{ "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": "219273", "product_res_number": "Z-1944-2026", "event_date_initiated": "2026-03-09", "event_date_posted": "2026-04-24", "recall_status": "Open, Classified", "res_event_number": "98632", "product_code": "NNI", "product_description": "VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS", "code_info": "UDI-DI: 08052478981055;\nLot Number: 2024-09", "firm_fei_number": "1000391282", "recalling_firm": "Milestone S.R.L.", "address_1": "Via Fatebenefratelli 1/5 1/5 via fatebenefratelli", "city": "Sorisole", "country": "Italy", "reason_for_recall": "There is a possibility of reagent leakage from the specimen container.", "root_cause_description": "Under Investigation by firm", "action": "A RECALL Field Safety Note (FSN) Field Safety Corrective Action (FSCA) dated 3/9/26 was sent to customers.\n\nAdvice on immediate action to take\nContact immediately your distributor.\nIf the LOT/BATCH number reported on the box is the same as the reported above:\n1. do not use, neither distribute, REF 68409SS VACUUM BAG SU LARGE;\n2. contact immediately your distributor, or Milestone S.P.A..\nWe warn you to dispose of the unused container present in your stock and not used yet.\nMilestone will replace them with new ones.\n\nTransmit of this Field Safety Notice:\nThis notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.\n\nPlease transfer this notice to other organizations on which this action has an impact.\nPlease maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.\n\nPlease report all device-related incidents to Milestone S.P.A. (at the e-mail address reported below), distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback.\n\nIf you have further questions, do not hesitate to contact us: regulatory@milestonesrl.com", "product_quantity": "61600 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.", "openfda": { "registration_number": [ "3010790521", "3021013122", "3013557562", "1060680", "3010162618", "3010188738", "3027266036", "3008648418", "2182202", "3012763559", "3016837106", "3005739529", "3007478714", "3006210673", "3019315696", "3016008117", "2016673", "3008770712", "3010583458", "2024311", "9680168", "3006636962", "3026664926", "1648571", "3009520931", "3017231740", "2433012", "1423537", "3006115103", "3006673317", "2024674", "3010399422", "3029894046", "1055236", "3004527595", 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