--- title: "Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with t... — FDA record Z-1608-2026 | Is It on Recall" description: "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U" url: https://isitonrecall.com/recall/fda-device-z-1608-2026-brand-name-i-t-s-pelvic-reconstruction-system-prs-rx-prs-phoenix-with-the-below-descriptions-and-cor/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding ... — FDA record Z-1608-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jan 23, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-... - **Reason**: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). - **Classification**: Class II - **Recalling firm**: I.T.S. GmbH - **Quantity**: 46,637 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1608-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1608-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 1. Article Number (Lot Numbers): 21218-16 (679/112166, 679/122229, 679/122230, 679/122304), 21219-16 (679/012441, 679/062456, 679/0624561, 679/112167, 679/122228). 2. Article Number (Lot Numbers): 21218-14(679/032417, 679/102231, 679/112158, 679/112164, 679/122231), 21219-14 (679/012505, 679/112159, 679/112165, 679/122227, 679/122305). 3. Article Number (Lot Numbers): 21216-10 (679/032501, 679/062453, 679/072276, 679/072510, 679/092203, 679/092401, 679/112168, 679/112409, 679/122270), 21216-12 (679/032503, 679/062344, 679/062454, 679/072277, 679/092204, 679/112170, 679/112413, 679/122271), 21217-10 (679/032502, 679/062346, 679/072278, 679/092402, 679/092404, 679/102216, 679/112169, 679/112423), 21217-12 (679/022238, 679/062345, 679/072513, 679/092403, 679/112171, 679/122407, 679/122426). 4. Article Number (Lot Numbers): 30591-36 (18/922090), 30591-70 (18/231539, 18/775273), 30591-75 (18/751307), 30591-80 (18/777295), 30591-85 (18/301308), 30591-90 (18/311309). 5. Article Number (Lot Numbers): 37422-12-N (18/145897, 18/461842), 37422-14-N (18/215281, 679/032001, 679/062320, 679/092355, 679/122326), 37422-16-N (679/052229, 679/052307, 679/102214, 679/102306, 679/122329), 37422-18-N (18/240520, 18/452529, 18/473354, 679/052316, 679/102215, 679/102337, 679/122330), 37422-20-N (679/0323147, 679/072306, 679/102211, 679/102338, 679/122331), 37422-22-N (18/092876, 18/543636, 679/012406, 679/062361, 679/072312, 679/102212, 679/102348), 37422-24-N (679/012407, 679/052333, 679/072313, 679/102349), 37422-26-N (679/012435, 679/062316, 679/072322, 679/102353), 37422-28-N (18/192499, 679/012422, 679/032211, 679/062317, 679/062323, 679/072323, 679/102361), 37422-30-N (18/217289, 679/012436, 679/032212, 679/0323142, 679/072324, 679/102354), 37422-32-N (18/218290, 679/012437, 679/052335, 679/052337, 679/072329, 679/112306), 37422-34-N (18/031830, 18/219291, 679/012446, 679/062337, 679/062341, 679/072330, 679/112318), 37422-36-N (18/220292, 18/240540, 18/734742, 679/012447, 679/042317, 679/042321, 679/062003, 679/072334, 679/102361), 37422-38-N (18/105881, 18/221293, 18/362296, 18/412482, 679/012243, 679/022407, 679/052331, 679/052334, 679/072349, 679/112323), 37422-40-N (18/052830, 18/222294, 18/240538, 18/493069, 18/736744, 679/022401, 679/032310, 679/042302, 679/072354, 679/112329), 37422-42-N (18/053831, 18/081544, 18/223295, 18/364298, 18/733745, 679/022402, 679/062371, 679/082304, 679/112330), 37422-44-N (18/054832, 18/224296, 18/365299, 18/737746, 18/781832, 679/022412, 679/042331, 679/042345, 679/082314, 679/112335), 37422-46-N (18/052578, 18/225314, 18/366300, 18/738747, 679/022419, 679/042313, 679/042318, 679/082319, 679/112336), 37422-48-N (18/056834, 18/226315, 679/022423, 679/052324, 679/052328, 679/072316, 679/092314, 679/112337), 37422-50-N (18/227316, 18/740748, 679/022436, 679/042336, 679/052314, 679/092342, 679/112338), 37422-55-N (18/113882, 18/368302, 679/032215, 679/052336, 679/062309, 679/092322, 679/112324), 37422-60-N (18/229318, 18/240517, 18/927095, 28/33034, 679/032403, 679/062349, 679/062351, 679/092325, 679/122307), 37422-65-N (18/118884, 18/230319, 18/271754, 18/743749, 18/761192, 28/35846, 679/032216, 679/072303, 679/092326, 679/122308), 37422-70-N (679/102213, 18/744750, 18/893916, 679/062368, 679/092338, 679/102213, 679/122309), 37422-75-N (18/122888, 18/231839, 679/072304, 679/122306), 37422-80-N (679/122254, 18/124887, 679/062352, 679/122320), 37422-85-N (18/056936, 18/271837, 679/012256, 679/092339), 37422-90-N (18/050600, 18/321273, 679/092340), 37422-95-N (18/130891, 679/092341), 37422-100-N (18/132892, 18/341607, 679/102403), 37422-105-N (679/102404), 37422-110-N (18/136894, 18/371843, 679/092337), 37422-115-N (18/138895, 18/391845, 679/012262), 37422-120-N (18/140896, 679/092349), 37592-18 (679/072351), 37592-20 (18/831792, 18/252862), 37592-22 (18/172773, 679/072356), 37592-24 (679/082301), 37592-26 (18/182774, 679/082303), 37592-28 (679/012140, 679/082310), 37592-30 (18/112775, 679/082317), 37592-32 (679/082312), 37592-34 (18/192863, 679/082313), 37592-36 (679/082318), 37592-38 (679/092308), 37592-40 (679/052116, 679/072314), 37592-42 (679/092310), 37592-46 (18/092772, 679/092312), 37592-48 (679/052118, 679/092313), 37592-50 (679/092343), 37592-54 (679/072315), 37592-56 (18/721587), 37592-58 (679/092334), 37592-60 (679/042213, 679/072325, 679/092345), 37592-65 (679/072331), 37592-70 (679/042289, 679/072340, 679/092353), 37592-75 (18/429442, 679/092351), 37592-80 (679/052204, 679/072341, 679/092335), 37592-85 (679/042291, 679/072342, 679/092354), 37592-90 (679/042292, 679/092352). 6. Article Number (Lot Numbers): 31851-60 (18/373463, 18/813133), 31851-65 (18/374464), 31851-70 (18/375465), 31851-75 (18/376467), 31851-80 (18/125212, 18/377468, 18/431563, 18/867967), 31851-85 (18/044945, 18/378469, 18/441564), 31851-90 (18/045946, 18/343266, 18/451565), 31851-95 (18/046947, 18/128224, 18/379470, 18/461566), 31851-100 (18/129225, 18/471567, 18/821469, 18/860968), 31851-105 (18/380471), 31851-110 (18/901298, 18/387472), 31851-115 (18/381473, 18/048949), 31851-120 (18/049950, 18/133227, 18/511577, 18/862970), 31851-125 (18/050951, 18/347474, 18/521578), 31851-130 (18/051952, 18/344368, 18/531579), 31851-135 (18/382475, 18/541580), 31851-140 (18/052953, 18/551777, 18/863971), 31851-145 (18/054954, 18/137229, 18/345351, 18/561779), 31851-150 (18/138260, 18/191042, 18/346352, 18/571780, 18/797898), 31851-155 (18/201043, 18/384476), 31851-160 (18/062955, 18/799900, 18/866972), 31851-165 (18/063956, 18/211045, 18/385477), 31851-170 (18/141230, 18/221046, 18/348353), 31851-175 (18/064957, 18/142263, 18/386398), 31851-180 (18/065958, 18/143264, 18/388399), 31851-185 (18/389400), 31851-190 (18/066959, 18/390401), 31851-195 (18/067960, 