Recalls affecting Connecticut

FDA has not published a risk classification for this recall yet.

Recall #:

98208

Lot/product code:

Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967

Recalling firm:

SunMed Holdings, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722001; System Product Name: Allura Xper FD10C; UDI-DI: N/A; Serial Numbers: 166, 181, 153, 274, 296, 267, 206, 247, 161, 282, 213, 284, 103, 199, 129, 95, 299, 30, 235, 221, 348, 283, 276, 253, 1100, 78, 229, 232, 159, 177, 219, 217, 205, 3, 89, 101, 295, 305;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98208

Lot/product code:

Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151

Recalling firm:

SunMed Holdings, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

98274

Lot/product code:

Lot Code:W4904253, W4886945, W4880750 UDI: 10827002223018

Recalling firm:

Wilson-Cook Medical Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98219

Lot/product code:

UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)

Recalling firm:

Immunotech A.S.

FDA has not published a risk classification for this recall yet.

Recall #:

98187

Lot/product code:

REF: 430073 UDI: 00886874119549 Lot Numbers: U80240110 K10250114 K10250305 K10250306 K10250313 K10250414 K10250424 K10250514 K10250522 K10250619 K10250626 K10250629 K10250630 K10250710 K10250716 K10250717 K10250731 K10250804 K10250806 K10250828 K10250904 K11250113 K11250807 K11250821 K11250828 K11250911 K12250821 U10241101 U10241115 U10250108 U10250207 U10250210 U10250307 U10250310 U10250313 U10250321 U10250325 U10250331 U10250414 U10250425 U10250506 U10250509 U10250521 U10250528 U10250604 U11241101 U11241121 U11241210 U11250123 U11250219 U11250404 U11250425 U11250521 U12250219 U80231207 U80231219 U80240118 U80240125 U80240201 U80240222 U80240306 U80240319 U80240402 U80240411 U80240417 U80240523 U80240617 U80240620 U80240806 U80240812 U80240905 U80240911 U80241017 U80241025 U81231219 U81240118 U81240125 U81240306 U81240319 U81240402 U81240411 U81240417 U81240617 U81240620 U81240627 U81240806 U81240905 U81240911 U82231219 REF: 430075 UDI: 00886874119556 Lot Numbers: U81240125 U80240201 U80240222 U80240125 U81240215 U81240208 U80240208 U81240201 U81240229 U80240326 U80240529 U80240229 U81240222 U80240711 U81240606 U80240606 U80240812 U80240731 U80240917 U10241107 U80241003 U10241217 U10250123 U10250305 U10250219 U10250102 K10250313 U10250414 U10250423 K10250529 K10250522 U10250529 K10250701 K10250702 K10250717 K11250814 K10250807 K11250813 K10250605 U80240611 K10250327 U80240425 U10250312 K10250515 K11250515 U10250318 U80240724 U10250115 U10250326 U80240130 U80240627 K10250113 K11250529 K10250723 U80240717 U80240215 U10250501 K10250403 U10250515 K12250904

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722006; System Product Name: Allura Xper FD20; UDI-DI: N/A; Serial Numbers: 1370, 1376, 225, 249, 1273, 1496, 707, 1466, 1141, 1201, 359, 105, 285, 1433, 822, 1747, 318, 797, 124, 1518, 384, 1045, 328, 302, 1536, 514, 910, 2123, 1360, 1381, 149, 379, 387, 1733, 197, 314, 888, 189, 310, 209, 863, 325, 378, 2110, 166, 118, 1978, 304, 1696, 2524, 248, 1928, 294, 804, 1227, 56, 245, 1560, 1795, 902, 1295, 1123, 1424, 1958, 40, 1222, 1947, 2289, 1687, 2304, 666, 2086, 958, 1801, 2546, 1317, 1478, 589, 2154, 1557, 1580, 519, 273, 157, 1504, 836, 1365, 393, 2428, 1902, 2433, 1521, 115, 2023, 1003, 1509, 1494, 2171, 2391, 867, 1513, 29, 951, 1814, 284, 482, 455, 1763, 1899, 1968, 837, 856, 1537, 93, 1561, 1746, 1232, 430, CV.797, 1974, 507, 1949, 1275, 1427, 1967, 374, 116, CV.507, 7567201, 2225, 267, 931, 344, 745, 233, 506, 2230, 1864, 457, 280, 1556, 640, 2;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722011; System Product Name: Allura Xper FD10/10; UDI-DI: 00884838059047; Serial Numbers: 268, 205, 213, 89, 293, 294, 116, 272, 113, 152, 112, 139, 141, 111, 81, 66, 46, 153, 115, 114, 274;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98163

