RecallRadar
FDA · Medical devicesClass I

Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD10 - Catalog numbers

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
96132
Recall initiated
Jan 13, 2025
Classified by FDA
Feb 20, 2025
Posted in Enforcement Report
Feb 26, 2025
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Firm location
Best, Netherlands
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
20

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jan 13, 2025. FDA classified it 38 days later, on Feb 20, 2025. This recall event covers 20 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic,… PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 59 recalls in our records.

Recalled products (20)

  • Z-1142-2025 Class I Ongoing

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    Codes / lots: Catalog numbers: (1) 722003, (2) 722010, (3) 722026; UDI-DI: (1) No UDI, (2) 00884838059030, (3) 00884838054189; Serial Numbers: (1) 285, 1634, 1349, 1153, 1154, 1472, 803, 1694, 1599, 1460, 1138, 1532, 940, 1214, 1627, 1728, 1189, 1311, 1700, 1187, 1222, 1651, 1353, 939, 1326, 445, 1223, 76986, 1023, 917, 1615, 1732, 1761, 367, 1078, 690, 1529, 1624, 997616, 1663, 1667, 928, 1449, 968, 1286, 72, 1621, 1622, 1643, 472, 1799, 1514, 1525, 1114, 1584, 1647, 1555, 1482, 1489, 1443, 1444, 1072, 1954, 1704, 1232, 1266, 1089, 1259, 1787, 1910, 1714, 1159, 1133, 1135, 1512, 892, 1084, 1031, 1067, 2936, 1411, 1271, 1807, 871, 1805, 1354, 1430, 8198, 1869, 634919, 485, 1594, 467, 1551, 390, 912, 913, 8091, 1471, 1474, 1446, 1092, 1718, 833, 1491, 1738, 1749, 1637, 1255, 1462, 1132, 1463, 1633, 1374, 1675, 691, 292, 1751, 1802, 1593, 1105, 1107, 1108, 1702, 1277, 1684, 1568, 1569, 1570, 1743,…

    Quantity: 2,274 units (459 US, 1815 OUS)

  • Z-1143-2025 Class I Ongoing

    Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

    Codes / lots: Catalog numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) No UDI, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 321, 435, 285, 384, 388, 340, 343, 399, 392, 565, 355, 367, 308, 348, 271, 530, 520, 323, 510, 49, 329, 365, 269, 270, 523, 490, 357, 346, 258, 298, 316, 485, 8095, 261, 2189, 352, 474, 497, 251, 63, 456, 360, 305, 419, 405, 489, 306, 307, 429, 447, 345, 342, 272, 531, 440, 441, 416, 116, 121, 136, 58, 561, 351, 52, CV.502, 478, 8, 55, 560, 341, 403, 25, 54, 354, 385, 26, 234, 287, 459, 469, 300, 494, 72, 76, 564, 754, 125, 519, 457, 373, 430, 499, 332, 508, 374, 85, 463, 464, 428, 500, 276, 359, 487, 538, 415, 328, 397, 366, 389, 378, 379, 371, 81, 511, 473, 209, 369, 543, 394, 507, 533, 482, 495, 333, 237, 339, 338, 467, 528, 53, 401, 325, 491 ****Serial Numbers Added 5/2/2025**** 63, 308, 8095, 8, 81, 116, 121, 136, 300, 325, 345. (2) 157, 83,…

    Quantity: 590 units (141 US, 449 OUS)

  • Z-1144-2025 Class I Ongoing

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    Codes / lots: Catalog numbers: (1) 722006, (2) 722012, (3) 722028; UDI-DI: (1) No UDI, (2) 00884838059054, (3) 00884838054202; Serial Numbers: (1) 2013, 2155, 1473, 2110, 1364, 2268, 172, 2324, 1637, 1881, 2229, 2533, 2158, 1774, 468, 813, 1477, 2051, 2462, 1352, 2562, 771, 1734, 1589, 1445, 1547, 929, 1414, 731, 2131, 635249, 2569, 1461, 914, 2097, 1890, 2281, 1896, 1762, 1764, 159, 774, 2198, 2009, 1629, 810, 1729, 2454, 1209, 1646, 1924, 1339, 2301, 1927, 1928, 1706, 1705, 2571, 2524, 1582, 972, 878, 2200, 1575, 707, 1761, 861, 2537, 722, 72246F, 1674122, 1730, 1936, 1490, 2045, 2536, 1338, 1659, 2610, 920, 1662, 1346, 1587, 1977, 2140, 664, 706, 1843, 1594, 1875, CV.381, 886, 2523, 2267, 2823014, 1583, 1585, 1520, 2126, 1856, 1941, 288, 2390, 1425, 1496, 862, 896, 2608, 1393, 2204, 2366, 2449, 2456, 2269, 2425, 2066, 1744, 1747, 1748, 1325, 1812, 2606, 641, 1728, 559, 1443, 2530, CV.271, 283,…

    Quantity: 5,029 Units (1566 US, 3463 OUS)

  • Z-1145-2025 Class I Ongoing

    Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

    Codes / lots: Catalog numbers: (1) 722008, (2) 722013; UDI-DI: (1) No UDI, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 312, 319, 516, 244, 453, 306, 378, 124, 18270, 524, 463, 197, 264, 294, 246, 320, 357, 212, 459, 472, 483, 465, 419, 38, 454, 441, 460, 369, 407, 231, 437, 105, 420, 1178, 270, 442, 521, 372, 254, 365, 390, 413, 379, 18, 239, 288, 424, 279, 481, 304, 267, 361, 415, 245, 445, 296, 487, 349, 456, 470, 386, 37, 205, 371, 416, 339, 513, 355, 337, 476, 121, 169, 327, 289, 518, 242, 93, 542, 122, 376, 543, 87, 391, 499, 253, 259, 393, 447, 495, 250, 110, 273, 31, 553, 433, 63, 398, 546, 213, 356, 408, 404, 448, 305, 475, 6001385, 425, 435, 450, 480, 370, 167, 323, 247, 525, 455, 394, 160, 350, 406, 274, 388, 283, 359, 8, 346, 335, 458, 410, 367, 266, 268, 482, 272, 385, 290, 468, 446, 46, 334 ****Serial Numbers Added 5/2/2025**** 378, 379, 516, 242, 274, 335, 367, 371,…

    Quantity: 479 units (186 US, 293 OUS)

  • Z-1146-2025 Class I Ongoing

    Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

    Codes / lots: Catalog numbers: (1) 722020, (2) 722025; UDI-DI: (1) No UDI, (2) 00884838059108; Serial Numbers: (1) 6; (2) 2, 3.

    Quantity: 3 units (2 US, 1 OUS)

  • Z-1147-2025 Class I Ongoing

    Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.

    Codes / lots: Catalog numbers: (1) 722023, (2) 722035; UDI-DI: (1) 00884838059085, (2) 00884838054240; Serial Numbers: (1) 175; (2) 208.

    Quantity: 2 units (1 US, 1 OUS)

  • Z-1148-2025 Class I Ongoing

    Allura Xper FD20/10; Catalog numbers: 722029

    Codes / lots: Catalog number: 722029; UDI-DI: 00884838054219; Serial Numbers: 71, 91, 7, 94, 62, 88, 36, 97, 21, 100, 30, 63, 60, 129, 84, 95, 126, 110, 56, 55, 57, 31, 119, 87, 93, 24, 32, 39, 34, 14, 122, 127, 45, 48, 37, 23, 44, 40, 66, 38, 98, 75, 35, 89, 82, 61, 53, 25, 58, 33, 85, 27, 46, 19, 29, 20, 92, 52, 104, 70, 65, 109, 78, 96, 26, 59, 118, 108, 49, 50, 51, 128, 107, 114, 124, 103, 106, 81, 80, 47, 123, 116, 101, 79, 120, 43, 102.

