--- title: "Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only — FDA record Z-0912-2026 | Is It on Recall" description: "Screw may loosen or fallout of Hemodialysis system" url: https://isitonrecall.com/recall/fda-device-z-0912-2026-hemodialysis-system-surdial-dx-ref-mc-sdx01-rx-only/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only — FDA record Z-0912-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only - **Reason**: Screw may loosen or fallout of Hemodialysis system - **Classification**: Class II - **Recalling firm**: Nipro Medical Corporation - **Quantity**: N/A - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0912-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0912-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI: 00383790008815/Serial Numbers: 20EW0001 20EW0002 20EW0005 20EW0006 20EW0007 20EW0008 20EW0009 20EW0010 20EW0011 20EW0012 20EW0013 20EW0014 20EW0015 20EW0016 20EW0017 20EW0018 20EW0019 20EW0020 20EW0021 20EW0022 20EW0023 20EW0024 20EW0025 20EW0026 20EW0027 20EW0028 20EW0029 20EW0030 20EW0031 20EW0032 20EW0033 20EW0034 20EW0035 20EW0036 20EW0037 20EW0038 20EW0039 20EW0040 20EW0041 20EW0042 20EW0043 20EW0044 20EW0045 20EW0046 20EW0048 20EW0049 20EW0050 21EW0061 21EW0062 21EW0063 21EW0064 21EW0065 21EW0066 21EW0067 21EW0068 21EW0069 21EW0070 21EW0071 21EW0072 21EW0073 21EW0075 21EW0076 21EW0077 21EW0078 21EW0079 21EW0080 21EW0081 21EW0082 21EW0083 21EW0084 21EW0085 21EW0086 21EW0087 21EW0088 21EW0089 21EW0090 21EW0091 21EW0092 21EW0093 21EW0094 21EW0095 21EW0096 21EW0097 21EW0098 21EW0099 21EW0100 21EW0101 21EW0102 21EW0103 21EW0104 21EW0105 21EW0106 21EW0107 21EW0108 21EW0109 21EW0110 21EW0111 21EW0112 21EW0113 21EW0114 21EW0115 21EW0116 21EW0117 21EW0118 21EW0119 21EW0120 21EW0122 21EW0123 21EW0124 21EW0125 21EW0126 21EW0127 21EW0128 21EW0129 21EW0130 21EW0131 21EW0133 21EW0134 21EW0135 21EW0136 21EW0137 21EW0138 21EW0139 21EW0140 21EW0141 21EW0142 21EW0143 21EW0144 21EW0145 21EW0146 21EW0147 21EW0148 21EW0149 21EW0150 21EW0151 21EW0152 21EW0153 21EW0154 21EW0155 21EW0156 21EW0157 21EW0158 21EW0159 21EW0160 21EW0162 21EW0163 21EW0164 21EW0165 21EW0166 21EW0167 21EW0168 21EW0169 21EW0170 21EW0171 21EW0172 21EW0173 21EW0174 21EW0175 21EW0176 21EW0177 21EW0178 21EW0179 21EW0180 21EW0181 21EW0182 21EW0183 21EW0184 21EW0185 21EW0186 21EW0187 21EW0188 21EW0189 21EW0190 21EW0191 21EW0192 21EW0193 21EW0194 21EW0195 21EW0196 21EW0197 21EW0198 21EW0199 21EW0200 21EW0201 21EW0202 21EW0203 21EW0204 21EW0205 21EW0206 21EW0207 21EW0208 21EW0209 21EW0210 21EW0211 21EW0212 21EW0213 21EW0214 21EW0215 21EW0216 21EW0217 21EW0218 21EW0219 21EW0220 21EW0221 21EW0222 21EW0223 21EW0224 21EW0225 21EW0226 21EW0227 21EW0228 21EW0229 21EW0230 21EW0231 21EW0232 21EW0233 21EW0234 21EW0235 21EW0236 21EW0237 21EW0238 21EW0239 21EW0240 21EW0241 21EW0242 21EW0243 21EW0244 21EW0245 21EW0246 21EW0247 21EW0248 21EW0249 21EW0250 21EW0251 21EW0252 21EW0253 21EW0254 21EW0255 21EW0256 21EW0257 21EW0258 21EW0259 21EW0260 21EW0261 21EW0262 21EW0264 21EW0265 21EW0266 21EW0267 21EW0268 21EW0269 21EW0270 21EW0271 21EW0272 21EW0273 21EW0274 21EW0275 21EW0276 21EW0277 21EW0278 21EW0279 21EW0280 21EW0281 21EW0282 21EW0283 21EW0284 21EW0285 21EW0286 22EW0287 22EW0288 22EW0289 22EW0290 22EW0291 22EW0292 22EW0293 22EW0294 22EW0295 22EW0296 22EW0297 22EW0298 22EW0299 22EW0300 22EW0301 22EW0302 22EW0303 22EW0304 22EW0305 22EW0306 22EW0307 22EW0308 22EW0309 22EW0310 22EW0311 22EW0312 22EW0313 22EW0314 22EW0315 22EW0316 22EW0317 22EW0318 22EW0319 22EW0320 22EW0321 22EW0322 22EW0323 22EW0324 22EW0325 22EW0326 22EW0327 22EW0328 22EW0329 22EW0330 22EW0331 22EW0332 22EW0333 22EW0334 22EW0335 22EW0336 22EW0337 22EW0338 22EW0339 22EW0340 22EW0341 22EW0342 22EW0343 22EW0344 22EW0345 22EW0346 22EW0347 22EW0348 22EW0351 22EW0352 22EW0353 22EW0354 22EW0355 22EW0356 22EW0357 22EW0358 22EW0359 22EW0360 23EW0361 23EW0362 23EW0363 23EW0364 23EW0365 23EW0366 23EW0367 23EW0368 23EW0369 23EW0370 23EW0371 23EW0372 23EW0373 23EW0374 23EW0375 23EW0376 23EW0377 23EW0378 23EW0379 23EW0380 23EW0381 23EW0382 23EW0383 23EW0384 23EW0385 23EW0386 23EW0387 23EW0388 23EW0389 23EW0390 23EW0391 23EW0392 23EW0393 23EW0394 23EW0395 23EW0396 23EW0397 23EW0398 23EW0399 23EW0400 23EW0401 23EW0402 23EW0403 23EW0404 23EW0405 23EW0406 23EW0407 23EW0408 23EW0409 23EW0410 23EW0411 23EW0412 23EW0413 23EW0414 23EW0415 23EW0416 23EW0417 23EW0418 23EW0419 23EW0420 23EW0421 23EW0422 23EW0423 23EW0424 23EW0425 23EW0426 23EW0427 23EW0428 23EW0429 23EW0430 23EW0431 23EW0432 23EW0433 23EW0434 23EW0435 23EW0436 23EW0437 23EW0438 23EW0439 23EW0440 23EW0441 23EW0442 23EW0443 23EW0444 23EW0445 23EW0446 23EW0447 23EW0448 23EW0449 23EW0450 23EW0451 23EW0452 23EW0453 23EW0454 23EW0455 23EW0456 23EW0457 23EW0458 23EW0459 23EW0460 23EW0461 23EW0462 23EW0463 23EW0464 23EW0465 23EW0466 23EW0467 23EW0468 23EW0469 23EW0470 23EW0471 23EW0472 23EW0473 23EW0474 23EW0475 23EW0476 23EW0477 23EW0478 23EW0479 23EW0480 23EW0481 23EW0482 23EW0483 23EW0484 23EW0485 23EW0486 23EW0487 23EW0488 23EW0489 23EW0490 23EW0491 23EW0492 23EW0493 23EW0495 23EW0496 23EW0497 23EW0498 23EW0499 23EW0500 23EW0501 23EW0502 23EW0503 23EW0504 23EW0505 23EW0506 23EW0507 23EW0508 23EW0509 23EW0510 23EW0511 23EW0512 23EW0513 23EW0514 23EW0515 23EW0516 23EW0517 23EW0518 23EW0519 23EW0520 23EW0521 23EW0522 23EW0523 23EW0524 