Recalls affecting Delaware

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

Recall #:

98109

Lot/product code:

Model Number: 722002; System Product Name: Allura Xper FD10F; UDI-DI: N/A; Serial Numbers: 61, 56, 27, 81, 25, 85, 20, 21, 84, 50, 31, 40;

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: 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 #:

98109

Lot/product code:

Model Number: 722005; System Product Name: Allura Xper FD10/10; UDI-DI: N/A; Serial Numbers: 93, 269, 530, 306, 307, 247, 53, 401, 141, 531, 184, 75, 276, 36;

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.

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 #:

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) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151

Recalling firm:

SunMed Holdings, LLC

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 #:

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 #:

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: 722012; System Product Name: Allura Xper FD20; UDI-DI: 00884838059054; Serial Numbers: 2942, 1515, 1189, 1594, 535, 1964, 2156, 2742, 2092, 1673, 1803, 1655, 2020, 1973, 2037, 1853, 2098, 1248, 1082, 1576, 1057, 1129, 646, 930, 1421, 462, 203, 627, 2005, 1428, 353, 288, 191, 1994, 1802, 156, 853, 1283, 1956, 2361, 1980, 872, 931, 1295, 2513, 1090, 1374, 468, 1822, 812, 1379, 1817, 1580, 1050, 309, 144, 1841, 1845, 1468, 558, 1968, 1959, 2168, 1168, 1562, 967, 2114, 47, 167, 2091, 2053, 604, 603, 217, 2918, 373, 850, 1820, 1821, 1619;

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) 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 #:

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 #:

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 #:

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: 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: 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 #:

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 #:

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 #:

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 #:

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 #:

98109

Lot/product code:

Model Number: 722010; System Product Name: Allura Xper FD10; UDI-DI: 00884838059030; Serial Numbers: 764, 1396, 728, 980, 782, 125, 1096, 661, 225, 1055, 1185, 368, 743, 1006, 570, 901, 552, 973, 795, 888, 1140, 781, 1060, 354, 186, 516, 517, 64, 386, 387, 530, 996, 964, 1265, 525, 307, 1189, 98, 774, 935, 721, 254, 1008, 1213, 1273, 66, 156, 304, 1422, 388, 235, 236, 1066, 1090, 549, 689;

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.

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.