{ "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": 4 } }, "results": [ { "cfres_id": "214670", "product_res_number": "Z-2293-2025", "event_date_initiated": "2025-06-05", "event_date_posted": "2025-08-12", "recall_status": "Open, Classified", "res_event_number": "97151", "product_code": "FPK", "k_numbers": [ "K883718" ], "product_description": "High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C", "code_info": "REF/UDI-DI/Lot(Expiration):\n502211002/I3116954(8/16/2028);\nHP9720E/C/00884450859889/I3116059(12/10/2027), I3127321(12/30/2027), I3137220(1/28/2028);\nHP9721E/C/00884450859896/I3116060(12/10/2027)", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 W Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "801-253-1600", "reason_for_recall": "High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.", "root_cause_description": "Process control", "action": "On 5/5/2025, recall notices were emailed to customers who were asked to do the following:\n1) Identify affected devices and quarantine, discontinue use and distribution.\nEnsure that applicable personnel within your organization are made aware of this field action.\n3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form.\n4. Return all affected devices to the firm.\n5. Complete, and return the customer response form via email to response@merit.com\n\nIf you have questions, contact the firm's customer service at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri", "product_quantity": "8040", "distribution_pattern": "US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.", "openfda": { "k_number": [ "K780673", "K810005", "K022431", "K923972", "K884156", "K834164", "K871540", "K884370", "K864395", "K950861", "K870416", "K952663", "K864692", "K873852", "K781087", "K833659", "K041178", "K770945", "K935642", "K953864", "K871085", "K874360", "K770174", "K891005", "K943992", "K950508", "K915560", "K941214", "K854629", "K870912", "K873465", "K820527", "K952243", "K912103", "K031808", "K832758", "K131517", "K921450", "K800879", "K800825", "K945184", "K883718", "K943206", "K063114", "K800877", "K833076", "K052431", "K780396", "K965208", "K950200", "K870326", "K770108", "K861626", "K772119", "K875186", "K933524", "K891009", "K063239", "K910906", "K811847", "K770596", "K771387", "K771269", "K812981" ], "registration_number": [ "3012536737", "1625425", "2024024", "3004569180", "1721504", "3016096098", "3004519921", "2523167", "1319639", "1724474", "3004050971", "3002907620", "3033589330", "3015225571", "2520313", "1928237", "3006950086", "2029015", "1222637", "1526534", "1038185", "1223004", "1649914", "3015173212", "3013820501", "1423537", "3010421104", "1000604079", "2011171", "3014246639", "1055236", "3003974574", "3011237770", "2433012", "3013319212", "2030624", "3009746061", "1921846", "3011642792", "2245270", "2032112", "3019807891", "2032227", "1422078", "3014936217", "3008692839", "9616567", "9680306", "9617594", "3008403546", "9615050", "2032098", "1721676", "1220477", "3029973819", "3007007790", "1422634", "1123137", "9612030", "1043214", "8020616", "3004111573", "1054241", "3015309643", "1644312", "8030107" ], "fei_number": [ "3003094851", "3012536737", "1625425", "2024024", "3004569180", "1000120904", "1721504", "3016096098", "2523167", "1000123180", "1000112877", "3004050971", "3005846326", "3002806934", "3002907620", "3033589330", "3015225571", "2520313", "1000160458", "3003166194", "1928237", "1000226372", "3006950086", "1038185", "1526534", "3001236905", "3010421104", "3015173212", "3013820501", "3002806476", "1000604079", "2011171", "3014246639", "3002999813", "1000117748", "1000138054", "1000112968", "3011237770", "2433012", "3013319212", "3003974574", "3002963732", "3009746061", "1921846", "3011642792", "3001665800", "2245270", "3019807891", "1000514656", "3014936217", "3000206435", "7682", "3008692839", "3003807466", "3008403546", "1000036860", "1721676", "1220477", "3029973819", "3007007790", "3003076831", "1000120555", "1043214", "3004111573", "3015309643", "3003058448" ], "device_name": "Tubing, Fluid Delivery", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }