{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219967", "product_res_number": "Z-2239-2026", "event_date_initiated": "2026-04-24", "event_date_posted": "2026-05-27", "recall_status": "Open, Classified", "res_event_number": "98843", "product_code": "NEU", "k_numbers": [ "K212158" ], "product_description": "HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3", "code_info": "Lot Number: F12607207D", "firm_fei_number": "3008492462", "recalling_firm": "Devicor Medical Products Inc", "address_1": "300 E Business Way Fl 5 300 E Business Way", "address_2": "Fl 5", "city": "Cincinnati", "state": "OH", "postal_code": "45241-2384", "additional_info_contact": "Jack Cummings\n1-513-2051196", "reason_for_recall": "Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.", "root_cause_description": "Labeling mix-ups", "action": "An URGENT FIELD SAFETY RECALL was sent to customers beginning 4/24/26.\n\nAction to be taken by the user:\nAs a result of this notification, please conduct the following:\n\"Examine your inventory and identify any devices from Lot F12607207D.\n\"Immediately remove from use any devices labeled as 4010 02 15 T4 from this lot.\n\"Contact your local sales representative to coordinate next steps. The affected product (devices labeled as4010 02 15 T4 from lot F12607207D) may either:\n-Be handed to a sales representative for removal, or\n-Be disposed of at your facility in accordance with local and institutional disposal requirements.\n\"If a marker from this lot has already been implanted, review and update patient records as appropriate.\n\"Complete and return the Recall Response Form (included with this notification), even if you no longer have affected product, to confirm the receipt of this notice and completion of required actions.\nIf you have any additional questions, comments or concerns please contact our Customer Support at +1 877-926-2666. You may also email Vivian.boyd@mammotome.com.", "product_quantity": "1910 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Singapore.", "openfda": { "k_number": [ "K103417", "K102506", "K192771", "K231468", "K190689", "K093473", "K183503", "K093064", "K142198", "K040706", "K090547", "K130763", "K180443", "K042341", "K161021", "K183400", "K111692", "K251748", "K063238", "K253888", "K180621", "K121113", "K132463", "K192371", "K081085", "K230836", "K232865", "K123911", "K201863", "K253761", "K090501", "K102608", "K210600", "K100994", "K243642", "K031938", "K023450", "K222832", "K140835", "K133697", "K232615", "K040990", "K081170", "K240429", "K153189", "K170026", "K212158", "K023694", "K053518", "K073095", "K170905", "K241762", "K050384", "K062528", "K233639", "K170803", "K131654", "K182082", "K111895", "K080698", "K180061", "K011856", "K180640", "K223107", "K203097", "K193189", "K252892", "K173587", "K141722", "K152510", "K181007", "K113202", "K072219", "K063193", "K012955", "K020276", "K234149", "K151998", "K014148", "K072216", "K051421", "K143484", "K082278", "K231579", "K072913", "K141356", "K212882", "K181692", "K013413", "K130537", "K060769", "K190932", "K083006", "K210752", "K251989", "K010348", "K121964", "K152586", "K132708", "K240527", "K171767", "K221961", "K033447", "K152070", "K070436", "K090581", "K042296", "K050090", "K102768", "K240042" ], "registration_number": [ "3009656988", "3007185216", "3015225571", "3013557562", "2936485", "2135401", "3015542154", "3013176080", "3036009309", "3014680735", "3014090621", "1417485", "1220477", "3007305589", "3012345110", "9680340", "1018233", "1319660", "1054811", "1020279", "3018024590", "2032338", "1835568", "3011162972", "3006950086", "3033536844", "3011683674", "3013875526", "3007055279", "3033589330", "1644312", "3005160949", "3002907620", "2183744", "3004904811", "3010813819", "1000393132", "3020733550", "3021179744", "3015309643", "2022435", "3019807891", "3006082230", "3014579161", "3015924373", "3035366890", "1211566", "3010339638", "1724474", "3008706707", "1721504", "3007200016", "3014967969", "1450662", "3009609358", "3038503932", "1064858", "3015207155", "2951215", "9617429", "1000486410", "1226183", "3009039068", "3030733800", "1647149", "3009077524", "1222780", "1625425", "3026851515", "1037905", "3014653199", "1222140", "3013012623", "3007738736", "1928237", "3015439135", "3009192245", "3030927217", "3009905888", "3011245468", "3012536737", "3009649442", "3000126629", "3021008900", "3018094310", "3005636544", "3004111573", "3008992312", "3010083866", "2029275", "3016678045", "3004636440", "1721676", "3006981798", "1825034", "3008627763", "2020394", "3008492462", "3008236846", "3012644426", "3013649990", "3007366790", "2134494" ], "fei_number": [ "3009656988", "1000114185", "3007185216", "3015225571", "3002619738", "3013557562", "1000136478", "2936485", "3002807584", "3015542154", "3013176080", "3036009309", "3014680735", "3014090621", "1417485", "1220477", "3007305589", "3012345110", "1018233", "1000306139", "1020279", "1000306431", "3018024590", "3011162972", "3006950086", "3033536844", "3011683674", "3013875526", "3007055279", "3033589330", "1000117748", "3005160949", "3002907620", "2183744", "3004904811", "3010813819", "1000393132", "1000221492", "3003094851", "3020733550", "3021179744", "3015309643", "2022435", "3019807891", "3006082230", "3014579161", "3015924373", "3035366890", "1211566", "3010339638", "3008706707", "1721504", "1000434163", "3007200016", "3014967969", "1450662", "3009609358", "3038503932", "3003367650", "3015207155", "1000486410", "3009039068", "3030733800", "3009077524", "1625425", "3026851515", "1037905", "3014653199", "3013012623", "3001237677", "3007738736", "1928237", "3003295907", "3015439135", "3009192245", "3030927217", "3009905888", "3008397795", "3011245468", "3012536737", "1000120743", "3009649442", "1000121130", "3000126629", "3021008900", "3018094310", "3005636544", "3004111573", "3002757549", "3008992312", "3010083866", "3016678045", "3004636440", "1721676", "3006981798", "1825034", "3008627763", "2020394", "3008492462", "3008236846", "3012644426", "3013649990", "3007282753" ], "device_name": "Marker, Radiographic, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }