{ "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": "218903", "product_res_number": "Z-1812-2026", "event_date_initiated": "2026-03-03", "event_date_posted": "2026-04-13", "recall_status": "Open, Classified", "res_event_number": "98488", "product_code": "PKL", "k_numbers": [ "K212323" ], "product_description": "Instinct Plus Endoscopic Clipping Device\nREF: G58010\nRx Only, Sterile EO", "code_info": "All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104", "firm_fei_number": "1037905", "recalling_firm": "Wilson-Cook Medical Inc.", "address_1": "4900 Bethania Station Rd", "city": "Winston Salem", "state": "NC", "postal_code": "27105-1203", "additional_info_contact": "Cook Medical Customer Relations\n800-4574500", "reason_for_recall": "Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.", "root_cause_description": "Process control", "action": "On March 2, 2026, Cook Medical, issued a \"Urgent: Medical Device Recall\" Notification to affected consignees via: Fed Ex. Cook Medical asked consignees to take the following actions:\n\n1.\tExamine inventory immediately to determine if you have affected devices. Immediately cease use of the affected devices and quarantine all affected devices. \n2.\tReturn the affected devices to Cook Medical.\n3.\tPlease complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. \n4.\tThis notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. \n5.\tImmediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. \n6. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. Call the FDA at 800.FDA.1088.", "product_quantity": "713,702 units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, Brunei, Darussalam, Brazil, Canada, CANARY ISLANDS, Chile, China, Colombia, Costa Rica, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, Egypt, FINLAND, FRANCE, GERMANY, GREECE, Guatemala, Hong Kong, HUNGARY, Indonesia, India, IRELAND, ISRAEL, ITALIA, KUWAIT, LEBANON, LUXEMBOURG, MALTA, MAYOTTE, Mexico, Macao, MOROCCO, Malaysia, NEDERLAND, NORWAY, New Zealand, OMAN, PAKISTAN, Peru, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAUDI ARABIA, SLOVENIA, El Salvador, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Thailand, TURKEY, Taiwan, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ "K120814", "K212323", "K250229", "K201771", "K240274", "K161463", "K213217", "K183590", "K180325", "K153550", "K013889", "K252271", "K212669", "K183309", "K250842", "K142973", "K220157", "K230004", "K240617", "K254069", "K151802", "K213338", "K180689", "K132809", "K193424", "K232969", "K183021", "K233772", "K150067", "K192722", "K211787", "K241005", "K232450", "K221124", "K234124", "K212748", "K182556", "K102764", "K241858", "K192697", "K152001", "K251562", "K172762", "K990687", "K201808", "K101428", "K213143", "K231633", "K963160", "K253734", "K200684", "K202333", "K222503", "K172727", "K260580", "K121505", "K123601", "K122660", "K250066", "K200217", "K222146", "K023903", "K252270", "K170867" ], "registration_number": [ "3011193403", "3017178358", "3013023255", "1047843", "3013557562", "3009747810", "3016696686", "3014328942", "3010288205", "2246552", "3013460719", "3012042439", "3030446844", "3006696607", "3012494290", "3031276312", "3010273872", "3004837686", "3021023752", "3017390965", "3007829657", "3013526170", "3015142721", "3008797804", "9681260", "9611680", "3036773433", "3008720584", "3010188783", "8010047", "3014620201", "3014769442", "3010515547", "3030733800", "3013440400", "1056129", "2183446", "3009217531", "9611283", "3017210488", "9614641", "1061927", "3007695959", "1037905", "3025311469", "3005099803", "1000121056", "3035434483", "1528319", "3010432890", "3044854047", "3011050570", "3033841914", "3006621103" ], "fei_number": [ "3011193403", "1000122656", "3002806816", "3017178358", "3013023255", "1047843", "3013557562", "3009747810", "3016696686", "3014328942", "3010288205", "2246552", "3013460719", "3012042439", "3030446844", "3006696607", "3012494290", "3031276312", "3010273872", "3004837686", "3021023752", "3017390965", "3007829657", "3002807969", "3013526170", "3015142721", "3008797804", "3002807795", "3036773433", "3008720584", "3010188783", "3014620201", "3014769442", "3010515547", "3030733800", "3013440400", "2183446", "1000132436", "3009217531", "3000203000", "3003995201", "3017210488", "3007695959", "1037905", "3025311469", "3005099803", "3002806565", "1000121056", "3035434483", "3010432890", "3044854047", "3011050570", "3033841914", "3006621103" ], "device_name": "Hemostatic Metal Clip For The Gi Tract", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4400", "device_class": "2" } } ] }