Lot/product code:

Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.

Recalling firm:

Diagnostica Stago, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722026; System Product Name: Allura Xper FD10; UDI-DI: 00884838054189; Serial Numbers: 969, 223, 648, 664, 622, 931, 128, 616, 497, 769, 143, 881, 809, 18, 326, 794, 174, 804, 424, 587, 172, 911, 294, 569, 141, 161, 182, 928, 960, 858, 494, 628, 749, 968, 17, 273, 43, 203, 546, 104, 430, 575, 180, 594, 359, 723, 779, 632, 183, 330, 726, 637, 300, 429, 810, 995, 293, 296, 573, 917, 695, 676, 913, 274, 734, 520, 27, 940, 597, 598, 301, 818, 916, 328, 912, 691, 410, 873, 868, 816, 732, 147, 742, 651, 919, 89, 918, 346, 250, 755, 199, 255, 524, 256, 623;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722027; System Product Name: Allura Xper FD10/10; UDI-DI: 00884838054196; Serial Numbers: 298, 246, 146, 170, 238, 162, 7, 99, 81, 126, 55, 86, 6, 259, 205, 60, 57, 63, 145, 182, 48, 278;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722013; System Product Name: Allura Xper FD20 Biplane; UDI-DI: 00884838059061; Serial Numbers: 601, 230, 370, 27, 320, 193, 60, 373, 560, 400, 549, 506, 381, 382, 132, 169, 233, 236, 243, 526, 447, 163, 403;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722023; System Product Name: Allura Xper FD20 OR Table; UDI-DI: 00884838059085; Serial Numbers: 103, 10, 85, 125;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98128

Lot/product code:

400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98208

Lot/product code:

Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209

Recalling firm:

SunMed Holdings, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

98129

Lot/product code:

UDI-DI: M335400021; Serial Numbers: 50000221 50000294 50000295 50000296 50000298 50000299 50000300 50000303 50000304 50000309 50001663 50001664 50001665 50001666 50001667 50001668 50001669 50001670 50001671 50001672 50001673 50001674 50001675 50001676 50001677 50001678 50001679 50001680 50001681 50001682 50001683 50001684 50001685 50001686 50001687 50001688 50001689 50001690 50001691 50001692 50001693 50001694 50001695 50001696 50001697 50001698 50001699 50001700 50001701 50001702 50001703 50001704 50001705 50001706 50001707 50001708 50001709 50001710 50001711 50001712 50001713 50001714 50001715 50001716 50001717 50001718 50001719 50001720 50001721 50001722 50001723 50001724 50001725 50001726 50001727 50001728 50001729 50001730 50001731 50001732 50001733 50001734 50001735 50001736 50001737 50001738 50001739 50001740 50001741 50001742 50001743 50001744 50001745 50001746 50001747 50001748 50001749 50001750 50001751 50001752 50001753 50001754 50001755 50001756 50001757 50001758 50001759 50001760 50001761 50001762 50001763 50001765 50001766 50001768 50001770 50001771 50001772 50001773 50001774 50001775 50001776 50001777 50001778 50001779 50001780 50001781 50001782 50001783 50001784 50001785 50001786 50001787 50001788 50001789 50001790 50001791 50001792 50001793 50001794 50001795 50001796 50001797 50001798 50001799 50001800 50001801 50001802 50001803 50001804 50001805 50001806 50001807 50001809 50001810 50001811 50001812 50001813 50001814 50001815 50001816 50001817 50001818 50001819 50001820 50001821 50001822 50001823 50001824 50001825 50001826 50001827 50001828 50001829 50001831 50001833 50001834 50001835 50001836 50001837 50001838 50001839 50001840 50001841 50001842 50001843 50001844 50001845 50001846 50001847 50002285 50003548 50003626 50003702 50003703 50003704 50003705 50003706 50003707 50003708 50003709 50003710 50003712 50003713 50003715 50003716 50003717 50003718 50003719 50003720 50003722 50003723 50003725 50003726 50003727 50003728 50003730 50003732 50003733 50003734 50003735 50003736 50003737 50003738 50003740 50003741 50003742 50003743 50003745 50003746 50003747 50003748 50003749 50003751 50003752 50003754 50003755 50003756 50003757 50003758 50003759 50003760 50003761 50003762 50003763 50003764 50003765 50003766 50003767 50003768 50003770 50003771 50003774 50003775 50003776 50003777 50003779 50003784 50003785 50003786 50003787 50003789 50003792 50003793 50003794 50003797 50003798 50003799 50003800 50003801 50003802 50003803 50003804 50003805 50003807 50004219 50004913 50004939 50005129 50005199 50000004 50000005 50000006 50000008 50000009 50000010 50000011 50000012 50000013 50000014 50000015 50000016 50000017 50000018 50000019 50000020 50000021 50000022 50000023 50000024 50000025 50000026 50000027 50000028 50000030 50000031 50000032 50000034 50000035 50000036 50000037 50000038 50000039 50000041 50000042 50000043 50000044 50000045 50000047 50000048 50000049 50000050 50000051 50000052 50000053 50000055 50000056 50000057 50000058 50000059 50000060 50000061 50000063 50000064 50000065 50000066 50000067 50000068 50000069 50000070 50000071 50000072 50000073 50000074 50000075 50000076 50000077 50000078 50000079 50000080 50000081 50000083 50000084 50000085 50000087 50000088 50000089 50000090 50000092 50000093 50000094 50000095 50000096 50000097 50000098 50000099 50000100 50000101 50000104 50000105 50000106 50000107 50000108 50000109 50000110 50000112 50000113 50000114 50000115 50000116 50000117 50000007 50000033 50000046 50000054 50000062 50000082 50000091 50000102 50000103 50000111 50000249 50000273 50000277 50000283 50000306 50000311 50003711 50003714 50003721 50003724 50003729 50003731 50003739 50003744 50003750 50003769 50003772 50003778 50003782 50003783 50003788 50003790 50003791 50003795 50003806 50003808 50003809 50003810 50004066 50004274 50004364 50001764 50001830

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722029; System Product Name: Allura Xper FD20/10; UDI-DI: 00884838054219; Serial Numbers: 30, 81, 80, 47;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98172

Lot/product code:

Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.

Recalling firm:

Hologic, Inc

FDA has not published a risk classification for this recall yet.

Recall #:

98176

Lot/product code:

Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016, C10017 UDI-DI: 08437019546076

Recalling firm:

LEASEIR TECHNOLOGIES SLU

FDA has not published a risk classification for this recall yet.

Recall #:

98213

Lot/product code:

Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075

Recalling firm:

Sysmex America, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722038; System Product Name: Allura Xper FD20/20; UDI-DI: 00884838054226; Serial Numbers: 11, 117, 110, 134, 64, 90, 124, 72;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

98109

Lot/product code:

Model Number: 722028; System Product Name: Allura Xper FD20; UDI-DI: 00884838054202; Serial Numbers: 893, 614;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:

D-0300-2026

Lot/product code:

Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027

Recalling firm:

NOVADOZ PHARMACEUTICALS LLC

FDA has not published a risk classification for this recall yet.

Recall #:

98128

Lot/product code:

400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98128

Lot/product code:

400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0

Recalling firm:

ICU Medical, Inc.