FDA Medical devices recall · February 26, 2025

Azurion 5 M20 recall

This is an FDA Class I recall — the most serious type.

Read the official FDA notice ↗

Product

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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, 412, 443, 313, 626, 446, 426, 282, 387, 327, 350, 542, 439, 500, 321, 329, 303, 291, 620, 472, 476, 433, 493, 281, 480, 203, 442, 513, 454, 345, 304, 288, 341, 342, 430, 257, 409, 543, 366, 514, 556, 418, 197, 324, 308, 361, 217, 557, 98, 260, 33, 261, 179, 174, 548, 346, 214, 1, 3, 536, 143, 46, 429, 70, 21, 22, 7, 13, 191, 259, 343, 218, 83, 158, 156, 437, 467, 349, 374, 117, 104, 385, 369, 199, 57, 293, 518, 508, 43, 444, 5, 406, 546, 474, 498, 417, 407, 510, 284, 90, 414, 201, 130, 73, 469, 99, 100, 101, 107, 108, 449, 427, 488, 66, 115, 116, 192, 416, 144, 28, 11, 30, 68, 233, 27, 59, 298,

Distribution

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, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

States: Georgia

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-1156-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.