{ "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": "159289", "product_res_number": "Z-0410-2018", "event_date_initiated": "2017-05-22", "event_date_created": "2018-01-24", "recall_status": "Terminated", "event_date_terminated": "2018-08-30", "res_event_number": "78349", "product_code": "NEU", "k_numbers": [ "K073095" ], "product_description": "TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE", "code_info": "Lot numbers: 47883, 47910 & 47911", "firm_fei_number": "1000408433", "recalling_firm": "Somatex Medical Technologies GmbH", "address_1": "Rheinstr. 7 d 7 d rheinstr.", "city": "Teltow", "country": "Germany", "reason_for_recall": "There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.", "root_cause_description": "Device Design", "action": "On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax.", "distribution_pattern": "NY - Only one US distributor", "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" } } ] }