{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216329", "product_res_number": "Z-0316-2026", "event_date_initiated": "2025-10-01", "event_date_posted": "2025-10-24", "recall_status": "Open, Classified", "res_event_number": "97680", "product_code": "NEU", "k_numbers": [ "K232865" ], "product_description": "Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07.\n\nProduct Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.", "code_info": "Model Number. MS2-17-1-07. GTIN:15060391210459. UDI: 15060391210459241227-01;15060391210459250212-02; 15060391210459250324-03; 15060391210459250415-06; 15060391210459250523-11; 15060391210459250612-51\n\nBatch Numbers: 250212-02, 250324-03, 250415-06, 250523-11, 241227-01, 250612-51.", "firm_fei_number": "3012644426", "recalling_firm": "ENDOMAGNETICS LTD", "address_1": "St. Johns Innovation Park Cowley Road", "city": "Cambridge", "country": "United Kingdom", "reason_for_recall": "Potential for contamination with cotton fibers.", "root_cause_description": "Process control", "action": "Endomagnetics, Ltd notified consignees on about 10/01/2025 via certified mail and email through 3rd party IQVIA. Consignees were instructed to examine their inventory and cease use of those units, quarantine any affected units, complete and return the response form, forward the notification to all affected personnel and customers if further distributed, and post a copy of the notice in a visible area for awareness and keep a copy for your records.", "product_quantity": "1,760 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL, GA, IA, ID, IN, KY, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, TX, WA and the country of Canada.", "openfda": { "k_number": [ "K170905", "K023694", "K170803", "K143484", "K141722", "K221961", "K100994", "K073095", "K181007", "K240527", "K051421", "K182082", "K240429", "K033447", "K251748", "K133697", "K253888", "K072216", "K241762", "K141356", "K063238", "K040990", "K011856", "K113202", "K013413", "K102768", "K090547", "K121113", "K082278", "K102506", "K090501", "K053518", "K062528", "K234149", "K083006", "K253761", "K103417", "K161021", "K153189", "K093064", "K123911", "K170026", "K081170", "K222832", "K171767", "K193189", "K231468", "K190932", "K014148", "K183503", "K181692", "K023450", "K232865", "K152510", "K151998", "K252892", "K042296", "K010348", "K232615", "K132708", "K050090", "K070436", "K080698", "K201863", "K212158", "K090581", "K173587", "K183400", "K233639", "K042341", "K072219", "K180640", "K192771", "K111692", "K180621", "K192371", "K020276", "K231579", "K130537", "K152070", "K210600", "K081085", "K251989", "K152586", "K060769", "K180061", "K102608", "K180443", "K121964", "K210752", "K132463", "K223107", "K140835", "K212882", "K050384", "K072913", "K243642", "K190689", "K142198", "K130763", "K093473", "K230836", "K012955", "K031938", "K063193", "K040706", "K240042", "K203097", "K131654", "K111895" ], "registration_number": [ "3030927217", "3030733800", "1220477", "3009077524", "1417485", "3018094310", "3015542154", "2951215", "1450662", "1724474", "3009039068", "3007200016", "3012345110", "2936485", "3010813819", "3013557562", "2032338", "1835568", "3002907620", "1928237", "1211566", "3004111573", "3013012623", "3015924373", "1054811", "3011683674", "3020733550", "3018024590", "1721676", "3011162972", "3012644426", "3033589330", "3015207155", "3026851515", "1000393132", "2135401", "1644312", "3021179744", "2022435", "3007055279", "3007738736", "3021008900", "3019807891", "3015309643", "3000126629", "1037905", "3008627763", "3012536737", "3015439135", "1064858", "2134494", "3013176080", "1000486410", "3008236846", "1625425", "3014653199", "3036009309", "1222780", "3014680735", "9680340", "1647149", "2183744", "3005636544", "3007305589", "1721504", "3006082230", "3004904811", "3006950086", "3013649990", "3009649442", "3014967969", "3007185216", "1825034", "3038503932", "2029275", "2020394", "3014579161", "3008706707", "3005160949", "3010083866", "1319660", "3011245468", "1020279", "3007366790", "3010339638", "3014090621", "1018233", "3016678045", "3006981798", "3008492462", "9617429", "1222140", "3015225571", "1226183", "3033536844", "3009656988", "3009609358", "3035366890", "3008992312", "3009192245", "3009905888" ], "fei_number": [ "3030927217", "3030733800", "1220477", "3009077524", "1417485", "3018094310", "3001237677", "3015542154", "3007282753", "1000121130", "1450662", "3002757549", "3009039068", "3007200016", "1000306431", "3012345110", "2936485", "3010813819", "3013557562", "1000117748", "3002907620", "1928237", "3002807584", "1211566", "3004111573", "3013012623", "1000434163", "3015924373", "3003295907", "3011683674", "3020733550", "3018024590", "1721676", "1000221492", "3011162972", "3012644426", "3002619738", "3033589330", "3015207155", "3026851515", "1000393132", "3021179744", "2022435", "3007055279", "1000120743", "3007738736", "3021008900", "3019807891", "3015309643", "3008397795", "3000126629", "1037905", "3008627763", "3003094851", "3012536737", "3015439135", "1000306139", "3013176080", "1000486410", "3008236846", "1625425", "3014653199", "3036009309", "1000136478", "3014680735", "3005636544", "2183744", "3007305589", "1721504", "3003367650", "1000114185", "3006082230", "3004904811", "3006950086", "3013649990", "3009649442", "3014967969", "3007185216", "1825034", "3038503932", "2020394", "3014579161", "3008706707", "3005160949", "3010083866", "3011245468", "1020279", "3010339638", "3014090621", "1018233", "3016678045", "3006981798", "3008492462", "3015225571", "3033536844", "3009656988", "3009609358", "3035366890", "3008992312", "3009192245", "3009905888" ], "device_name": "Marker, Radiographic, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }