{ "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": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222845", "product_res_number": "Z-0187-2027", "event_date_initiated": "2026-08-27", "event_date_posted": "2026-10-15", "recall_status": "Open, Classified", "res_event_number": "99901", "product_code": "NEU", "k_numbers": [ "K252892" ], "product_description": "Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 \nContents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO", "code_info": "MDS05A-01-Lot: H3515477/UDI:00884450392850;\nMDS05C-01 - Lot: H3507786/UDI:00884450392874;\nMDS10C-01 - Lot:H3507794/UDI:00884450392911", "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": "Merit Customer Service\n800-356-3748", "reason_for_recall": "The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.", "root_cause_description": "Process control", "action": "On August 27, 2026, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via FedEx. Merit ask consignees to take the following actions: \n\n1. Immediately determine if any of the devices identified in the attached Customer ResponseForm (CRF) are within your facility.\n2. Immediately discontinue the use of the affected lots of the SCOUT MD Delivery System.\n3. Ensure that applicable personnel within your organization are made aware of this recall.\n4. 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 CRF. \n5. Please fill out, scan and email the completed CRF to Customer Service at RESPONSE@merit.com within 7 business days. All affected products shipped to you must be accounted for on the CRF.\n6. Immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.", "distribution_pattern": "US: AZ, CA, FL, IN, LA, NV, RI\nOUS: None", "openfda": { "k_number": [ "K063238", "K234149", "K090581", "K153189", "K102768", "K072216", "K121113", "K141356", "K123911", "K240527", "K233639", "K190932", "K132463", "K253888", "K051421", "K251748", "K081170", "K183503", "K171767", "K253761", "K212882", "K130537", "K222832", "K012955", "K042341", "K031938", "K093473", "K102608", "K181007", "K023694", "K090501", "K090547", "K182082", "K111895", "K180061", "K133697", "K180640", "K080698", "K212158", "K040706", "K102506", "K180443", "K131654", "K201863", "K023450", "K210600", "K063193", "K020276", "K170026", "K210752", "K141722", "K143484", "K240429", "K170803", "K231579", "K230836", "K152510", "K231468", "K170905", "K072219", "K251989", "K132708", "K192771", "K192371", "K232865", "K011856", "K014148", "K152070", "K140835", "K183400", "K083006", "K142198", "K193189", "K060769", "K070436", "K240042", "K010348", "K243642", "K053518", "K151998", "K252892", "K241762", "K072913", "K062528", "K152586", "K161021", "K180621", "K040990", "K203097", "K050090", "K130763", "K013413", "K111692", "K103417", "K050384", "K093064", "K081085", "K042296", "K190689", "K121964", "K033447", "K223107", "K073095", "K082278", "K113202", "K173587", "K100994", "K232615", "K221961", "K181692" ], "registration_number": [ "1625425", "2951215", "3015924373", "3021179744", "9680340", "3006981798", "3007185216", "3007366790", "3012345110", "3013176080", "2029275", "1037905", "3019807891", "3014090621", "3011683674", "1054811", "3018024590", "3011162972", "1319660", "3004111573", "3033589330", "1222140", "3008992312", "3038503932", "3015309643", "1020279", "3009649442", "3004904811", "3000126629", "3035366890", "3026851515", "1064858", "1450662", "2032338", "3008236846", "2022435", "3013012623", "3020733550", "3007305589", "3009609358", "3015439135", "1721504", "1211566", "3018094310", "3002907620", "1835568", "3014967969", "3016678045", "3010813819", "1928237", "3030733800", "3005160949", "3014680735", "3008706707", "1825034", "3030927217", "3006950086", "3011883032", "1000486410", "3015225571", "1018233", "3006082230", "3009039068", "1644312", "3009077524", "1222780", "3014579161", "2020394", "9617429", "3013875526", "1647149", "1000393132", "3009192245", "3015542154", "2183744", "3015207155", "3007055279", "1417485", "1226183", "3008627763", "3012536737", "2936485", "3012644426", "3013557562", "3008492462", "3009656988", "3010339638", "3021008900", "3011245468", "2134494", "1220477", "3009905888", "2135401", "3004636440", "3013649990", "3007738736", "1724474", "3036009309", "3014653199", "3005636544", "3007200016", "3033536844", "1721676" ], "fei_number": [ "3002757549", "1625425", "3015924373", "3021179744", "3006981798", "3007185216", "3012345110", "3013176080", "1037905", "3019807891", "3014090621", "3011683674", "3018024590", "3011162972", "3004111573", "3002807584", "3003094851", "3033589330", "1000306139", "3008992312", "1000114185", "3038503932", "3015309643", "1020279", "3009649442", "3004904811", "3000126629", "3035366890", "3026851515", "1000306431", "3001237677", "1000117748", "1450662", "1000221492", "3008236846", "2022435", "3013012623", "3020733550", "3007305589", "1000121130", "3009609358", "3007282753", "3015439135", "1721504", "1211566", "3018094310", "3002907620", "3014967969", "3016678045", "3003295907", "3010813819", "1928237", "3030733800", "3005160949", "3014680735", "3008706707", "1825034", "3030927217", "1000120743", "3006950086", "3011883032", "1000486410", "3015225571", "1000136478", "1018233", "3006082230", "3009039068", "3009077524", "3008397795", "3014579161", "2020394", "3013875526", "1000393132", "3009192245", "3015542154", "2183744", "3015207155", "3007055279", "1417485", "1000434163", "3008627763", "3003367650", "3012536737", "3012644426", "3013557562", "2936485", "3008492462", "3002619738", "3009656988", "3010339638", "3021008900", "3011245468", "1220477", "3009905888", "3004636440", "3013649990", "3007738736", "3036009309", "3014653199", "3005636544", "3007200016", "3033536844", "1721676" ], "device_name": "Marker, Radiographic, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }