, 6R571S1, 71GH6Y1, 1V92BG1, BL866T, 95BD8D1, 6982BG1, BWHJWH1, BL32VG1, 9V92BG1, 182Y5V1, G6MY646007ZK, GL32VG1, 2NVZ5V1, F2DX301, F4Y2VG1, 4XWMS22, 14HL8Z1, GYQN301, 2NTQ5V1, 1XHJWH1, 2PJT5V1, 8FVSM01, EPSN0014, EPSN0094, EPSN0153, 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71FK6Y1, 78NLLJ1, EPSN0187, DPNKLJ1, EPSN0211, EPSN0041, EPSN0046, EPSN0013, EPSN0184, 4-SYK382, EPSN0224, EPSN0055, EPSN0116, EPSN0091, EPSN0063, EPSN0210, EPSN0078, EPSN0161, EPSN0043, EPSN0225, 452W482, EPSN0217, 451R482, EPSN0188, 64PC382, 64QD382, 452M482, EPSN0196, 451Z482, 451T482, 64PG382, 64NG382, 64PM382, EPSN0015, 64NH382, 451W482, 64PB382, 64PF382, 64NK382, 64NM382, 64NJ328, 64PK382, EPSN0239, EPSN0233, EPSN0240, EPSN0236, BPNKLJ1, 71FL6Y1, 99RX3V1, J7NLLJ1, 9DLX3V1, 999JVHW, 2FSNS81, 99CMVH1, 71HH6Y1, 28NLLJ1, 4LPL3K1, 18NLLJ1, 135GXR1, JW0QFX1, 88RHVH1, EPSN0249, EPSN0248, JW0MGX1, EPSN0252, EPSN0254, 898HVH1, JW0PFX1, EPSN0259, 13BGXR1, EPSN0272, EPSN0273, EPSN0274, 2QQM3K1, GR7LF41, EPSN0277, JPQM3K1, 1BTLPS1, 99CLVH1, JKPL3K1, 5QRWVH1, EPSN0279, EPSN0280, 897HVH1, 71XH6Y1, EPSN0282, EPSN0283, 897GVH1, EPSN0284, EPSN0285, 4T7LF41, EPSN0286, EPSN0288, EPSN0290, EPSN0292, EPSN0293, EPSN0294, 144L821, EPSN0297, EPSN0299, EPSN0298, EPSN0300, 71QJ6Y1, 9C2Y3V1, EPSN0307, 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MX241100BN, MXL2098FS, MXL6191BNO, MGO477EPI, VS81238927, 274kdz0309, EPSN0276, mj03b7wj, 493kcp0586, 1L607B1, BGHTBC, CS00556605, EPSN0447, EPSN0403, EPSN0406, EPSN0407, EPSN0278, EPSN0408, MJ57n43, EPSN0281, EPSN0287, EPSN0289, EPSN0291, EPSN0295, EPSN0296, EPSN0414, EPSN0417, EPSN0301, EPSN0302, EPSN0303, EPSN0304, EPSN0305, EPSN0306, EPSN0308, EPSN0423, EPSN0309, EPSN0312, EPSN0424, EPSN0425, EPSN0431, EPSN0432, EPSN0438, EPSN0315, EPSN0316, EPSN0317, EPSN0318, EPSN0319, EPSN0320, EPSN0326, EPSN0327, EPSN0329, EPSN0330, EPSN0339, EPSN0340, EPSN0341, EPSN0345, EPSN0347, EPSN0348, EPSN0349, EPSN0351, EPSN0353, EPSN0355, EPSN0356, 790H833, 205HPC3, 2TVSO2, 7NLZZ1, EPSN0357, MY816005GS, YLT059RF, FR6KBX, EPSN0361, EPSN0363, EPXXX3, EPSN0364, 2KZXBX, BDGG1S, 4PX222, 75DMBX, 4WPT9R2, 4WNT9R2, 4WPQ9R2, G2KXBX, 