18/391478), 31851-200 (18/013266, 18/392479), 31854-60 (18/393482), 31854-65 (18/394499, 18/691605), 31854-70 (18/070983, 18/395500), 31854-75 (18/071984, 18/396501), 31854-80 (18/072985, 18/397502, 18/731608, 18/871960), 31854-85 (18/149247, 18/240529, 18/741609, 18/872961), 31854-90 (18/150280, 18/398503, 18/751610, 18/873962), 31854-95 (18/399504, 18/761611, 18/874963), 31854-100 (18/400505, 18/771612, 18/868964), 31854-105 (18/401506), 31854-110 (18/073986, 18/869965), 31854-115 (18/074987, 18/402507, 18/801615), 31854-120 (18/403508, 18/870966), 31854-125 (18/404509, 18/821617), 31854-130 (18/075988, 18/405366, 18/831618), 31854-135 (18/076989, 18/406510), 31854-140 (18/407369, 18/851693), 31854-145 (18/408370, 18/861706), 31854-150 (18/160285, 18/409371, 18/871704), 31854-155 (18/410511), 31854-160 (18/1622951, 18/411372, 18/862761, 18/891708), 31854-165 (18/163286, 18/412512), 31854-170 (18/164296, 18/413513), 31854-175 (18/079992, 18/414514), 31854-180 (18/080993, 18/415515), 31854-185 (18/081994, 18/416373, 18/808929), 31854-190 (18/082995), 31854-195 (18/083996, 18/961715), 31854-200 (18/084997, 18/417516). 7. Article Number (Lot Numbers): 32351-10 (18/019937, 18/208200, 18/731287, 679/052205, 679/122249), 32351-12 (18/020938, 18/209211, 18/741316, 679/062203, 679/102243), 32351-14 (18/210212, 18/501230, 18/761312, 679/012324, 679/032524, 679/042419, 679/062225, 679/082501, 679/122207), 32351-16 (18/022940, 18/211212, 18/771313, 679/022311, 679/022533, 679/032525, 679/042421, 679/072201, 679/092501, 679/122204), 32351-18 (18/212213, 18/781322, 18/801041, 679/022312, 679/032526, 679/042427, 679/072202, 679/102501, 679/122208), 32351-20 (18/024942, 18/181975, 18/213214, 18/791323, 679/032527, 679/042428, 679/102502, 679/112225), 32351-22 (18/025943, 18/214215, 18/801324, 18/8013241, 18/821061, 679/052219, 679/112235), 32351-24 (18/026988, 18/215216, 18/811325, 18/8113251, 18/831062, 679/052206, 679/102239), 32351-26 (18/027989, 18/216217, 18/821326, 18/841063, 679/052202, 679/052407, 679/112236), 32351-28 (18/028990, 18/217218, 18/8313271, 679/052220, 679/102235), 32351-30 (18/029991, 18/218219, 18/841314, 679/062205, 679/122260), 32351-32 (18/219220, 18/301035, 18/851315, 18/8513151, 679/012303, 679/052203), 32351-34 (18/220221, 18/311041, 18/861328, 18/961089, 679/052243, 679/112229), 32351-36 (18/230222, 18/411090, 679/052221, 679/112241), 32351-38 (18/131369, 18/1313691, 18/221226, 18/321091, 26/F66144, 679/052207, 679/102247), 32351-40 (18/222223, 18/331092, 679/052208, 679/122243), 32351-42 (18/223224, 18/341093, 18/871329, 18/8713291, 679/112214), 32351-44 (18/351094, 18/881330, 18/8813301, 18/921138, 679/052209, 679/112211), 32351-46 (18/225227, 18/361095, 18/891331, 18/8913311, 18/931313, 679/042217, 679/112215), 32351-48 (18/226228, 18/371096, 679/052210, 679/122244), 32351-50 (18/227229, 18/381097, 18/941314, 679/012304, 679/052211), 32351-55 (18/391098, 18/901332, 18/951142, 18/951315, 679/042218, 679/112237), 32351-60 (18/229231, 18/401099, 18/961316, 679/042283, 679/122250), 32351-65 (18/981144, 679/022326, 679/042284), 32351-70 (18/236233), 32351-75 (18/237234, 679/022328), 32351-80 (18/461103, 679/042286), 32351-85 (18/431104), 32352-16 (679/022406, 679/072207, 679/122427), 32352-18 (679/012501, 679/022344, 679/052182), 32352-20 (18/670753, 679/012453, 679/012504, 679/022345, 679/052184, 679/052311), 32352-22 (18/237340, 679/012454, 679/022346, 679/022506, 679/062101, 679/072208, 679/122003), 32352-24 (18/238437, 18/672755, 679/022404, 679/032379, 679/032528, 679/052312, 679/062102, 679/072209, 679/122424), 32352-26 (18/239357, 18/673756, 679/022352, 679/022405, 679/032512, 679/052313, 679/072210, 679/122416), 32352-28 (18/240358, 18/674757, 679/022411, 679/032267, 679/032324, 679/032529, 679/052303, 679/072211, 679/122418), 32352-30 (18/675758, 18/950241, 679/022417, 679/022513, 679/032325, 679/052304, 679/072213, 679/102414, 679/102513), 32352-32 (18/242360, 18/676759, 679/022418, 679/032323, 679/032530, 679/052305, 679/072214, 679/122421), 32352-34 (18/243361, 18/677760, 679/022426, 679/022514, 679/032326, 679/052301, 679/072280, 679/102401), 32352-36 (18/244362, 18/678761, 679/032327, 679/032531, 679/042274, 679/052302, 679/072282, 679/122422), 32352-38 (18/245363, 18/679762, 679/022428, 679/0323112, 679/032392, 679/032513, 679/072283, 679/112502, 679/122413), 32352-40 (18/246364, 18/680763, 679/012506, 679/022438, 679/032268, 679/032375, 679/042342, 679/072112, 679/072285, 679/112505, 679/122419), 32352-42 (18/247365, 18/681764, 679/012507, 679/012508, 679/032347, 679/042343, 679/062246), 32352-44 (18/248366, 18/682765, 679/012217, 679/012503, 679/032339, 679/062247), 32352-46 (18/249367, 18/683766, 18/819818, 679/012218, 679/022526, 679/032371, 679/042332, 679/062249, 679/072294, 679/102402, 679/122501), 32352-48 (18/250368, 679/022444, 679/022505, 679/032372, 679/062251, 679/102180), 32352-50 (18/251369, 18/685768, 679/012509, 679/022452, 679/032364, 679/042329, 679/062253, 679/072295, 679/112434), 32352-55 (18/252370, 18/686769, 679/022504, 679/032376, 679/062255, 679/072296, 679/072297, 679/122401, 679/122504), 32352-60 (18/253438, 18/687770, 679/012222, 679/022527, 679/032328, 679/062257, 679/072298), 32352-65 (18/254460, 18/688798, 679/022457, 679/022520, 679/032343, 679/062259), 32352-70 (18/255371, 18/823821, 679/032344, 679/032408, 679/042316, 679/062261, 679/082201), 32352-75 (18/256429, 679/022522, 679/032398, 679/032399, 679/032409, 679/062263), 32352-80 (18/257430, 679/022523, 679/0323104, 679/0323107, 679/032410, 679/062265), 32352-85 (679/0323109, 679/0323113, 679/062267), 32352-90 (679/0323138, 679/0323141, 679/062268), 32352-95 (679/0323146, 679/0323148, 679/062271), 32352-100 (679/012230, 679/032266, 679/032411, 679/042301, 679/062273), 32352-105 (679/032412, 679/032509, 679/042311, 679/062275), 32352-110 (679/032413, 679/032521, 679/042312, 679/062277), 32352-115 (679/032418, 679/042319, 679/062279), 32352-120 (679/032419, 679/042320, 679/062281), 32455-18 (18/371232), 32455-20 (18/892124), 32455-22 (18/391234, 18/434375, 679/032395), 32455-24 (18/401235, 18/435376, 26/F62579, 679/032387, 679/032396, 679/092502), 32455-26 (18/411236, 18/436377, 679/032397, 679/092503), 32455-28 (18... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1608-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Apr 1, 2026 - **Recall initiation date**: Jan 23, 2026 - **Center classification date**: Mar 20, 2026 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1608-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [I.T.S. GmbH records](https://isitonrecall.com/brand/i-t-s-gmbh/)