    Quantity: 87 units (22 US, 65 OUS)

  • Z-1149-2025 Class I Ongoing

    Allura Xper FD20/15; Catalog numbers: 722058

    Codes / lots: Catalog number: 722058; UDI-DI: 00884838059115; Serial Numbers: 172, 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 200, 123, 129, 149, 259, 4, 197, 134, 38, 290, 171, 56, 264, 238, 199, 61, 156, 99, 65, 59, 109, 100, 305, 319, 215, 278, 124, 196, 405, 325, 265, 378, 277, 274, 94, 182, 340, 366, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 35, 108, 32, 161, 6, 49, 89, 18, 19, 336, 392, 416, 398, 399, 412, 379, 333, 418, 385, 331, 413, 419, 400, 421, 395, 394, 408, 380, 409, 393, 369, 360, 389, 356, 357, 382, 415, 358, 411, 387, 335, 381, 370, 422, 407, 423, 397, 367, 396, 404, 420, 66, 163, 211, 214, 55, 40, 133, 114, 72, 96, 15, 9, 39, 150, 25, 81, 84, 119, 177, 268, 3, 60, 131, 377, 164, 7, 206, 101, 246, 384, 220, 261, 244, 348, 233, 106, 229, 223, 145, 136, 137, 288, 76, 86, 179, 112, 351, 130, 166, 276, 237, 45, 210, 181, 33,…

    Quantity: 302 units (69 US, 233 OUS)

  • Z-1150-2025 Class I Ongoing

    Allura Xper FD20/20; Catalog numbers: 722038

    Codes / lots: Catalog number: 722038; UDI-DI: 00884838054226; Serial Numbers: 39, 63, 42, 55, 67, 99, 60, 71, 141, 115, 7, 78, 108, 106, 167, 118, 130, 49, 119, 126, 173, 37, 38, 48, 62, 35, 137, 120, 41, 157, 96, 70, 46, 102, 153, 155, 171, 172, 163, 129, 161, 122, 156, 121, 168, 113, 169, 160, 152, 162, 164, 148, 159, 144, 111, 138, 158, 124, 140, 154, 147, 14, 166, 127, 94, 95, 90, 91, 93, 143, 92, 89, 150, 88, 34, 136, 66, 30, 58, 29, 54, 170, 28, 47, 36, 79, 98, 31, 146, 3, 123, 32, 5, 9, 27, 105, 69, 40, 75, 11, 104, 112, 50, 116, 73, 133, 110, 72, 117, 134, 135, 68, 64, 45, 109.

    Quantity: 114 units (33 US, 81 OUS)

  • Z-1151-2025 Class I Ongoing

    Allura CV20; Catalog numbers: 722031

    Codes / lots: Catalog number: 722031; UDI-DI: no UDI; Serial Numbers: 155, 42, 13, 150, 87, 154, 29, 73, 88, 48, 109, 78, 53, 17, 63, 11, 97, 138, 86, 39, 36, 152, 135, 49, 18, 15, 91, 41, 20, 64, 9, 40, 55, 23, 71, 35, 33, 32, 30, 76, 70, 25, 133, 101, 128, 173, 124, 84, 92, 166, 26, 61, 130, 89, 90, 116, 117, 110, 111, 112, 113, 177, 164, 165, 161, 162, 163, 28, 100, 174, 167, 168, 119, 50, 24, 185, 126, 149, 147, 146, 140, 79, 127, 66, 137, 65, 38, 169, 121, 122, 123, 148, 184, 62, 170, 159, 125, 131, 151, 178, 181, 158, 157, 134, 46, 136, 96, 45, 180, 47, 99, 54, 115, 31, 175, 83, 77, 94, 85,

    Quantity: 111 units (OUS ONLY)

  • Z-1152-2025 Class I Ongoing

    Allura Xper FD10C; Catalog number: 722001

    Codes / lots: Catalog number: 722001; UDI-DI: no UDI; Serial Number: 283

    Quantity: 1 unit (OUS ONLY)

  • Z-1153-2025 Class I Ongoing

    Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

    Codes / lots: Catalog numbers: (1) 722063, (2) 722221; UDI-DI: (1) 00884838085275, (2) 00884838099203; Serial Numbers: (1) 96, 122, 132, 131, 108, 84, 98, 56, 64, 101, 29, 139, 61, 75, 40, 77, 123, 154, 137, 150, 144, 135, 145, 127, 53, 121, 148, 55, 99, 143, 43, 25, 54, 151, 91, 85, 90, 86, 107, 89, 88, 44, 76, 47, 83, 93, 2, 130, 23, 73, 41, 97, 116, 117, 19, 50, 24, 149, 102, 38, 92, 72, 46, 27, 21, 78, 63, 119, 128, 28, 129, 22, 141, 69, 115, 100, 113, 106, 14, 16, 17, 70, 153, 18, 120, 105, 80, 146, 94, 104, 26, 51, 15, 59, 103, 81, 133, 48, 52, 79, 140, 3, 4, 110, 62, 30, 82, 71, 36, 37; (2) 108, 9, 54, 19, 153, 181, 6, 3, 7, 49, 115, 177, 85, 93, 171, 69, 182, 2, 60, 86, 122, 105, 44, 71, 159, 187, 8, 127, 59, 56, 126, 1, 52, 68, 145, 107, 128, 74, 97, 91, 132, 114, 130, 172, 35, 82, 134, 22, 162, 95, 67, 51, 66, 84, 61, 46, 102, 50, 53, 78, 79, 149, 99, 27, 157, 48, 32, 31, 158, 151, 141, 94,…

    Quantity: 263 units (26 US, 237 OUS)

  • Z-1154-2025 Class I Ongoing

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

    Codes / lots: Catalog numbers: (1) 722064, (2) 722222, (3) 722280(OUS ONLY); UDI-DI: (1) 00884838085282, (2) 00884838099210 (3) No UDI; Serial Numbers: (1) 267, 335, 260, 261, 209, 238, 64, 229, 218, 314, 291, 201, 270, 258, 341, 237, 35, 174, 151, 10, 82, 73, 74, 168, 125, 246, 302, 86, 81, 198, 165, 127, 274, 329, 200, 317, 179, 276, 167, 59, 58, 182, 249, 388, 112, 169, 297, 400, 458, 394, 265, 510, 502, 519, 520, 474, 441, 505, 416, 500, 387, 333, 468, 324, 504, 426, 320, 501, 413, 491, 236, 475, 311, 509, 488, 342, 389, 225, 473, 406, 457, 338, 508, 443, 513, 262, 427, 234, 469, 280, 401, 308, 304, 461, 422, 414, 310, 494, 312, 235, 322, 444, 498, 515, 449, 447, 483, 480, 448, 405, 463, 337, 470, 445, 462, 496, 247, 397, 344, 432, 503, 343, 407, 439, 517, 396, 386, 514, 454, 485, 472, 340, 476, 404, 477, 452, 442, 412, 395, 478, 479, 440, 330, 467, 492, 471, 285, 446, 385, 278, 36, 55, 94, 403,…

    Quantity: 735 units (42 US, 693 OUS)

  • Z-1155-2025 Class I Ongoing

    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

    Codes / lots: Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1) 276, 238, 264, 63, 88, 135, 261, 19, 62, 83, 171, 191, 240, 133, 100, 93, 202, 115, 46, 134, 56, 53, 151, 99, 55, 54, 157, 158, 28, 241, 234, 164, 82, 299, 32, 12, 16, 272, 72, 64, 242, 176, 95, 2, 286, 75, 145, 71, 262, 143, 36, 120, 112, 5, 6, 7, 74, 188, 253, 280, 40, 87, 102, 146, 147, 77, 122, 141, 14, 15, 4, 163, 47, 48, 3, 1, 13, 123, 86, 269, 92, 173, 174, 121, 204, 258, 126, 245, 231, 81, 199, 166, 308, 105, 124, 49, 31, 26, 108, 247, 287, 170, 61, 292, 183, 168, 197, 195, 194, 149, 138, 140, 43, 273, 21, 17, 210, 22, 37, 221, 218, 219, 114, 101, 217, 220, 111, 294, 59, 85, 160, 67, 148, 96, 30, 20, 29, 263, 196, 137, 84, 236, 198, 118, 304, 23, 172, 230, 38, 159, 187, 125, 73, 60, 203, 211, 91, 52, 226, 216, 161, 128, 44, 206, 233, 103, 243, 260, 80, 281, 154,…

