{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199221", "product_res_number": "Z-1398-2023", "event_date_initiated": "2023-03-07", "event_date_posted": "2023-04-18", "recall_status": "Open, Classified", "res_event_number": "91923", "product_code": "IRP", "k_numbers": [ "K192358" ], "product_description": "REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.\n\nModels: DVTREX-U and DVTREX -L", "code_info": "UDI-DI:\nDVTREX-L: 00092237622933 \nDVTREX-U: 00092237622926\n\n\nAll Serial Numbers", "firm_fei_number": "3012316249", "recalling_firm": "Compass Health Brands (Corporate Office)", "address_1": "6753 Engle Rd", "city": "Middleburg Heights", "state": "OH", "postal_code": "44130-7934", "additional_info_contact": "Compass Health Customer Support\n800-947-1728", "reason_for_recall": "Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication", "root_cause_description": "Labeling design", "action": "Compass Health Brands issued Urgent Medical Device Recall Letter REX (Recovery Exercise Trainer) Pressure Therapy System - USER MANUAL on 3/7/23 via Email/US Mail notification to Distributors and End Users consignees and posted to the Compass Health Brands website http://www.compasshealthbrands.com.\nLetter states reason for recall, health risk and action to take:\nImmediately replace the current user manual included with the device with the attached, corrected version, and dispose of the current manual. Compass Health Brands will additionally mail you a replacement user Consumer Notification\nmanual in booklet format (which is the same format as the current user manual), if you prefer to use that as a replacement, instead.\nREQUIRED ACTION:\n1. The USER MANUAL for the REX (Recovery Exercise Trainer) Pressure Therapy System requires replacement.\n Visit https://compasshealthbrands.com/product-recall to obtain a replacement user manual, or\n Contact Compass Health Brands at (800) 947-1728 to order a replacement user manual in booklet format,\nor\n Indicate on your Reply Form (attached) that you would like a replacement user manual.\n2. Complete and return the attached Consumer Field Correction Response Form to Compass Health Brands within fifteen (15) calendar days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Compass Health Brands via email at regulatory@compasshealthbrands.com. Complete and return this form even if you do not have affected product on hand.\nIf you have transferred possession of this product to another individual/department/location, please notify them of this recall communication.\nThis voluntary Field Correction notification is being conducted with the knowledge of the United States Food and Drug Administration (FDA) in accordance with U.S. regulations. Any complaints and/or adverse events experienced with the use of this product must be reported promptly to Compass Health Brands Customer Suppor", "product_quantity": "30 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.", "openfda": { "k_number": [ "K122154", "K915638", "K231437", "K192114", "K072620", "K243320", "K222991", "K133483", "K252386", "K100656", "K212935", "K130385", "K013061", "K243206", "K161907", "K193354", "K241446", "K032505", "K112479", "K201645", "K964957", "K243572", "K250244", "K211283", "K834507", "K254200", "K212169", "K223164", "K191862", "K953516", "K860632", "K102320", "K201730", "K832920", "K242615", "K181149", "K201935", "K251622", "K251531", "K160608", "K231912", "K253076", "K852264", "K253150", "K092435", "K213533", "K260948", "K253919", "K212491", "K821920", "K113275", "K112890", "K961426", "K210967", "K071596", "K201982", "K193079", "K210240", "K192252", "K163280", "K200660", "K893950", "K781964", 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"890.5650", "device_class": "2" } } ] }