{ "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": "2026-10-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222960", "product_res_number": "Z-0147-2027", "event_date_initiated": "2026-09-25", "event_date_posted": "2026-10-09", "recall_status": "Open, Classified", "res_event_number": "99948", "product_code": "OHO", "product_description": "FORWARD Gunshot Wound Kit;\r\nModel: AFT-GSW;", "code_info": "Model: ATF-GSW;\nUDI-DI: 00850056748063;\nLot Numbers: IMC-00000024, IMC-00000034, IMC-00000053, IMC-00000056, IMC-00000076, IMC-00000081, IMC-00000082, IMC-00000083, IMC-00000084, IMC-00000085, IMC-00000094, IMC-00000148, IMC-00000149, IMC-00000152, IMC-00000153, IMC-00000154, IMC-00000173, IMC-00000174, IMC-00000179, IMC-00000186, IMC-00000187;", "firm_fei_number": "3030078769", "recalling_firm": "INTEGRATED MEDCRAFT LLC", "address_1": "1 Sinco Pl Unit A10 1 Sinco Pl", "address_2": "Unit A10", "city": "East Hampton", "state": "CT", "postal_code": "06424-2129", "additional_info_contact": "860-836-4692", "reason_for_recall": "Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.", "root_cause_description": "Component change control", "action": "On September 25, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers. \nActions to be taken: \n1. Immediately discontinue use of any product matching the affected item(s) and lot number(s)\nlisted in the item table above. Inspect inventory for affected product. If you have no products\nmatching the affected item(s), please fill out the acknowledge receipt form (referenced\nbelow) and indicate that you have none of these products in inventory.\n2. A copy of the Urgent Medical Device Recall from Safeguard Medical has been included\nfor reference.\n3. If you have product affected by this notice, fill out the attached Acknowledgement and\nReceipt Form and return it to quality@integratedmc.com. To ensure timely product replacement,\nplease respond within 30 days from date of this notice.\n4. If you do not have the recalled product in stock, please check the appropriate box on the form.\n5. If you have further distributed any of the items referenced in this notification, provide your customers\nwith a copy of this notification and request that they return the affected product directly to you or\ndirectly to Integrated MedCraft.", "product_quantity": "1033", "distribution_pattern": "US Nationwide distribution in the states of GA, VA.", "openfda": { "registration_number": [ "3004950768", "3009290468", "3005951296", "3005951403", "3009537407", "3008384335", "3006517436", "3008264242", "3003698793", "2435946", "3013632692", "3031184338", "3030078769", "3010374920", "3005555653", "3014694825", "3012034017", "1320537", "3042028938", "3019505063", "3001106688", "3010595009", "3014314985", "3015997711", "3011089435", "3018296902", "3015378469", "3008727544", "3013034812", "3002801783", "3008174904", "3013301147", "3007865243", "3010339057", "3034669683", "3011390857", "3012104670", "3012711490", "3031590640", "3033011342", "3049077135", "3004704697", "3043740372", "1643817", 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"device_name": "First Aid Kit Without Drug", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4014", "device_class": "1" } } ] }