5XFZRP2, EPSN0367, EPIPX2140, EPIPX2397, MXL81515BJ, EPSN0369, MXL9364GZ8, EPSN0372, EPSN0373, EPSN0374, EPSN0375, EPSN0376, EPSN0378, EPSN0377, EPSN0379, EPSN0381, EPSN0382, EPSN0395, EPSN0396, EPSN0402, EPSN0404, EPSN0405, EPSN0409, EPSN0410, EPSN0411, EPSN0412, EPSN0415, EPSN0416, EPSN0418, 5H2SZ02, 14VV7R1, EPSN0419, EPSN0420, Verificar, 7C4Y781, EPSN0421, BZFCP41, 14Y3642, HMDSRR1, 8NNYHM1, 23VV7R1, 107712, 7FPL2V1, BRG311F3LJ, BRJ425C90J, BRG345F06F, BRJ428F1, Verificar - Service Tag, B69ZFN1, HLWMZ02, G844RF1, B844RF1, Service Tag - Verificar, Service Tag - Verificar, 7JL1ZD1, 6KL1ZD1, 7GKGD61, HLDSRR1, 1C4Y7S1, 284Y7S1, MXL7520PNB, EPSN0433, EPSN0434, EPSN0435, EPSN0436, EPSN0437, JR5002013063, JR5002013065, 3CR33002TL, FF0477EPI, MXL44609MR, JR5002015005, MXL5510RG2, MXL6191BN2, EPSN0440, MXL7411G1L, MXL6452G5N, MXL7411G4Y, MXL7191DWL, EPSN0441, MXL7281VX4, EPSN0442, EPSN0444, EPSN0446, MXL8101P8V, MXL3282GQQ, MXL33617HS, MXL307090F, MXL5500SX0, MXL4491CM1, EpiFX0046, MXL4412SFN, MXL42608HJ, 4CS42602GB, MXL5500SX1, MXL6191BM1, MXL61919RR, MXL61919RP, MXL71513R4, MXL7281VQL, MXL0013LL2, EPSN0504, MXL6450XY0, JR5002017014, MXL91125T6, JR5002017006, 8VZK613, 25YSRZ2, 25YQRZ2, MXL9222016, MXL9222031, MXL9221PD7, EPSN0393, JR5002017008, 8CG9157VJZ, 72MGCS2, DTZK613, 8CC1383WLD, 276PRZ2, 27FFBZ2, 1CZ2300668, MXL407139Z, MXL30315ZL, HP Compaq pro400, 2C2JF73, B04ZBM2, 9ZWXBM2, MXL74415HL, BCSGDH2, MXL74413VX, MXL7411GGV, MXL74413MT, EPSN0487, MXL82219X2, EPSN0488, MXL74413N3, 36SLGM2, 5MH5813, 1RPRM42, MXL7411GH5, BCSNDH2, MXL82219X7, 849DDV2, 8NCMDW2, 4MH5813, GQZG833, 2RZG833, 3NH5813, FBQ7Z03, 3PZG833, JR5002017012, 9JQSDH2, 9JQ2HH2, H218CH2, EPSN0493, EPSN0495, 5D2G5N3, 869ZFN1, 7SCDF1S, EPSN0452, EPSN0454, EPSN0455, MXL1013FVK, EPSN0457, MXL0483233, EPSN0459, EPSN0460, EPSN0461, MXL0483219, 2Z4HPC3, G9L2LK3, MP1NB7Y4, DVAHPC3, 9KM2NH3, D8L2LK3, MP249LHS, H0RJYL3, 1FLWRB3, 533136-0, 534178-0, EPSN0468, EPSN0473, 546974-0, 549552-0, B89C5D1, 1XFBMD2, 1XG5MD2, 556696-0, 122734-0, EPSN0477, 1P62N63, MXL91251FS, MXL74413VC, MXL9124BZM, 9JPWDH2, LSLE6RD, MXL82219XR, 2UA3080LCD, FBQTR22, F4Z9DZ1, 2UA318133D, 9DLXB42, HQSP842, FBQZQ22, MXL32005SF, D3B8082, JP9LJ02, 253HCP1, MXL74413ST, J7CGPS1, MXL74413R3, 46D9DH2, 2P3S5V1, 9DNZB42, 46D5DH2, F8L2LK3, GS4HPC3, 60GH1D3, 9JHPQD3, BY4HPC3, MXL82219Y2, 8Y4HPC3, 5M62KF3, 1CZ1200HNF, 1CZ1230C6D, BCSLDH2, JRL4S63, DJYB5N3, 65YB8V1, 127SQW1, PX3117EPI2, 1CZ20400G8, DFLWRB3, EPSN0513, EPSN0515, EPSN0518, EPSN0519, EPSN0521, EPSN0524, EPSN0525, EPSN0526, EPSN0527, EPSN0528, EPSN0529, EPSN0531, EPSN0537, EPSN0538, EPSN0539, EPSN0540, EPSN0542, EPSN0544, EPSN0557, EPSN0562, EPSN0565, EPSN0554, EPSN0551, EPSN0552, EPSN0553, E2PFAG0005PW, 4D4FS1S, 3KKJWBX, EPSN0556, E9PFAG000CEP, 2Z6DC1S, EPSN0571, 13GB82S, EPSN0576, EPSN0581, 4KKJWBX, F5PFAG000J06, EAPFAG0001L0, EPSN0584, JCCFS1S, EPSN0585, EPSN0593, EPSN0596, 3339X1S, 4Z6DC1S, D4PFAG000CZJ, GM27WBX, D4PFAG000ZCD, EPSN0601, 94BVB1S, 4BNWB1S, FBPFAG0002D9, MY735009LX, C3PFAG0015AU, F2PFAG0009MS, 2L2KXBX, C3PFAG0015AV, C9PFAG000TBJ, E2PFAG0005R6, MY80500G8C, FM37WBX, 6BNWB1S, E4PFAG000PUX, C4PFAG000E1X, C3PFAG0015AK, 5MQ182S, MY71200BU5, 2CYHW1S, C4PFAG000E1N, EAPFAG0001KT, C9PFAG000TBP, MY71200CCX, MY80500GUP, MY815007KV, H8K4G2S, MY715001L4, MY7350093E, 3JL46Z1, MY735009LE, MY735009JF, 3D4ZC2S, MY816005J9, MY827004W0, YE5480019G, MY8270050C, G85Z92S, E115A110402, 66NQD2S, HRDCNW1, 1D4ZC2S, 8QMYD2S, 5-04U-DEZL, 64H3G2S, 9Z8NZ1S, FVC5UTW, MXL9124BY7, H8G63N2, H8G83N2, H8GB3N2, 556707-0, G6YE548008W, H8D83N2, 532698-0, BRG311F35Y, 957HC72, 69L3QK2, 675ZPK2, MXL74413R5, MXL82219Y3, D5PHT13, H9YYQ12, J30H833, 5P62N63, 69P5TB3, MY709008J9, G6YE5020076E, YE5020075U, YE5330006M, MY827004ZT, MY82700563, 0T5FWH, 16PSWBX, 2HMVXBX, G6YE5480000P, 4FJQZZ1, 4HMVXBX, 4KJQZZ1, 54LBWBX, 66PSWBX, 6LJQZZ1, 7N3RPBX, 8FJQZZ1, 8MJQZZ1, 8ZKLJBX, CGJQZZ1, 23NS032, CQ82LY1, CR82LY1, D1XX2Y1, G6YE502007WD, F1NS032, FHJQZZ1, FKJQZZ1, GQ82LY1, HR82LY1, J450H01, JGMVXBX, EPSN0262, EPSN0263, G6YE54800001, EPSN0265, G6YE548000C4, YE5480005S, G6YE548000E6, G6YE5020079X, G6YE5020079N, JWHY032, 3YHY032, G6YE5020075K, 8WHY032, 7YHY032, 5ZHY032, B1NS032, YE502007A1, 81XX2Y1, G6YE5480016P, G6YE5020076B, G6YE548000BB, MY709008K5, 8D2G5N3, C29Y032, 623YQ52, 1L70K32, CV0YJ32, DG2BRBX, 8TVNC02, CL70K32, CSQJVBX, 9V0YJ32, 623WQ52, 624ZQ52, 3W0YJ32, 7V0YJ32, 1W0YJ32, HL70K32, 5W0YJ32, DVWRP02, 4LDZNBX, 22TS032, 65PVJ32, F3PVJ32, EPSN0022, EPSN0011, EPSN0008, EPSN0016, EPSN0085, EPSN0096, EPSN0168, EPSN0122, EPSN0067, EPSN0062, EPSN0039, EPSN0152, EPSN0114, EPSN0093, EPSN0047, EPSN0192, EPSN0102, EPSN0104, EPSN0018, EPSN0109, EPSN0075, EPSN0121, EPSN0213, EPSN0215, EPSN0024, EPSN0035, EPSN0135, EPSN0157, EPSN0100, EPSN0106, EPSN0042, EPSN0180, EPSN0186, EPSN0193, EPSN0212, H150H01, 88ZRSD2, 451Q482, 64QB382, 64PJ382, 64NL382, 64PH382, 64QC382, 452O582, 452Q482, 452V482, 64PD382, 64PL382, 451S482, 9B1W3V1, CFR07Y1, C0RD6X1, H0Z7K02, JR5002015002, 8CG927012P, 6ZRX1R1, BDB3ZQ1, 6ZPX1R1, 13NGXR1, 8GPWMS1, 6ZRV1R1, 13NHXR1, 13L9XR1, 8GQXMS1, G1Y0NS1, G7KRDC1, G200NS1, 9DN34V1, 13LFXR1, 6ZQKIR1, DLJMJS1, 13GCXR1, DLQJJS1, 9P2RDC1, 99R14V1, HFL7LF1, 8PZRDC1, D1WRDC1, H6BGJS1, JZL6QC1, 8G2BM63, G1YVMS1, 2L56SD1, 6ZNL1R1, 1BWPS1, 2YSL6D1, 1BVLPS1, 6V92BG1, C3Z5QC1, JVM91F1, 2PG06V1, CZL6QC1, 9FF24V1, 2NGX5V1, D7RXFC1, 2PBQ5V1, 2PF06V1, FL32VG1, 8YJL601, 4982BG1, 2YCF701, 99W14V1, 1BYNPS1, 5M32VG1, CNNKLJ1, AXCF701, 74Y2VG1, 5PNKLJ1, JVJHWH1, HVHJWH1, 99T04V1, FNNKLJ1, 181V5V1, 9PNKLJ1, 71PJ6Y1, 4QQM3K1, 8QQM3K1, 88THVH1, 71YK6Y1, JW0QGX1, 895FVH1, 99DJVH1, G7NLLJ1, B0GKVH1, 38NLLJ1, 88VGVH1, 88RFTVH1, 9N82V21, 895GVH1, 99BMVH1, DK15JL1, 898GVH1, B0CMVH1, 2TVSM01, 181X5V1, B0FKVH1, D50YWL1, 88YGVH1, C0RV8Y1, 2RFGWL1, CQQM3K1, 1Z6LF41, C5OYWL1, 71QK6Y1, 650YWL1, 71KK6Y1, CF217T1, 6L15JL1, CY6LF41, 7PFGWL1, FNFGW1, C9L1XL1, 363PL02, 6ZQK1R1, 831LS22, FKPQN22, FKXDN22, FL0TN22, FKYRN22, FKSGN22, FKQSN22, FL0FN22, GK15JL1, F88FN22, 4XXJS22, 4XX9S22, 82XKS22, FKWSN22, 831JS22, 834CS22, 8FJJS22, 831CS22, 6ZNX1R1, 5JXJCP1, BD21ZQ1, 30VXKM1, 4172NM1, JCB2NM1, JCB1NM1, FWCL581, JC9VKN1, 4151NM1, 30RZKM1, 30KXKM1, 30WXKM1, 753H5M1, 40Z0NM1, 7JG1M51, G5S30B1, 2M23FQ1, 9WCLS81, 5TGSCP1, OT7570, 9HG1M51, 48F2NM1, 5TGTCP1, 5THHCP1, 14DL8Z1, 71GL6Y1, 2JL7LF1, 14BL8Z1, 1FCFX12, 48D0NM1, 2NZW5V1, BGB2H41, FTFWGL1, 2YB3FQ1, BJDNS91, BGG1M51, 5JWKCP1, 9DSNS81, HDSNS81, BD73ZQ1, 3WCLS81, JVCLS81, 5CXVJQ1, 5CWWJQ1, 6ZPY1R1, H136K02, 13ZK8Z1, 13ZM8ZW, CF227Y1, 99Y34V1, H147K02, B50YWL1, 1X9FX12, 144K8Z1, H0W9K02, H0WBK02, H0Y9K02, 1XGRX12, 1FFHX12, 1XGFX12, 1XFSX12, H107K02, 66ZSX12, H168K02, H15BK02, 1F8HX12, 1FDHX12, FBDFTJ1, FDSNS81, G21ZWL1, 30NXKM1, 48P0NM1, 1XGGX12, BD24ZQ1, 2M31FQ1, BDB2H41, JBSNS81, 30JZKM1, 2M01FQ1, 30GXKM1, FYW1MN1, 450PS81, 3KDNS91, FYWNMN1, 1FFJX12, 1X8HX12, 1X8RX12, 1XDHX12, 1XCFX12, 1XDJX12, 1F8SX12, 35FML02, 1F6HX12, 34DQL02, G6YE518001HE, 35TPL02, 1F6FX12, 362TL02, 1FBHX12, 1F8FX12, 9DM14V1, 9FHV3V1, 9DG24V1, 4XYLS22, FKWRN22, 3HL7LF1, 8FHKS22, GFL7LF1, STST9215259, 34JPL02, 2PCX5V1, 82XMS22, 82ZJS22, FKSSN22, 833JS22, 832MS22, 82YJS22, FKSDN22, 830LS22, F89GN22, 4Y1BS22, FZ11MN1, MLX8101N9B, MXL8071B2D, MXL8071B3J, MXL80719X5, F6XZQN1, 2GQS7G1, 8CG8292595, 7X0TDG1, CXGLWG1, 65YLFG1, JWFSXG1, 2GC6XH1, 8CG8292529, 77GJXR1, MXL1944BXY, 9G4R0L1, B8DN1J1, 1177VH1, BHF2GD1, DKMY3G, CS700GD823, MXL71513R2, mxl6112f3p, MXL24614RR, MXL4491CM2, PX0421EPI, 1CZ20700DN, MXL4412SFL, MXL4460C76, X1553740, MXL209140R, MXL4491CM4, mj03b7tv, VS81238064. 2. Catalog Number: 441421; UDI/DI: 00382904414214; Serial Numbers: 941TSR1, 5GFG64J, FWCF15J, 60SQY4J, 2GFG64J. 3. Catalog Number: 445398; UDI/DI: 00382904453985; Serial Numbers: G6MY934003YV, G6MY84600PDX, G6MY9340042E, G6MY72900GD, G6MY93400454, G6MY9340044S, G6MY9340045Z. 4. Catalog Number: 443971; UDI/DI: 00382904439712; Serial Numbers: G6MY934003LM, G6MY934004BS, G6MY803008JK, G6MY934003J4, G6MY83700CQY, G6MY84200M2R, G6MY934003U2, G6MY737008M7, G6MY84200LBQ, G6MY93400404, G6MY934003UG, G6MY934003RT, G6MY84200LJN, G6MY737008RV, G6MY9340046H, G6MY83200GSB, G6MY83200GU4, GMY735009XK, G6MY93400499, G6MY84200LHL, G6MY9340041D, G6MY9340044L, G6MY8340011U, G6MY9340045T, G6MY8340002Q, G6MY84600NW7, G6MY84600NJQ, G6MY702005U2, G6MY72400ED3, G6MY934003K3, G6MY934003U9, G6MY934003W9, G6MY84200M4D, G6MY934003J1, G6MY9340042M, G6MY834000MV, G6MY83200GT9, G6MY71200CB3, G6MY73500965, G6MY84600P2L, G6MY934003XT, G6MY834000Z2, G6MY84600MMB, G6MY83700D0U, G6MY84600MWC, G6MY83700CQD, G6MY702006DP, G6MY80100J07, G6MY84200L6X, G6MY934003P3, G6MY934003L6, G6MY934003LV, G6MY83700DAA, G6MY84600NPS, G6MY71000NRK, G6MY84200M2U, G6MY83900C9F, G6MY80100HZ3, G6MY83200GN1, G6MY84600NY0, G6MY934003GC, G6MY83900BP5, G6MY83700CRB, G6MY83900C0F, G6MY84600N4H, G6MY83900C83, G6MY80100HSN, G6MY80100J05, G6MY934003VR, G6MY83900C8B, G6MY816005AY, G6MY83700CQL, G6MY8160057U, G6MY934004A8, G6MY84600P25, G6MY9340045V, G6MY83700CMF, G6MY702005BM, G6MY702006ET, G6MY934003QB, G6MY93400447, G6MY934003HF, G6MY83900BKB, G6MY83700DAS, G6MY84600NNE, G6MY834000JS, G6MY934003NX, G6MY72400EDV, G6MY934003GM, G6MY934003G0, G6MY834000S7, G6MY84200MAT, G6MY84200M79, G6MY84600MG9, G6MY9340040G, G6MY72400E2T, G6MY84200LJW, G6MY7020060J, G6MY8340011Q, G6MY934003KR, G6MY934003QS, G6MY934003HG, G6MY83700D1J, G6MY83900BQ9, G6MY934003RE, G6MY83900BRK, G6MY80100J2B, G6MY83200GN8, G6MY834000X5, G6MY84600MKB, G6MY934004C6, G6MY934003QA, G6MY83900BWU, G6MY84200LLG, G6MY93400424, G6MY83900BQ2, G6MY702005G3, G6MY702005DO, G6MY83200GQX, G6MY934003TM, G6MY934003Y5, G6MY9340048C, G6MY83700CRN, G6MY72400DTV, G6MY9340040B, G6MY83700CSH, G6MY735009VA, G6MY73100049, G6MY83700CQN, G6MY934003HU, G6MY84600NYV, G6MY934003S7, G6MY83700CZ0, G6MY7350098V, G6MY934003SQ, G6MY83700DCA, G6MY72400DPP, G6MY735009JC, G6MY84200L73, G6MY934003GY, G6MY84600MJW, G6MY934003FT, G6MY83900BQC, G6MY934003ZD, G6MY934003KK, G6MY83700CWA, G6MY729000V7, G6MY735009CX, G6MY934003UZ, G6MY934003V6, G6MY934003UT, G6MY934003TS, G6MY83900C7T, G6MY815007ZN, G6MY934003U3, G6MY83700D3R, G6MY84200LEH, G6MY8160056K, G6MY815007ZT, G6MY934003TZ, G6MY934004BR, G6MY84200LBL, G6MY83700CPW, G6MY834000ZC, G6MY934004BB, G6MY83700D9W, G6MY934004D2, G6MY816005F2, G6MY83700CM9, G6MY9340049A, G6MY934003HC, G6MY93400446, G6MY84200LU6, G6MY83700CK0, G6MY84600NLK, G6MY83900C60, G6MY84200MDD, G6MY934004BT, G6MY934003WR, G6MY934004CL, G6MY934003Q1, G6MY9340042K, G6MY84600P9S, G6MY83700DA5, G6MY934003J5, G6MY84600P1T, G6MY934003P2, G6MY83900BLP, G6MY83900C8E, G6MY9340044C, G6MY934003TU, G6MY934003W7, G6MY735009ZP, G6MY83700DAZ, G6MY934003TR, G6MY83700D2S, G6MY934003P6, G6MY83900BHL, G6MY83700CQP, G6MY83700CS5, G6MY83900BHX, G6MY83700CUG, G6MY83700CQ1, G6MY83700D6E, G6MY934003VT, G6MY84200LL8, G6MY84200LJT, G6MY934003HS, G6MY84200LE9, G6MY84200MPB, G6MY934003VZ.
Where was it sold?
Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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