{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "214982", "product_res_number": "Z-2281-2025", "event_date_initiated": "2025-07-01", "event_date_posted": "2025-08-08", "recall_status": "Open, Classified", "res_event_number": "97259", "product_code": "GDY", "k_numbers": [ "K882708" ], "product_description": "Brand Name: Carefree Surgical Specialties\r\nProduct Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes\r\nModel/Catalog Number: 15508/25\r\nProduct Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes", "code_info": "Lot Code: Lot Number: 1595\nUDI Code: Not Available", "firm_fei_number": "1000221450", "recalling_firm": "Carefree Surgical Specialties", "address_1": "1123 12th Avenue", "address_2": "Suite 341", "city": "Nampa", "state": "ID", "postal_code": "83686", "additional_info_contact": "Sarah Monroe\n702-434-5058", "reason_for_recall": "Due to two issues:\r\n1. Product contamination (biological foreign matter) that could compromise sterility.\r\n2. Incorrect quantity of gauze in sterile packaging", "root_cause_description": "Process control", "action": "On 07/9/2025 and 07/14/2025, the firm send via email and certified mail an \"URGENT: MEDICAL DEVICE VOLUNTARY RECALL\" Letter to customers informing them of two product issues:\n1. the potential presence of foreign matter contamination within some units.\n2. packaging discrepancy involving the number of gauze packs contained within sealed units.\n\nCustomers are instructed to:\nFor Issue 1:\n1. Discontinue Use: Discontinue use of any unopened packages of SKU 15506/25 from Lots 1607.\n2.Report any findings: Report any findings to Carefree Surgical using the contact information below.\n3.Return or Dispose of Affected Product:\n\"Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request.\n\"Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination.\n4.Do not use, resell, or further distribute affected product.\n\nFor Issue 2:\n1.Inspect their inventory: Visually check all unopened packages of SKU 15508/25 from Lots 1595 and SKU 15505/25 from Lots 1645 and 1650 to confirm each contains five (5) sterile gauze rolls\n2.Report any discrepancies: If any units contain more than 5 rolls, please notify us immediately using the contact information below.\n3.Return or Dispose of Affected Product:\n\"Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request.\n\"Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination.\n4.Do not use, resell, or further distribute affected product.\n\nAny questions or need assistance with returns or replacements, please contact:\nAttn: Sarah Monroe Carefree Surgical Specialties, Inc. (916)663-4082 or support@carefreesurgical.com", "product_quantity": "20", "distribution_pattern": "US Nationwide distribution in the states of KY, TX, FL, NC, CO, CA, ID, WV, NY, IL, IN, IA, MI, LA, WI, MT, VA, MA, TN, CT, AL, PA, MO, NJ, AR, OH, NE, AZ, MN, MD, GA, NC, WA, VT, OK, RI, SC, NH, VT, NV, OR.", "openfda": { "k_number": [ "K823671", "K914083", "K941344", "K812707", "K872807", "K854714", "K945332", "K801768", "K771395", "K812651", "K800281", "K953059", "K830201", "K950372", "K940766", "K831913", "K832172", "K830260", "K830511", "K940763", "K882709", "K920355", "K935881", "K945335", "K953087", "K812390", "K894984", "K790050", "K972634", "K940762", "K945333", "K812018", "K830202", "K951911", "K812391", "K792471", "K953058", "K935882", "K960236", "K812554", "K882707", "K945336", "K942366", "K833626", "K812017", "K853742", "K940756", "K913302", "K953062", "K953830", "K803188", "K882708", "K884790", "K802798", "K935883", "K895372", "K913794", "K810184", "K831914", "K922054", "K950659", "K940436", "K940764", "K792630", "K781818", "K940757", "K945553", "K873391", "K812710", "K780718", "K934971", "K905135", "K813286", "K813595", "K955599", "K811632", "K913303", "K782107", "K945334", "K780871", "K941522", "K935910", "K790389", "K914082", "K920356", "K953057", "K812831", "K944879", "K945606", "K932846", "K842572", "K945866", "K953060", "K822623", "K950370", "K940767", "K941217", "K955322", "K840541", "K903358", "K872809", "K800102", "K811769", "K802982", "K864529", "K863089", "K935993", "K953088", "K950373", "K770924", "K802060" ], "registration_number": [ "1030451", "1422598", "3009114792", "1720929", "3012598266", "3004911384", "3038191347", "3015058854", "3015140199", "3026263452", "3042032212", "3010452421", "3016904853", "3008663306", "9616872", "3025413691", "1625425", "2086043", "3002468342", "1423395", "1526711", "9611959", "3007299770", "3030394731", "1223924", "2024980", "3011089435", "2032112", "3014654360", "3016970619", "1219313", "1047843", 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"3008162665", "3002806315", "3004998166", "3012660022", "3006118668", "3000206435", "1000208624", "3030455652", "3009486864", "1824619", "3014146451", "3014421917", "3007007790", "3002808274", "3012391162", "3000717925", "1000221205", "1043214", "3005034064", "3035642068", "3005112833", "3004950768", "3003076831", "3011816517", "1000136478", "1000219637", "1923569", "1417592", "3027977504", "3018269545", "3007305426", "3014926389", "1220477", "1000221450", "3045816907", "3013557562", "2648666", "3013525704", "3010175283", "3012050423", "3004555163", "2242656", "1000500301", "3004605321", "3009470597", "1526534", "3000256895", "3032597249", "3017461134", "3010131137", "3008489813", "3005951296", "3015173212", "3007082891", "3015781786", "2027062", "3011529314", "1018120", "1043572", "2245304", "3001124136", "3010220595", "3006403682", "3016170492", "3011434305", "3002722429", "3009307523", "3006897996", "2246552", "3031982537", "3010041511", "3003361112", "1000305719", "3006847952", "3004617181", "3013497020", "1000112877", "1314417", "3013602181", "1000136269", "3005595283", "3009542933", "1000125536", "3010380518", "3002806457", "3005024024", "3003040625", "3030067857", "3010656982", "3016758972", "3032960221", "3014257280", "3004777218", "2648727", "3034605486", "1000220280", "3002902735", "3013530901", "3027605727" ], "device_name": "Gauze/Sponge, Internal, X-Ray Detectable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4450", "device_class": "1" } } ] }