{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210088", "product_res_number": "Z-0129-2025", "event_date_initiated": "2024-08-26", "event_date_posted": "2024-10-17", "recall_status": "Open, Classified", "res_event_number": "95375", "product_code": "ITJ", "product_description": "Brand Name: NOVA ORTHO-MED INC.\nProduct Name: MONARCH ROLLATOR BLUE\nModel/Catalog Number: 4329BL\nProduct Description: ROLLING WALKER MOBILITY AID", "code_info": "Lot Code: ITEM CODE: 4329BL\nSN RANGE: HT4329BLME0001 - HT4329BLPG0300\nUPC: 652308012249", "firm_fei_number": "3002329391", "recalling_firm": "Nova Ortho-Med Inc", "address_1": "1470 Beachey Pl", "city": "Carson", "state": "CA", "postal_code": "90746-4002", "additional_info_contact": "KYLE ISHIDA\n310-352-3600", "reason_for_recall": "Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.", "root_cause_description": "Device Design", "action": "On 09/25/2024, the firm sent via email an \"Urgent: Medical Device Correction\" letter to inform customers that when the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit resulting in potential fall risks.\n\nCustomers are instructed to:\nImmediately take the following steps to correct the affected units.\n1. Print the NOVA MONARCH Model 4329 Product Recall Notice and post it in your store in a visible location to customers.\n2. Check your inventory for 4329 model walkers (4329BL, 4329PL and 4329RD), isolate and hold the products until you contact NOVA ORTHO-MED INC for the next steps.\n3. Contact all customers who purchased a 4329 model to notify them of the potential issue. Schedule a time that they can come in for repair or if the customer prefers NOVA can send the replacement components directly to their residence.\n4. If you do not track serial numbers with customer purchase or do not have the customer information, please ensure that the NOVA MONARCH Model 4329 Product Recall Notice document is posted in a customer visible location.\n5. Call NOVA customer service and request the replacement component to be sent to the required location. (Part# - HCT-432915)\n6. Record the serial # s of the product that have been corrected and email them to NOVA Customer Service (info@novajoy.com) so that we can have for our records. If you prefer to call, then dial 1-800-557-6682.\n\nFor questions or assistance - Contact Information: Monday through Friday, 8:30 AM to 5:00 PM, Pacific time Time.\n\"Toll free number: 1-800-557-6682\n\"Email: info@novajoy.com", "product_quantity": "1886", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI and WY. The country of Canada.", "openfda": { "k_number": [ "K823105", "K772049", "K821404", "K833869", "K830784", "K820711", "K770608", "K770166", "K792064", "K790529", "K811485", "K833195", "K770417", "K830848" ], "device_name": "Walker, Mechanical", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3825", "device_class": "1", "registration_number": [ "", "3009096107", "1319061", "3023395601", "3031595778", "3017638267", "3043654660", "3033860076", "3010547267", "3011846517", "3005260401", "3025460026", "3012444100", "3006774806", "3029740428", "3003890514", "3034729907", "3027500264", "3010987649", "3008771621", "3008386507", "3016734231", "3015781799", "3004488394", "3021167963", "3016678414", "3016159374", "3036978609", "3010967704", "3011706862", "3035743951", "3004126239", "3014270896", "3023189540", "3007518294", "3008247697", "3008146511", "3013527364", "3035383330", "3014658541", "3009596133", "3014336266", "3012316249", "2648727", "2085249", "1651499", 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