--- title: "Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 — FDA record Z-0961-2026 | Is It on Recall" description: "Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is pot" url: https://isitonrecall.com/recall/fda-device-z-0961-2026-alinity-ci-series-system-control-module-scm-ref-03r70-01-03r70-20/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 — FDA record Z-0961-2026 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 Nov 13, 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**: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 - **Reason**: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations. - **Classification**: Class II - **Recalling firm**: Abbott Laboratories - **Quantity**: 11653 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0961-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0961-2026%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-DI: 00380740137410. GTIN: 06952999490048. Software versions 3.6.1 and lower. Serial Numbers: SCM01010 SCM01012 SCM01016 SCM01035 SCM01043 SCM01051 SCM01063 SCM01069 SCM01075 SCM01076 SCM01078 SCM01082 SCM01085 SCM01086 SCM01087 SCM01088 SCM01092 SCM01093 SCM01094 SCM01095 SCM01098 SCM01099 SCM01101 SCM01102 SCM01106 SCM01107 SCM01110 SCM01115 SCM01116 SCM01120 SCM01121 SCM01122 SCM01123 SCM01124 SCM01126 SCM01127 SCM01128 SCM01129 SCM01132 SCM01134 SCM01135 SCM01136 SCM01137 SCM01138 SCM01142 SCM01143 SCM01149 SCM01150 SCM01151 SCM01154 SCM01163 SCM01166 SCM01170 SCM01171 SCM01172 SCM01174 SCM01175 SCM01176 SCM01179 SCM01180 SCM01181 SCM01184 SCM01192 SCM01193 SCM01194 SCM01196 SCM01197 SCM01198 SCM01199 SCM01200 SCM01201 SCM01203 SCM01204 SCM01205 SCM01207 SCM01211 SCM01213 SCM01216 SCM01217 SCM01219 SCM01220 SCM01221 SCM01222 SCM01223 SCM01224 SCM01225 SCM01226 SCM01229 SCM01230 SCM01232 SCM01236 SCM01237 SCM01238 SCM01239 SCM01240 SCM01244 SCM01247 SCM01249 SCM01251 SCM01252 SCM01253 SCM01254 SCM01255 SCM01256 SCM01257 SCM01258 SCM01267 SCM01268 SCM01269 SCM01270 SCM01271 SCM01273 SCM01274 SCM01277 SCM01279 SCM01281 SCM01282 SCM01283 SCM01284 SCM01286 SCM01289 SCM01290 SCM01291 SCM01293 SCM01294 SCM01297 SCM01298 SCM01300 SCM01301 SCM01302 SCM01305 SCM01306 SCM01307 SCM01308 SCM01310 SCM01312 SCM01313 SCM01314 SCM01315 SCM01316 SCM01317 SCM01320 SCM01321 SCM01323 SCM01326 SCM01328 SCM01333 SCM01334 SCM01335 SCM01336 SCM01337 SCM01338 SCM01339 SCM01340 SCM01341 SCM01342 SCM01343 SCM01344 SCM01345 SCM01346 SCM01348 SCM01349 SCM01350 SCM01354 SCM01355 SCM01356 SCM01357 SCM01361 SCM01362 SCM01365 SCM01368 SCM01370 SCM01371 SCM01372 SCM01373 SCM01374 SCM01375 SCM01376 SCM01377 SCM01378 SCM01379 SCM01380 SCM01381 SCM01382 SCM01383 SCM01385 SCM01386 SCM01387 SCM01388 SCM01389 SCM01393 SCM01394 SCM01395 SCM01396 SCM01397 SCM01399 SCM01401 SCM01402 SCM01403 SCM01404 SCM01405 SCM01406 SCM01407 SCM01408 SCM01409 SCM01411 SCM01412 SCM01414 SCM01415 SCM01416 SCM01417 SCM01418 SCM01421 SCM01422 SCM01423 SCM01424 SCM01425 SCM01429 SCM01430 SCM01431 SCM01432 SCM01433 SCM01434 SCM01437 SCM01438 SCM01439 SCM01440 SCM01442 SCM01443 SCM01444 SCM01445 SCM01446 SCM01447 SCM01448 SCM01449 SCM01450 SCM01451 SCM01452 SCM01453 SCM01454 SCM01455 SCM01456 SCM01457 SCM01458 SCM01460 SCM01461 SCM01462 SCM01465 SCM01466 SCM01467 SCM01468 SCM01469 SCM01470 SCM01471 SCM01473 SCM01474 SCM01475 SCM01476 SCM01478 SCM01479 SCM01480 SCM01481 SCM01483 SCM01485 SCM01486 SCM01487 SCM01489 SCM01491 SCM01492 SCM01493 SCM01494 SCM01495 SCM01496 SCM01497 SCM01499 SCM01501 SCM01503 SCM01504 SCM01505 SCM01506 SCM01508 SCM01511 SCM01512 SCM01513 SCM01515 SCM01517 SCM01518 SCM01519 SCM01524 SCM01525 SCM01526 SCM01527 SCM01528 SCM01529 SCM01530 SCM01531 SCM01532 SCM01534 SCM01535 SCM01536 SCM01539 SCM01540 SCM01542 SCM01544 SCM01545 SCM01547 SCM01548 SCM01553 SCM01556 SCM01557 SCM01558 SCM01560 SCM01561 SCM01562 SCM01563 SCM01564 SCM01566 SCM01567 SCM01568 SCM01569 SCM01570 SCM01571 SCM01572 SCM01575 SCM01576 SCM01577 SCM01579 SCM01580 SCM01581 SCM01582 SCM01584 SCM01586 SCM01587 SCM01588 SCM01589 SCM01593 SCM01594 SCM01595 SCM01597 SCM01598 SCM01599 SCM01600 SCM01601 SCM01602 SCM01603 SCM01604 SCM01605 SCM01607 SCM01608 SCM01609 SCM01610 SCM01611 SCM01613 SCM01615 SCM01616 SCM01617 SCM01618 SCM01619 SCM01620 SCM01622 SCM01623 SCM01624 SCM01625 SCM01627 SCM01630 SCM01631 SCM01632 SCM01633 SCM01634 SCM01635 SCM01636 SCM01638 SCM01641 SCM01642 SCM01645 SCM01647 SCM01648 SCM01649 SCM01650 SCM01651 SCM01652 SCM01654 SCM01655 SCM01657 SCM01659 SCM01660 SCM01661 SCM01662 SCM01665 SCM01666 SCM01668 SCM01669 SCM01670 SCM01678 SCM01680 SCM01681 SCM01682 SCM01683 SCM01684 SCM01686 SCM01687 SCM01688 SCM01689 SCM01690 SCM01693 SCM01697 SCM01698 SCM01699 SCM01700 SCM01701 SCM01704 SCM01705 SCM01707 SCM01708 SCM01709 SCM01711 SCM01712 SCM01714 SCM01715 SCM01716 SCM01717 SCM01718 SCM01719 SCM01720 SCM01721 SCM01722 SCM01725 SCM01728 SCM01729 SCM01730 SCM01731 SCM01732 SCM01733 SCM01734 SCM01735 SCM01738 SCM01739 SCM01740 SCM01741 SCM01744 SCM01749 SCM01750 SCM01751 SCM01752 SCM01753 SCM01754 SCM01755 SCM01756 SCM01757 SCM01758 SCM01759 SCM01760 SCM01761 SCM01762 SCM01763 SCM01764 SCM01765 SCM01767 SCM01768 SCM01770 SCM01772 SCM01773 SCM01776 SCM01778 SCM01779 SCM01780 SCM01781 SCM01782 SCM01783 SCM01784 SCM01785 SCM01786 SCM01787 SCM01788 SCM01789 SCM01790 SCM01791 SCM01792 SCM01794 SCM01795 SCM01797 SCM01798 SCM01799 SCM01800 SCM01802 SCM01803 SCM01806 SCM01807 SCM01808 SCM01809 SCM01810 SCM01811 SCM01812 SCM01813 SCM01814 SCM01815 SCM01816 SCM01817 SCM01818 SCM01819 SCM01820 SCM01821 SCM01822 SCM01823 SCM01824 SCM01825 SCM01826 SCM01827 SCM01828 SCM01829 SCM01830 SCM01831 SCM01832 SCM01833 SCM01835 SCM01838 SCM01840 SCM01842 SCM01843 SCM01844 SCM01845 SCM01846 SCM01848 SCM01849 SCM01851 SCM01852 SCM01856 SCM01857 SCM01858 SCM01859 SCM01860 SCM01862 SCM01866 SCM01867 SCM01868 SCM01869 SCM01870 SCM01871 SCM01872 SCM01873 SCM01874 SCM01877 SCM01878 SCM01879 SCM01880 SCM01881 SCM01882 SCM01883 SCM01884 SCM01886 SCM01887 SCM01888 SCM01889 SCM01890 SCM01891 SCM01892 SCM01893 SCM01894 SCM01895 SCM01897 SCM01898 SCM01899 SCM01900 SCM01901 SCM01902 SCM01903 SCM01904 SCM01905 SCM01906 SCM01907 SCM01908 SCM01910 SCM01911 SCM01913 SCM01915 SCM01916 SCM01917 SCM01919 SCM01920 SCM01922 SCM01923 SCM01924 SCM01925 SCM01926 SCM01927 SCM01928 SCM01929 SCM01931 SCM01934 SCM01935 SCM01936 SCM01937 SCM01938 SCM01940 SCM01941 SCM01942 SCM01943 SCM01944 SCM01945 SCM01946 SCM01947 SCM01948 SCM01950 SCM01951 SCM01952 SCM01953 SCM01954 SCM01955 SCM01956 SCM01957 SCM01958 SCM01959 SCM01960 SCM01961 SCM01963 SCM01964 SCM01965 SCM01966 SCM01969 SCM01970 SCM01975 SCM01976 SCM01977 SCM01985 SCM01986 SCM01987 SCM01988 SCM01989 SCM01990 SCM01992 SCM01993 SCM01994 SCM01995 SCM01996 SCM01997 SCM01998 SCM01999 SCM02000 SCM02001 SCM02002 SCM02003 SCM02005 SCM02006 SCM02008 SCM02009 SCM02010 SCM02011 SCM02012 SCM02013 SCM02014 SCM02015 SCM02016 SCM02017 SCM02018 SCM02019 SCM02020 SCM02021 SCM02022 SCM02023 SCM02024 SCM02025 SCM02027 SCM02028 SCM02030 SCM02031 SCM02032 SCM02033 SCM02034 SCM02035 SCM02037 SCM02038 SCM02041 SCM02042 SCM02043 SCM02044 SCM02045 SCM02046 SCM02047 SCM02048 SCM02049 SCM02050 SCM02051 SCM02052 SCM02053 SCM02054 SCM02055 SCM02056 SCM02058 SCM02060 SCM02065 SCM02068 SCM02069 SCM02070 SCM02071 SCM02075 SCM02077 SCM02078 SCM02079 SCM02080 SCM02081 SCM02083 SCM02084 SCM02085 SCM02086 SCM02088 SCM02089 SCM02090 SCM02092 SCM02093 SCM02094 SCM02095 SCM02096 SCM02098 SCM02099 SCM02100 SCM02101 SCM02102 SCM02103 SCM02104 SCM02105 SCM02106 SCM02107 SCM02108 SCM02109 SCM02110 SCM02111 SCM02116 SCM02118 SCM02119 SCM02120 SCM02121 SCM02122 SCM02123 SCM02124 SCM02127 SCM02128 SCM02129 SCM02130 SCM02131 SCM02132 SCM02133 SCM02134 SCM02135 SCM02136 SCM02138 SCM02139 SCM02140 SCM02141 SCM02142 SCM02143 SCM02144 SCM02145 SCM02147 SCM02148 SCM02151 SCM02153 SCM02156 SCM02158 SCM02160 SCM02161 SCM02162 SCM02163 SCM02164 SCM02165 SCM02166 SCM02173 SCM02174 SCM02175 SCM02178 SCM02179 SCM02180 SCM02181 SCM02183 SCM02185 SCM02186 SCM02187 SCM02188 SCM02189 SCM02192 SCM02193 SCM02194 SCM02195 SCM02196 SCM02197 SCM02200 SCM02201 SCM02202 SCM02203 SCM02204 SCM02205 SCM02207 SCM02208 SCM02209 SCM02210 SCM02211 SCM02215 SCM02216 SCM02217 SCM02218 SCM02220 SCM02221 SCM02222 SCM02223 SCM02224 SCM02226 SCM02228 SCM02229 SCM02230 SCM02231 SCM02232 SCM02233 SCM02234 SCM02235 SCM02236 SCM02237 SCM02238 SCM02239 SCM02240 SCM02241 SCM02242 SCM02243 SCM02245 SCM02246 SCM02247 SCM02248 SCM02251 SCM02252 SCM02253 SCM02254 