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Recalls affecting New York

Data last updated: September 10, 2026 at 1:16 PM UTC

17,381 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

ALL 50 STATES
Full report

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

Recall #:
98495
Lot/product code:
Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270730(10)16183353X, Lot Number 16183353X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270524(10)16076948, Lot Number 16076948; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260222(10)15473203X, Lot Number 15473203X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260201(10)15476984X, Lot Number 15476984X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)261020(10)15719188X, Lot Number 15719188X; Reference Part Number C-PTISY-100-UNL-HC-G-NA, UDI (01)00827002577060(17)270814(10)16205108, Lot Number 16205108; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270528(10)16080161X, Lot Number 16080161X; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270901(10)16435112, Lot Number 16435112.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

ALL 50 STATES
Full report

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

Recall #:
98495
Lot/product code:
Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270221(10)NS15796862X, Lot Number NS15796862X; Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270301(10)NS15881832X, Lot Number NS15881832X.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 5, 2026

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

Not guaranteed to be germ-free

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Full report

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

Recall #:
D-0407-2026
Lot/product code:
Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

ALL 50 STATES
Full report

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

Recall #:
98495
Lot/product code:
Reference Part Number C-CAE-14.0-83-EXTU, UDI (01)00827002240735(17)270509(10)16010654, Lot Number 16010654.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 4, 2026

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

ALL 50 STATES
Full report

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

Recall #:
98556
Lot/product code:
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Recalling firm:
Koven Technology, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722068; UDI: 00884838085367; System Serial Number: 547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42, 153, 324, 323, 320, 85, 89, 109, 407, 239, 505, 271, 443, 104, 370, 322, 136, 373, 442, 524, 308, 354, 75, 279, 400, 196, 510, 110, 446, 78, 330, 73, 288, 285, 295, 406, 528, 329, 184, 350, 462, 304, 457, 470, 472, 319, 520, 490, 243, 103, 479, 261, 262, 150, 277, 172, 117, 130, 356, 143, 146, 84, 251, 469, 431, 361, 76, 374, 270, 114, 511, 477, 232, 137, 282, 487, 413, 337, 101, 213, 82, 265, 275, 485, 459, 276, 62, 506, 608, 473, 417, 302, 314, 88, 126, 211, 468, 422, 454, 410, 283, 231, 548, 466, 495, 207, 167, 445, 537, 438, 173, 233, 289, 536, 192, 204, 77, 166, 313, 236, 133, 481, 280, 307, 577, 210, 258, 328, 325, 199, 480, 53, 72, 364, 491, 423, 509, 246, 614, 142, 376, 539, 257, 140, 369, 195, 500, 508, 97, 87, 303, 48, 44, 301, 550, 460, 118, 293, 551, 478, 522, 568, 448, 242, 238, 68, 160, 83, 544, 230, 434, 435, 360, 93, 36, 372, 179, 306, 182, 583, 327, 244, 382, 428, 432, 215, 447, 338, 399, 339, 316, 555, 552, 570, 347, 148, 134, 38, 560, 158, 535, 318, 518, 250, 336, 185, 206, 50, 489, 521, 37, 79, 529, 111, 254, 427, 394, 71, 47, 534, 292, 497, 591, 35, 227, 359, 527, 387, 168, 128, 129, 396, 515, 486, 543, 69, 453, 174, 483, 484, 334, 425, 181, 408, 415, 141, 365, 471, 540, 584, 553, 602, 240, 617, 604, 593, 589, 526, 559, 612, 450, 556, 557, 574, 603, 601, 609, 616, 597, 605, 575, 516, 624, 599, 563, 590, 198, 600, 228, 380, 420, 397, 212, 475, 180, 268, 269, 414, 74, 562, 115, 349, 291, 519, 234, 219, 532, 533, 60, 398, 618, 549, 46, 96, 416, 249, 531, 426, 162, 290, 346, 49, 326, 286, 125, 102, 113, 124, 138, 362, 127, 145, 299, 317, 571, 187, 183, 45, 331, 106, 465, 281, 112, 501, 393, 116, 273, 188, 264, 139, 503, 122, 439, 135, 248, 404, 390, 263, 90, 300, 224, 67, 61, 157, 154, 100, 217, 253, 391, 144, 379, 202, 105, 226, 315, 464, 197, 63, 252, 175, 274, 163, 186, 260, 502, 152, 498, 156, 621, 296, 208, 430, 161, 436, 409, 155, 298, 191, 278, 368, 94, 66, 108, 200, 201, 98, 189, 311, 367, 297, 132, 507, 451; (2) System Code: 722226; UDI: 00884838099272; System Serial Number: 120, 122, 123, 124, 125, 126, 127, 153, 67, 209, 271, 675, 112, 1052, 1091, 113, 121, 139, 158, 1078, 1145, 239, 105, 678, 114, 362, 758, 403, 702, 108, 545, 197, 380, 281, 688, 592, 593, 495, 319, 687, 921, 182, 183, 325, 690, 100, 272, 680, 724, 350, 891, 280, 270, 254, 107, 144, 761, 681, 691, 779, 294, 845, 559, 116, 343, 98, 301, 