    Quantity: 282 units (9 US, 273 OUS)

  • Z-1156-2025 Class I Ongoing

    Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

    Codes / lots: Catalog numbers: (1) 722228, (2) 722232(OUS ONLY), (3) 722281 (OUS ONLY); UDI-DI: (1) 00884838099234, (2) 00884838116757, (3) no UDI; Serial Numbers: (1) 522, 187, 328, 113, 205, 204, 273, 180, 61, 523, 132, 149, 48, 79, 80, 37, 481, 17, 150, 32, 159, 23, 25, 29, 431, 127, 38, 87, 47, 24, 373, 91, 399, 10, 36, 6, 49, 211, 189, 231, 123, 124, 185, 186, 198, 213, 122, 64, 20, 157, 26, 110, 403, 529, 181, 177, 524, 573, 62, 128, 153, 45, 502, 215, 92, 67, 18, 76, 504, 395, 125, 391, 178, 229, 106, 56, 12, 408, 89, 194, 60, 193, 377, 190, 383, 464, 462, 138, 94, 309, 310, 93, 114, 145, 365, 311, 611, 629, 440, 368, 590, 591, 360, 421, 195, 501, 292, 364, 490, 352, 297, 386, 525, 448, 182, 473, 404, 503, 376, 534, 486, 487, 606, 196, 280, 166, 340, 438, 220, 212, 535, 362, 555, 607, 608, 302, 489, 424, 425, 183, 402, 405, 258, 320, 384, 434, 314, 306, 325, 497, 305, 307, 338, 432, 581, 283,…

    Quantity: 632 units (77 US, 555 OUS)

  • Z-1157-2025 Class I Ongoing

    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

    Codes / lots: Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 00884838116788; Serial Numbers: (1) 26, 150, 190, 278, 69, 141, 115, 221, 148, 46, 36, 42, 98, 123, 277, 92, 103, 192, 81, 57, 70, 225, 71, 131, 234, 109, 250, 114, 41, 214, 172, 173, 163, 104, 132, 147, 208, 244, 75, 133, 151, 188, 134, 22, 23, 268, 100, 101, 138, 54, 55, 276, 275, 105, 95, 32, 112, 97, 243, 224, 45, 108, 202, 113, 127, 76, 176, 165, 271, 272, 47, 256, 187, 154, 157, 265, 238, 207, 58, 169, 231, 226, 33, 159, 40, 120, 44, 121, 31, 28, 195, 196, 197, 179, 183, 185, 50, 78, 27, 85, 39, 91, 93, 94, 96, 239, 72, 119, 137, 189, 193, 117, 118, 89, 90, 167, 102, 84, 199, 73, 178, 129, 229, 252, 86, 79, 170, 227, 145, 63, 61, 49, 200, 21, 51, 194, 38, 186, 87, 56, 161, 110, 130, 80, 171, 245, 88, 175, 198, 139, 99, 37, 264, 266, 209, 255, 140, 59, 30, 206, 60,…

    Quantity: 602 units (94 US, 508 OUS)

  • Z-1158-2025 Class I Ongoing

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    Codes / lots: Catalog numbers: (1) 722068, (2) 722226, (3) 722236; UDI-DI: (1) 00884838085367, (2) 00884838099272, (3) 00884838116801; Serial Numbers: (1) 213, 407, 85, 89, 320, 73, 308, 288, 172, 295, 110, 406, 4444, 149, 350, 243, 143, 146, 109, 413, 137, 335, 270, 319, 95, 322, 324, 374, 170, 440, 184, 64, 373, 442, 431, 136, 279, 75, 251, 400, 271, 337, 329, 232, 261, 262, 477, 564, 354, 361, 443, 104, 114, 82, 490, 196, 370, 84, 107, 528, 247, 205, 42, 117, 469, 103, 520, 446, 78, 304, 153, 323, 457, 470, 472, 150, 277, 147, 547, 462, 479, 511, 285, 487, 101, 524, 282, 76, 510, 130, 356, 494, 178, 467, 505, 239, 225, 459, 265, 275, 485, 549, 534, 365, 314, 481, 77, 552, 44, 62, 158, 535, 453, 338, 399, 215, 37, 360, 36, 408, 420, 276, 68, 359, 584, 608, 563, 556, 557, 597, 601, 605, 553, 551, 516, 612, 614, 590, 540, 591, 617, 616, 599, 602, 570, 618, 574, 560, 609, 526, 559, 603, 600, 575, 593,…