23EW0525 23EW0526 23EW0527 23EW0528 23EW0529 23EW0530 23EW0531 23EW0532 23EW0533 23EW0534 23EW0535 23EW0536 23EW0537 23EW0538 23EW0539 23EW0540 24EW0004 24EW0541 24EW0542 24EW0543 24EW0544 24EW0545 24EW0546 24EW0547 24EW0548 24EW0549 24EW0550 24EW0551 24EW0552 24EW0553 24EW0554 24EW0555 24EW0556 24EW0557 24EW0558 24EW0559 24EW0560 24EW0561 24EW0562 24EW0563 24EW0564 24EW0565 24EW0566 24EW0567 24EW0568 24EW0569 24EW0570 24EW0571 24EW0572 24EW0573 24EW0574 24EW0575 24EW0576 24EW0577 24EW0578 24EW0579 24EW0580 24EW0581 24EW0582 24EW0583 24EW0584 24EW0585 24EW0586 24EW0587 24EW0588 24EW0589 24EW0590 24EW0591 24EW0592 24EW0593 24EW0594 24EW0595 24EW0596 24EW0597 24EW0598 24EW0599 24EW0600 24EW0601 24EW0602 24EW0603 24EW0604 24EW0605 24EW0606 24EW0607 24EW0608 24EW0609 24EW0610 24EW0611 24EW0612 24EW0613 24EW0614 24EW0615 24EW0616 24EW0617 24EW0618 24EW0619 24EW0620 24EW0621 24EW0622 24EW0623 24EW0624 24EW0625 24EW0626 24EW0627 24EW0628 24EW0629 24EW0630 24EW0631 24EW0632 24EW0633 24EW0634 24EW0635 24EW0636 24EW0637 24EW0638 24EW0639 24EW0640 24EW0641 24EW0642 24EW0643 24EW0644 24EW0645 24EW0646 24EW0647 24EW0648 24EW0649 24EW0650 24EW0651 24EW0652 24EW0653 24EW0654 24EW0655 24EW0656 24EW0657 24EW0658 24EW0659 24EW0660 24EW0661 24EW0662 24EW0663 24EW0664 24EW0665 24EW0666 24EW0667 24EW0668 24EW0669 24EW0670 24EW0671 24EW0672 24EW0673 24EW0674 24EW0675 24EW0676 24EW0677 24EW0678 24EW0679 24EW0680 24EW0681 24EW0682 24EW0683 24EW0684 24EW0685 24EW0686 24EW0687 24EW0688 24EW0689 24EW0690 24EW0691 24EW0692 24EW0693 24EW0694 24EW0695 24EW0696 24EW0697 24EW0698 24EW0699 24EW0700 24EW0701 24EW0702 24EW0703 24EW0704 24EW0705 24EW0706 24EW0707 24EW0708 24EW0709 24EW0710 24EW0711 24EW0712 24EW0713 24EW0714 24EW0715 24EW0716 24EW0717 24EW0718 24EW0719 24EW0720 24EW0721 24EW0722 24EW0723 24EW0724 24EW0725 24EW0726 24EW0727 24EW0728 24EW0729 24EW0730 24EW0731 24EW0732 24EW0733 24EW0734 24EW0735 24EW0736 24EW0737 24EW0738 24EW0739 24EW0740 24EW0741 24EW0742 24EW0743 24EW0744 24EW0745 24EW0746 24EW0747 24EW0748 24EW0749 24EW0750 24EW0751 24EW0752 24EW0753 24EW0754 24EW0755 24EW0756 24EW0757 24EW0758 24EW0759 24EW0760 24EW0761 24EW0762 24EW0763 24EW0764 24EW0765 24EW0766 24EW0767 24EW0768 24EW0769 24EW0770 24EW0771 24EW0772 24EW0773 24EW0774 24EW0775 24EW0776 24EW0777 24EW0778 24EW0779 24EW0780 24EW0781 24EW0782 24EW0783 24EW0784 24EW0785 24EW0786 24EW0787 24EW0788 24EW0789 24EW0790 24EW0791 24EW0792 24EW0793 24EW0794 24EW0795 24EW0796 24EW0797 24EW0798 24EW0799 24EW0800 24EW0801 24EW0802 24EW0803 24EW0804 24EW0805 24EW0806 24EW0807 24EW0808 24EW0809 24EW0810 24EW0811 24EW0812 24EW0813 24EW0814 24EW0815 24EW0816 24EW0817 24EW0818 24EW0819 24EW0820 24EW0821 24EW0822 24EW0823 24EW0824 24EW0825 24EW0826 24EW0827 24EW0828 24EW0829 24EW0830 24EW0831 24EW0832 24EW0833 24EW0834 24EW0835 24EW0836 24EW0837 24EW0838 24EW0839 24EW0840 24EW0841 24EW0842 24EW0843 24EW0844 24EW0845 24EW0846 24EW0847 24EW0848 24EW0849 24EW0850 24EW0851 24EW0852 24EW0853 24EW0854 24EW0855 24EW0856 24EW0857 24EW0858 24EW0859 24EW0860 24EW0861 24EW0862 24EW0863 24EW0864 24EW0865 24EW0866 24EW0867 24EW0868 24EW0869 24EW0870 24EW0871 24EW0872 24EW0873 24EW0874 24EW0875 24EW0876 24EW0877 24EW0878 24EW0879 24EW0880 24EW0881 24EW0882 24EW0883 24EW0884 24EW0885 24EW0886 24EW0887 24EW0888 24EW0889 24EW0890 24EW0891 24EW0892 24EW0893 24EW0894 24EW0895 24EW0896 24EW0897 24EW0898 24EW0899 24EW0900 24EW0901 24EW0902 24EW0903 24EW0904 24EW0905 24EW0906 24EW0907 24EW0908 24EW0909 24EW0910 24EW0911 24EW0912 24EW0913 24EW0914 24EW0915 24EW0916 24EW0917 24EW0918 24EW0919 24EW0920 24EW0921 24EW0922 24EW0923 24EW0924 24EW0925 24EW0926 24EW0927 24EW0928 24EW0929 24EW0930 24EW0931 24EW0932 24EW0933 24EW0934 24EW0935 24EW0936 24EW0937 24EW0938 24EW0939 24EW0940 24EW0941 24EW0942 24EW0943 24EW0944 24EW0945 24EW0946 24EW0947 24EW0948 24EW0949 24EW0950 24EW0951 24EW0952 24EW0953 24EW0954 24EW0955 24EW0956 24EW0957 24EW0958 24EW0959 24EW0960 24EW0961 24EW0962 24EW0963 24EW0964 24EW0965 24EW0966 24EW0967 24EW0968 24EW0969 24EW0970 24EW0971 24EW0972 24EW0973 24EW0974 24EW0975 24EW0976 24EW0977 24EW0978 24EW0979 24EW0980 24EW0981 24EW0982 24EW0983 24EW0984 24EW0985 24EW0986 24EW0987 24EW0988 24EW0989 24EW0990 24EW0991 24EW0992 24EW0993 24EW0994 24EW0995 24EW0996 24EW0997 24EW0998 24EW0999 24EW1000 24EW1001 24EW1002 24EW1003 24EW1004 24EW1005 24EW1006 24EW1007 24EW1008 24EW1009 24EW1010 24EW1011 24EW1012 24EW1013 24EW1014 24EW1015 24EW1016 24EW1017 24EW1018 24EW1019 24EW1020 24EW1021 24EW1022 24EW1023 24EW1024 24EW1026 24EW1027 24EW1028 24EW1029 24EW1030 24EW1031 24EW1032 24EW1033 24EW1034 24EW1035 24EW1036 24EW1037 24EW1038 24EW1039 24EW1040 24EW1041 24EW1042 24EW1043 24EW1044 24EW1045 24EW1046 24EW1047 24EW1048 24EW1050 24EW1051 24EW1052 24EW1053 24EW1054 24EW1055 24EW1056 24EW1057 24EW1058 24EW1059 24EW1060 24EW1061 24EW1062 24EW1063 24EW1064 24EW1065 24EW1066 24EW1067 24EW1068 24EW1069 24EW1070 24EW1071 24EW1072 24EW1073 24EW1074 24EW1075 24EW1076 24EW1077 24EW1078 24EW1079 24EW1080 24EW1081 24EW1082 24EW1083 24EW1084 24EW1085 24EW1086 24EW1087 24EW1088 24EW1089 24EW1090 24EW1091 24EW1092 24EW1093 24EW1094 24EW1095 24EW1096 24EW1097 24EW1098 24EW1099 24EW1100 24EW1101 24EW1102 24EW1103 24EW1104 24EW1105 24EW1106 24EW1107 24EW1108 24EW1109 24EW1110 24EW1111 24EW1112 24EW1113 24EW1114 24EW1115 24EW1116 24EW1117 24EW1118 24EW1119 24EW1120 24EW1121 24EW1122 24EW1123 24EW1124 24EW1125 24EW1126 24EW1127 24EW1128 24EW1129 24EW1130 24EW1131 24EW1132 24EW1133 24EW1134 24EW1135 24EW1136 24EW1137 24EW1138 24EW1139 24EW1140 24EW1141 24EW1142 24EW1143 24EW1144 24EW1145 24EW1146 24EW1147 24EW1148 24EW1149 24EW1150 24EW1151 24EW1152 24EW1153 24EW1154 24EW1155 24EW1156 24EW1157 24EW1158 24EW1159 24EW1160 24EW1161 24EW1162 24EW1163 24EW1164 24EW1165 24EW1166 24EW1167 24EW1168 24EW1169 24EW1170 24EW1171 24EW1172 24EW1173 24EW1174 24EW1175 24EW1176 24EW1177 24EW1178 24EW1179 24EW1180 24EW1181 24EW1182 24EW1183 24EW1184 24EW1186 24EW1187 24EW1188 24EW1189 24EW1190 24EW1191 24EW1192 24EW1193 24EW1194 24EW1195 24EW1196 24EW1197 24EW1198 24EW1199 24EW1200 24EW1201 24EW1202 24EW1203 24EW1204 24EW1205 24EW1206 24EW1207 24EW1208 24EW1209 24EW1210 24EW1211 24EW1212 24EW1213 24EW1214 24EW1215 24EW1216 24EW1217 24EW1218 24EW1219 24EW1220 24EW1221 24EW1222 24EW1223 24EW1224 24EW1225 24EW1226 24EW1228 24EW1229 24EW1230 24EW1231 24EW1232 24EW1233 24EW1234 24EW1235 24EW1236 24EW1237 24EW1238 24EW1239 24EW1240 24EW1241 24EW1242 24EW1243 24EW1244 24EW1245 24EW1246 24EW1247 24EW1248 24EW1249 24EW1250 24EW1251 24EW1252 24EW1253 24EW1254 24EW1255 24EW1256 24EW1257 24EW1258 24EW1259 24EW1260 24EW1261 24EW1262 24EW1263 24EW1264 24EW1265 24EW1266 24EW1267 24EW1268 24EW1269 24EW1270 24EW1271 24EW1272 24EW1273 24EW1274 24EW1275 24EW1276 24EW1277 24EW1278 24EW1279 24EW1280 24EW1281 24EW1282 24EW1283 24EW1284 24EW1285 24EW1286 24EW1287 24EW1288 24EW1289 24EW1290 24EW1291 24EW1292 24EW1293 24EW1294 24EW1295 24EW1296 24EW1297 24EW1298 24EW1299 24EW1300 24EW1301 24EW1302 24EW1303 24EW1304 24EW1305 24EW1306 24EW1307 24EW1308 24EW1309 24EW1310 24EW1311 24EW1312 24EW1313 24EW1314 24EW1315 24EW1316 24EW1317 24EW1318 24EW1319 24EW1320 24EW1321 24EW1322 24EW1323 24EW1324 24EW1325 24EW1326 24EW1327 24EW1328 24EW1329 24EW1330 24EW1331 24EW1332 24EW1333 24EW1334 24EW1335 24EW1336 24EW1337 24EW1338 24EW1339 24EW1340 24EW1341 24EW1342 24EW1343 24EW1344 24EW1345 24EW1346 24EW1347 24EW1348 24EW1349 24EW1350 24EW1351 24EW1352 24EW1353 ... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0912-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IA, MI, MN, MS, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TX, WV, WC. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Dec 17, 2025 - **Recall initiation date**: Oct 27, 2025 - **Center classification date**: Dec 11, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0912-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Nipro Medical Corporation records](https://isitonrecall.com/brand/nipro-medical-corporation/)