117, 876, 1021, 244, 332, 781, 782, 534, 341, 374, 78, 11, 441, 129, 180, 918, 442, 220, 555, 189, 190, 871, 446, 842, 255, 848, 208, 554, 955, 360, 337, 159, 400, 757, 326, 323, 175, 427, 464, 468, 778, 683, 143, 262, 482, 971, 391, 392, 173, 793, 147, 204, 467, 1017, 260, 381, 912, 410, 508, 419, 313, 472, 894, 318, 473, 383, 689, 973, 463, 823, 181, 205, 361, 59, 756, 379, 1008, 266, 1002, 398, 75, 786, 19, 1125, 213, 214, 215, 1007, 814, 969, 970, 469, 219, 462, 296, 149, 704, 573, 458, 987, 141, 711, 693, 510, 882, 226, 509, 584, 21, 1050, 647, 225, 201, 202, 303, 666, 184, 243, 178, 179, 250, 1139, 674, 1062, 575, 1121, 368, 950, 861, 176, 712, 829, 413, 997, 249, 589, 1046, 708, 738, 1083, 717, 697, 1126, 665, 416, 386, 764, 977, 595, 859, 1113, 721, 1043, 797, 957, 1006, 498, 60, 232, 423, 682, 789, 698, 331, 1097, 1094, 378, 808, 1107, 393, 949, 718, 663, 195, 411, 1092, 412, 715, 1143, 775, 1073, 982, 282, 785, 617, 958, 221, 222, 604, 430, 1027, 1067, 415, 810, 1114, 61, 1147, 314, 822, 561, 1026, 1102, 762, 306, 359, 978, 1060, 972, 83, 199, 1013, 920, 1136, 898, 835, 836, 795, 671, 799, 800, 899, 905, 838, 944, 1123, 335, 363, 1039, 731, 399, 869, 725, 701, 626, 967, 623, 744, 501, 953, 1018, 513, 533, 677, 449, 119, 367, 927, 480, 732, 974, 344, 824, 984, 487, 919, 605, 230, 523, 686, 327, 1138, 424, 684, 477, 1049, 298, 809, 10, 227, 520, 521, 522, 993, 874, 259, 140, 628, 530, 506, 909, 142, 733, 263, 490, 494, 633, 634, 396, 547.631, 514, 642, 505, 321, 754, 17, 422, 1057, 420, 247, 99, 36, 432, 539, 88, 245, 911, 132, 133, 667, 5, 1103, 188, 586, 14, 622, 228, 4, 1069, 45, 316, 164, 485, 448, 507, 97, 351, 497, 685, 771, 790, 1076, 543, 66, 542, 550, 551, 484, 504, 714, 1054, 366, 18, 1048, 893, 1132, 217, 752, 1088, 47, 544, 148, 408, 906, 289, 548, 238, 299, 283, 284, 401, 404, 827, 833, 84, 692, 895, 118, 924, 224, 233, 1087, 579, 515, 455, 946, 599, 726, 676, 395, 670, 1, 261, 444, 826, 93, 956, 1077, 900, 901, 320, 355, 710, 435, 1072, 820, 749, 235, 846, 727, 621, 1129, 1041, 777, 1053, 274, 486, 1014, 1015, 503, 1071, 431, 481, 460, 765, 194, 696, 1099, 25, 451, 438, 275, 552, 352, 87, 630, 1047, 941, 345, 349, 429, 854, 1009, 888, 369, 557, 585, 596, 342, 457, 645, 739, 736, 1127, 963, 527, 251, 1115, 1000, 965, 553, 1042, 699, 1064, 574, 741, 748, 1137, 887, 632, 1118, 737, 1131, 1148, 1111, 907, 662, 825, 1075, 877, 1134, 1023, 648, 831, 1135, 751, 1061, 1036, 1104, 830, 1152, 860, 798, 603, 577, 938… (truncated, 7713 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); UDI-DI: 25051684007914(Box), 15051684007917(Pouch); Lot No.: A2525098;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); UDI-DI: 25051684007938(Box), 15051684007931(Pouch); Lot No.: A2825145;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.

ALL 50 STATES
Full report

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

Recall #:
98539
Lot/product code:
UDI/DI 5032384127498, Lot Number 4494873
Recalling firm:
Oxoid Australia Pty Limited
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); UDI-DI: 25051684006177 (Box), 15051684006170 (Pouch); Lot No.: A3325043;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); UDI-DI: 25051684007778(Box), 15051684007771(Pouch); Lot No.: A2425078, A3325036, A3525030, A3525031, A3725102;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Allura Xper FD10C; System Code: 722001;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
System Code: 722001; UDI: N/A; System Serial Number: 19, 249, 21, 18661014, 77, 82, 195, 216, 337, 37, 258, 283, 15, 256, 305;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); UDI-DI: 25051684007785(Box), 15051684007788(Pouch); Lot No.: A2525060, A2525061, A3625006, A3625007;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Allura Xper FD20/10; System Code: 722029;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
System Code: 722029; UDI: 00884838059078; System Serial Number: 57, 7, 88, 56, 126, 94, 30, 31, 21, 97, 91, 110, 100, 63, 60, 55, 62, 129, 71, 36, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 127, 14, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 50, 51, 124, 87, 20, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); UDI-DI: 25051684009727(Box), 15051684009720(Pouch); Lot No.: A2825022, A3025035, A3025037;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); UDI-DI: 25051684008102(Box), 15051684008105(Pouch); Lot No.: A2725049;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722022; UDI: 00884838059078; System Serial Number: 6; (2) System Code: 722033; UDI: 00884838054233; System Serial Number: 1;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169, 305, 565, 419, 269, 258, 346, 474, 497, 530, 261, 523, 384, 388, 271, 233, 367, 270, 427, 343, 399, 360, 212, 251, 112, 520, 70, 392, 128, 357, 485, 405, 306, 307, 467, 234, 287, 333, 533, 209, 369, 543, 332, 328, 366, 389, 538, 394, 378, 379, 237, 165, 238, 2724, 415, 482, 397, 53, 385, 52, 531, 58, 499, 229, 374, 25, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 511, 428, 500, 463, 464, 14, 459, 416, 359, 487, 74, 457, 564, 469, 72, 125, 494, 519, 373, 76; (2) System Code: 722011; UDI: 00884838059047; System Serial Number: 49, 137, 375, 332, 102, 103, 95, 107, 380, 132, 171, 157, 270, 362, 76, 79, 22, 234, 308, 34, 324, 177, 84, 82, 319, 17, 133, 168, 345, 344, 83, 59, 15, 170, 163, 101, 255, 173, 325, 87, 155, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 186, 300, 213, 372, 41, 55, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 74, 75, 301, 302, 303, 304, 305, 306, 307, 18, 293, 294, 184, 266, 146, 116, 68, 310, 88, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 139, 141, 99, 277, 313, 223, 27, 29, 26, 340, 69, 367, 374, 328, 228, 251, 231, 323, 224, 81, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 377, 376, 378, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 244, 287, 38, 176, 39, 282, 329, 246, 295, 337, 292, 125; (3) System Code: 722027; UDI: 00884838054196; System Serial Number: 351, 332, 1, 71, 319, 43, 101, 29, 50, 112, 240, 241, 175, 298, 280, 107, 183, 202, 164, 153, 335, 288, 342, 134, 156, 265, 306, 307, 152, 106, 169, 203, 234, 209, 267, 284, 263, 127, 116, 174, 39, 49, 56, 120, 123, 133, 305, 246, 255, 40, 178, 104, 42, 266, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 292, 293, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 334, 338, 162, 273, 5, 160, 61, 36, 299, 294, 345, 76, 94, 348, 349, 350, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 165, 81, 126, 268, 356, 244, 55, 86, 254, 6, 117, 362, 271, 186, 259, 236, 201, 275, 135, 277, 58, 249, 148, 149, 38, 47, 316, 27, 274, 80, 64, 205, 223, 270, 181, 221, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 145, 214, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 242, 243, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 21, 23, 24, 65;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722006; UDI: N/A; System Serial Number: 1706, 1730, 1936, 2250, 518, 1260, 1831, 1095, 1096, 1370, 1564, 2269, 471, 1293, 1762, 1764, 225, 1832, 204, 1818, 778, 2587, 1092, 1273, 2274, 2569, 1425, 1496, 707, 1448, 1466, 2183, 1502, 2201, 920, 1654, 1707, 1206, 637, 1326, 2152, 637220, 2536, 861, 172, 529, 1711, 1201, 1363, 2027, 2187, 730, 616, 550, 2336, 1407, 1259, 1913, 674, 1477, 2454, 1081, 272, 2021, 1118, 2126, 771, 2574, 1740, CV.514, 283, 1323, 1604, 1366, 2606, 268, 2366, 1256, 1755, 2140, 599, 2161, 2612, 683, 1942, 1352, 1780, 2062, 852, 853, 95, 188, 968, 2577, 2585, 722008-358, 1932, 2066, 1139, 285, 1433, 822, 823, 1744, 1747, 1752, 1341, 1601, 269, 2548, 1420, 1328, 1922, 797, 2122, 929, 1827, 316, 1648, 2070, S01H006016/000001, 1439, 1659, 1093, 1886, 1854, 1888, 1587, 705, 2537, 121, 1237, 1490, 1441, 1518, 658, 1896, 141, 90, 384, 1523, 327, 606, 849, 2571, 215, 848, 904, 551, 1469, 1830, 289, 186, 2217, 1629, 1865, 588, 1391, 161, 2568, 886, 1346, 587, 2200, 2522, 535, 2323, 435, 1583, 1585, 1536, 1911, 1174, 1914, 826, 2296, 2608, 1560, 1761, 1550, 1844, 1848, 2045, 1589, 91, 2430, 753, 127, 2297, 1185, 504, 1843, 664, 2199, 1868, 1120, 1941, 2610, 595, 638, 1085, 18268, 723, 893, 2347, 1790, CV.740, 1209, 149, 2523, 1364, 2268, 211, 972, 661, 774, 1729, 1612, 1588, 2530, 1351, 1723, 2002, 1710, 2058, S4F621389A000001, 1872, 2042, 24, 992, 2380, 2525, 828, 91A, 2272, 353, 680, 1169, 1641, 37, 1627, 1338, 2562, 317, 331, 1807, 1476, 469, 1534, 889, 287, 1833, 1733, 2159, 1609, 679, 1731, 633056, 2088, 468, 2564, 187, 1661, 1578, 843, 1987, 2054, 702, 1235, 2143, 2051, 265, 1000, 1653, 167, 314, 2324, 1766, 1473, 2390, 1480, 1881, 2533, 1380, 2198, 168, 1318, 2823014, 2203, 1575, 2283, 1750, 1443, 2256, 780, 1507, 2009, 2195, 810, 1856, 1239, 372, 800, 1050, 1511, 1168, 1631, 1956, 722, 347, 2565, 1147, 553, 2135, 1774, 1446, 1908, 691, 2181, 1977, 1594, 2326, 2110, 1603, 166, 135, 2131, 731, 2425, 2106, 2111, 2112, 308, 2573, 2003, 226, 1978, 72246F, 1696, 52, 1242, 1211, 140, 1177, 1754, 521, 2382, 1890, 2281, 2097, 1600, 2427, 1274, 2147, 2607, 1611, 75289, 1900, 612, 2524, 295, CV.271, 913, 2184, 1637, 1582, 1921, 301, 1615, 1007, 1104, 1845, 641, 1927, 1928, 159, 2570, 1107, 2028, 1621, 1640, 1670, 1114, 1115, 1116, 1127, 1H041985, 1387, 1445, 120, 2462, 43074, 1939, 2301, 1734, 1383, 1046, 1361, 47, 1875, 1276, 234, 878, 315, 655, 914, 1277, 2456, 1302, 376, 767, 221, 1955, 1639, 207, 1727, 804, 2561, 781, 1227, 860, 830, 1289, 1306, 425, 343, 2158, 530, 2155, 2013, 1373, 1983, 2286, 1100, 1270, 1591, 2318, 1022, 1838, 1125, 1089, 511, 1307, 833, 1712, 1198, 812, 2392, 594, 794, 1741, 1349, 1454, 1455, 1456, 1751, 2053, 424, 1917, 1667, 2038, 1460, STOR_DEMO_17391651, 1401, 33, 1965, 2416, 1819, 902, 609, 492, 2104, 2348, 2423, 1925, 346, 1552, 1999, 1704, 2488, 1117, 1295, 2247, 1424, 717, 2137, 2278, 1222, 1253, 1947, 2293, 2079, 2124, 1687, 1129, 2529, 1791, 8, 2584, 2049, 2173, 808, 1158, 590, 2043, 1350, 1213, 994, 1859, 2304, 1692, 1264, 1524, 2528, 740, NA, 31, 2086, 941, 958, 2531, 2046, 2371, 1468, 1801, 2514, 768, 1316, 1075, 2551, 460, 2368, 1193, 1605, 2145, 2176, 1753, 1851, 578, 1708, 2175, 2129, 1317, 589, 1180, 1517, 2580, 687, 1652, 2154, 1203, 2342, 1557, 2527, 2550, 1884, 100079164-1971, 1580, 519, 600, 2373, 417, 2031, 1504, 491, 2179, 1784, 2061, 2538, 2428, 1602, 1542, NL94, 2214, 971, 1997, 1824, 859, 1021, 1802, 2085, 2103, 1452, 1808, 1533, 820, 2541, 462, 63, 2023, 2465, 2182, 2343, 2206, 2411, 1246, 1003, 1509, 659, 2526, 614, 2015, 1969, 866, 2194, 336, 2553, 880, 2555, 922, 1598, 1549, 2034, 689, 2114, 1494, 819, 2040, 2069, 2171, 1062, 1759, 585, 2219, 2228, 2259, 2063, 1823, 608, 1554, 1916, 2279, 2192, 1233, 1793, 1919, 