SCM02255 SCM02256 SCM02257 SCM02258 SCM02259 SCM02260 SCM02261 SCM02264 SCM02266 SCM02267 SCM02268 SCM02270 SCM02271 SCM02272 SCM02274 SCM02276 SCM02277 SCM02278 SCM02279 SCM02280 SCM02281 SCM02282 SCM02283 SCM02284 SCM02285 SCM02286 SCM02288 SCM02294 SCM02295 SCM02296 SCM02297 SCM02298 SCM02300 SCM02301 SCM02302 SCM02303 SCM02305 SCM02306 SCM02307 SCM02308 SCM02309 SCM02310 SCM02311 SCM02312 SCM02313 SCM02314 SCM02315 SCM02316 SCM02317 SCM02318 SCM02319 SCM02320 SCM02321 SCM02322 SCM02323 SCM02324 SCM02325 SCM02326 SCM02327 SCM02328 SCM02331 SCM02332 SCM02333 SCM02334 SCM02335 SCM02336 SCM02337 SCM02339 SCM02341 SCM02344 SCM02347 SCM02348 SCM02349 SCM02350 SCM02351 SCM02356 SCM02358 SCM02359 SCM02363 SCM02364 SCM02365 SCM02366 SCM02367 SCM02369 SCM02370 SCM02372 SCM02373 SCM02374 SCM02375 SCM02377 SCM02378 SCM02379 SCM02380 SCM02381 SCM02382 SCM02383 SCM02384 SCM02385 SCM02386 SCM02388 SCM02389 SCM02390 SCM02391 SCM02392 SCM02393 SCM02395 SCM02396 SCM02398 SCM02399 SCM02400 SCM02401 SCM02402 SCM02404 SCM02405 SCM02406 SCM02407 SCM02409 SCM02411 SCM02413 SCM02415 SCM02416 SCM02417 SCM02418 SCM02419 SCM02421 SCM02422 SCM02423 SCM02424 SCM02426 SCM02427 SCM02428 SCM02429 SCM02431 SCM02432 SCM02438 SCM02439 SCM02443 SCM02450 SCM02454 SCM02455 SCM02456 SCM02462 SCM02466 SCM02467 SCM02471 SCM02472 SCM02473 SCM02474 SCM02475 SCM02476 SCM02477 SCM02478 SCM02479 SCM02480 SCM02481 SCM02482 SCM02483 SCM02484 SCM02485 SCM02486 SCM02489 SCM02490 SCM02493 SCM02497 SCM02498 SCM02499 SCM02500 SCM02501 SCM02503 SCM02506 SCM02514 SCM02516 SCM02517 SCM02519 SCM02520 SCM02521 SCM02522 SCM02523 SCM02524 SCM02525 SCM02526 SCM02531 SCM02532 SCM02533 SCM02534 SCM02535 SCM02536 SCM02537 SCM02542 SCM02543 SCM02545 SCM02546 SCM02547 SCM02548 SCM02549 SCM02550 SCM02552 SCM02553 SCM02554 SCM02555 SCM02557 SCM02558 SCM02559 SCM02561 SCM02562 SCM02563 SCM02564 SCM02568 SCM02569 SCM02570 SCM02571 SCM02572 SCM02573 SCM02575 SCM02576 SCM02577 SCM02578 SCM02579 SCM02580 SCM02581 SCM02584 SCM02585 SCM02586 SCM02588 SCM02589 SCM02590 SCM02591 SCM02592 SCM02593 SCM02594 SCM02595 SCM02596 SCM02597 SCM02598 SCM02599 SCM02600 SCM02601 SCM02605 SCM02606 SCM02607 SCM02608 SCM02609 SCM02611 SCM02612 SCM02613 SCM02614 SCM02615 SCM02616 SCM02617 SCM02618 SCM02619 SCM02620 SCM02621 SCM02622 SCM02623 SCM02624 SCM02627 SCM02628 SCM02629 SCM02630 SCM02631 SCM02632 SCM02633 SCM02637 SCM02640 SCM02641 SCM02642 SCM02643 SCM02644 SCM02645 SCM02646 SCM02648 SCM02649 SCM02650 SCM02651 SCM02652 SCM02654 SCM02655 SCM02656 SCM02657 SCM02658 SCM02659 SCM02660 SCM02661 SCM02662 SCM02664 SCM02665 SCM02666 SCM02667 SCM02670 SCM02673 SCM02674 SCM02675 SCM02676 SCM02677 SCM02678 SCM02679 SCM02680 SCM02681 SCM02682 SCM02683 SCM02684 SCM02687 SCM02689 SCM02690 SCM02691 SCM02692 SCM02694 SCM02695 SCM02696 SCM02698 SCM02699 SCM02700 SCM02701 SCM02702 SCM02703 SCM02705 SCM02706 SCM02707 SCM02708 SCM02709 SCM02710 SCM02711 SCM02712 SCM02713 SCM02714 SCM02715 SCM02716 SCM02717 SCM02718 SCM02719 SCM02720 SCM02721 SCM02722 SCM02723 SCM02724 SCM02725 SCM02726 SCM02727 SCM02728 SCM02729 SCM02730 SCM02731 SCM02732 SCM02733 SCM02735 SCM02736 SCM02737 SCM02738 SCM02739 SCM02740 SCM02741 SCM02742 SCM02743 SCM02744 SCM02745 SCM02746 SCM02747 SCM02748 SCM02749 SCM02750 SCM02751 SCM02753 SCM02754 SCM02755 SCM02756 SCM02757 SCM02758 SCM02759 SCM02760 SCM02761 SCM02762 SCM02763 SCM02764 SCM02765 SCM02767 SCM02768 SCM02769 SCM02770 SCM02771 SCM02774 SCM02775 SCM02776 SCM02778 SCM02779 SCM02781 SCM02782 SCM02783 SCM02784 SCM02785 SCM02786 SCM02787 SCM02788 SCM02789 SCM02790 SCM02791 SCM02792 SCM02793 SCM02794 SCM02795 SCM02796 SCM02797 SCM02798 SCM02799 SCM02800 SCM02801 SCM02803 SCM02804 SCM02805 SCM02807 SCM02808 SCM02809 SCM02810 SCM02812 SCM02813 SCM02814 SCM02815 SCM02816 SCM02817 SCM02818 SCM02819 SCM02820 SCM02821 SCM02822 SCM02823 SCM02824 SCM02825 SCM02826 SCM02827 SCM02828 SCM02829 SCM02830 SCM02831 SCM02832 SCM02834 SCM02835 SCM02836 SCM02837 SCM02840 SCM02841 SCM02842 SCM02843 SCM02844 SCM02845 SCM02846 SCM02849 SCM02850 SCM02851 SCM02852 SCM02853 SCM02854 SCM02855 SCM02856 SCM02857 SCM02858 SCM02859 SCM02860 SCM02861 SCM02863 SCM02864 SCM02865 SCM02866 SCM02867 SCM02868 SCM02869 SCM02870 SCM02871 SCM02872 SCM02873 SCM02874 SCM02875 SCM02876 SCM02877 SCM02878 SCM02879 SCM02880 SCM02881 SCM02882 SCM02883 SCM02886 SCM02888 SCM02889 SCM02890 SCM02891 SCM02892 SCM02893 SCM02894 SCM02895 SCM02897 SCM02898 SCM02899 SCM02900 SCM02901 SC... | 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-0961-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR; and OUS (foreign) to countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, Gaza & Jericho, Georgia, Germany, Greece, Greenland, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Montenegro, Morocco, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, Ukraine, United Kingdom, Uruguay, Vietnam and Zambia. OUS: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FAROE ISLANDS, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GREENLAND, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAWI, MALAYSIA, MALDIVES, MALTA, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MOROCCO, NAMIBIA, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA (CIS), RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VIETNAM, ZAMBIA 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 24, 2025 - **Recall initiation date**: Nov 13, 2025 - **Center classification date**: Dec 18, 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-0961-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abbott Laboratories records](https://isitonrecall.com/brand/abbott-laboratories/)