Recalls affecting Arizona

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0254-2026

Lot/product code:

Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.

Recalling firm:

SpecGx, LLC

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

Recall #:

98255

Lot/product code:

1. 25GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2. 25GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3. 25GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057

Recalling firm:

Vortex Surgical Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0255-2026

Lot/product code:

Lot: 0522J23493, expires: 03/2027.

Recalling firm:

SpecGx, LLC

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

Recall #:

D-0248-2026

Lot/product code:

Lot# 2405003360, Exp Date: Jan 31, 2026

Recalling firm:

Alembic Pharmaceuticals Limited

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.

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:

D-0397-2026

Lot/product code:

All codes; Exp 12/31/2029

Recalling firm:

StuffbyNainax

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

Recall #:

98208

Lot/product code:

Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974

Recalling firm:

SunMed Holdings, LLC

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.

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 #:

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: 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 #:

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: 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 #:

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: 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 #:

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 #:

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 #:

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 #:

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 #:

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 #:

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: 722008; System Product Name: Allura Xper FD20 Biplane; UDI-DI: N/A; Serial Numbers: 296, 245, 141, 260, 13, 410, 196, 476, 488, 290, 339, 474, 383, 530, 722008530, 223, 468, 63;

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 #:

98176

Lot/product code:

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

Recalling firm:

LEASEIR TECHNOLOGIES SLU