2399, 854, 516, 2039, 1967, 867, 1513, 1031, 1817, 1505, 2288, 1991, 1347, 2292, 1948, 951, 2150, 2434, 1892, 1130, 1617, 955, 1961, 2144, 1344, 1988, 2064, 1284, 1529, 1814, 1515, 284, 1678, 428, 1815, 1463, 2244, 1891, 2305, 1336, 1004, 1106, 1787, 946, 952, 482, 455, 1763, 1985, 1899, 1777, 1968, 2438, 1650, 887, 1992, 2094, 811, 2041, 1840, 2360, 837, 2325, 856, 2022, 408, 2369, 1537, 1893, 1538, 380, 2115, 1715, 925, 2101, 1998, 2109, 1714, 2245, 2314, 2291, 1880, 1561, 873, 1746, 102, 2080, 2255, 2307, 2162, 1530, 2095, 1232, 1343, 1506, 2093, 1348, 704, 1849, 2361, 477, 2611, 1595, 164, 1492, 565, 2532, 1568, 2248, 2552, 2117, 125 1397, 1618, 1224, 636, 1949, 1192, 891, 1204, 885, 2010, 374, 1794, 724, 2231, 1876, 1686, 2393, 2334, 1858, 352, 2225, 1392, 1149, 89, 940, 931, 2310, 696, 233, 1658, 151, 963, 1749, 2275, 1408, 2353, 1551, 549, 2067, 2163, 1668, 2547, 1525, 2237, 2230, 259, PSO.6002064, 688, 831, 1690, 1250, 520, 1738, 1281, 1488, 2290, 617, 1056, 936, 581, 1540, 2379, 890, 1330, 2367, 2598, 457, 602, 2493, 1556, 640, 2209; (2) System Code: 722012; UDI: 00884838059054; System Serial Number: 481, 423, 1506, 1713, 1396, 2821, 828, 383, 2942, 2308, 1271, 613, 1945, 1281, 1188, 2323, 369, 160, 124, 8… (truncated, 29148 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722015; UDI: N/A; System Serial Number: 12, 16, 2, 8, 23, 3, 13; (2) System Code: 722023; UDI: 00884838059085; System Serial Number: 49, 41, 142, 110, 12, 179, 124, 27, 98, 66, 118, 117, 138, 42, 64, 116, 127, 175, 75, 82, 83, 46, 35, 109, 146, 33, 165, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 158, 5, 86, 34, 132, 9, 108, 121, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 87, 94, 57, 125, 73, 106, 67, 16, 96, 58, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150; (3) System Code: 722035; UDI: 00884838054240; System Serial Number: 119, 126, 169, 72, 124, 161, 183, 242, 245, 246, 46, 196, 52, 236, 147, 172, 123, 74, 59, 60, 88, 30, 216, 212, 85, 21, 47, 222, 121, 131, 145, 127, 38, 187, 243, 143, 244, 125, 117, 100, 57, 247, 34, 165, 252, 101, 89, 192, 111, 128, 227, 144, 174, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 83, 53, 32, 164, 56, 40, 10, 11, 62, 265, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 151, 92, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Allura Xper FD20/15; System Code: 722058;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
System Code: 722058; UDI: 00884838059115; System Serial Number: 100, 239, 305, 259, 203, 373, 111, 38, 23, 290, 124, 274, 340, 366, 162, 186, 4, 196, 156, 285, 277, 65, 168, 56, 178, 138, 212, 249, 257, 337, 265, 109, 134, 71, 238, 190, 219, 197, 325, 24, 123, 319, 378, 61, 205, 149, 264, 167, 365, 199, 278, 215, 288, 254, 94, 304, 279, 171, 82, 85, 202, 99, 182, 22, 200, 129, 59, 172, 110, 399, 72, 332, 92, 142, 67, 106, 335, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 101, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 408, 360, 370, 400, 387, 356, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 331, 379, 418, 421, 369, 420, 397, 357, 393, 388, 108, 211, 125, 126, 301, 30, 354, 355, 159, 139, 128, 81, 58, 96, 343, 177, 115, 18, 19, 311, 386, 291, 327, 220, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; UDI-DI: 25051684007440 (Box), 15051684007443 (Pouch); Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Lot No.: A3625012, A3825055;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); UDI-DI: 25051684007983(Box), 15051684007986(Pouch); Lot No.: A2825152, A3225009;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); UDI-DI: 25051684010112(Box), 15051684010115(Pouch); Lot No.: A2825021, A2825129, A3325027, A3425027, A3525014, A3825095;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722020; UDI: N/A; System Serial Number: 4; (2) System Code: 722025; UDI: 00884838059108; System Serial Number: 6, 2, 3;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)