    Quantity: 1,314 units (270 US, 1044 OUS)

  • Z-1159-2025 Class I Ongoing

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    Codes / lots: Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 00884838116764; Serial Numbers: (1) 465, 437, 438, 143, 302, 559, 170, 824, 626, 697, 278, 491, 215, 720, 612, 788, 141, 644, 279, 402, 290, 524, 415, 890, 412, 166, 136, 539, 532, 538, 291, 483, 497, 576, 500, 379, 753, 677, 709, 649, 441, 305, 289, 22, 257, 258, 187, 803, 399, 613, 121, 396, 536, 537, 488, 566, 833, 456, 478, 479, 224, 309, 719, 163, 921, 296, 364, 684, 239, 383, 249, 125, 829, 513, 376, 627, 725, 728, 611, 308, 522, 862, 1007, 661, 298, 571, 654, 656, 657, 658, 292, 844, 876, 480, 481, 410, 271, 493, 327, 550, 723, 269, 185, 902, 445, 360, 232, 425, 635, 546, 748, 294, 906, 603, 645, 870, 544, 545, 523, 520, 521, 556, 557, 558, 293, 840, 598, 384, 317, 535, 359, 700, 251, 786, 240, 256, 436, 585, 31, 165, 247, 733, 204, 205, 206, 888, 923, 195, 197,…

    Quantity: 1,837 units (337 US, 1500 OUS)

  • Z-1160-2025 Class I Ongoing

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    Codes / lots: Catalog numbers: (1) 722079, (2) 722224, (3) 722234; UDI-DI: (1) 00884838085268, (2) 00884838099258, (3) 00884838116771; Serial Numbers: (1) 942, 948, 702, 703455, 703457, 703465, 703904, 45, 1316, 709, 710, 711, 713, 60, 213, 1297, 1399, 1369, 703309, 1238, 703416, 1042, 715, 703368, 703562, 703335, 465, 674, 753, 730, 703497, 804, 703413, 1142, 1410, 703329, 1090, 439, 526, 1379, 899, 327, 637, 455, 653, 593, 1018, 898, 1040, 497, 900, 1164, 334, 1063, 792, 919, 1157, 595, 250, 1246, 703532, 737, 703409, 703419, 628, 703861, 1171, 599, 320, 429, 1393, 605, 895, 540, 998, 29, 1201, 704281, 361, 769, 938, 801, 1023, 668, 1283, 703332, 423, 671, 793, 480, 937, 1048, 1137, 1424, 580, 581, 1352, 1412, 460, 1387, 923, 981, 499, 703486, 64, 703383, 703510, 708, 703334, 496, 887, 903, 422, 758, 1267, 703558, 633, 999, 1041, 703324, 374, 459, 747, 1107, 703435, 528, 50, 246, 78, 703584, 520,…

    Quantity: 4,221 units (1480 US, 2741 OUS)

  • Z-1161-2025 Class I Ongoing

    Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

    Codes / lots: Catalog numbers: (1) 722400; UDI-DI: No UDI; Serial Numbers: 531, 314, 432, 376, 496, 315, 491, 361, 389, 486, 427, 547, 330, 444, 441, 536, 479, 555, 443, 329, 440, 363, 445, 344, 286, 508, 446, 511, 135, 291, 221, 31, 143, 79, 69, 2, 160, 381, 157, 386, 174, 269, 206, 240, 151, 348, 283, 308, 188, 370, 477, 360, 319, 482, 317, 6, 199, 217, 218, 76, 364, 382, 233, 16, 258, 271, 393, 407, 184, 303, 338, 414, 321, 89, 413, 429, 502, 506, 507, 33.

    Quantity: 80 units (OUS ONLY)

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 96132
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.