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.
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.