{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193542", "product_res_number": "Z-1111-2022", "event_date_initiated": "2022-04-01", "event_date_posted": "2022-05-18", "recall_status": "Open, Classified", "res_event_number": "90132", "product_code": "FRG", "k_numbers": [ "K153025" ], "product_description": "Turbett Surgical Container, TS1500", "code_info": "UDI-DI (GTIN): 00859464007113 \n\nLot # S/N\n100036\t2017051001\n100036\t2017051004\n100036\t2017051005\n100036\t2017061018\n100036\t2017061026\n100036\t2017051000\n100036\t2017051003\n100036\t2017061021\n100036\t2017061022\n100036\t2017061020\n100036\t2017061011\n100036\t2017061012\n100001\t2016071009\n100001\t2016081005\n\n***Updated 7/11/22***\n\nLot # 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"firm_fei_number": "3012421755", "recalling_firm": "TURBETT SURGICAL, LLC", "address_1": "668b Phillips Rd Ofc 1 668b Phillips Rd", "address_2": "Ofc 1", "city": "Victor", "state": "NY", "postal_code": "14564-9741", "additional_info_contact": "Mr. Jay Schainholz\n201-788-5050", "reason_for_recall": "Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.", "root_cause_description": "Device Design", "action": "Firm notified customers on April 1, 2022 via email. Customers were instructed to immediately discontinue use of the product and quarantine the product.", "product_quantity": "232 units", "distribution_pattern": "Domestic distribution to PA, CA, and NY only.", "openfda": { "k_number": [ "K062100", "K112918", "K923408", "K133838", "K123289", "K153540", "K252823", "K180661", "K181957", "K935622", "K022978", "K241123", "K964256", "K935742", "K112591", "K071087", "K243431", "K941471", "K960204", "K844672", "K781980", "K160595", "K840342", "K960210", "K844611", "K242208", "K941645", "K943090", "K010825", "K152669", "K213907", "K171533", "K852335", "K821482", "K062704", "K962605", "K802428", "K052665", "K871202", "K781924", "K141712", "K202593", "K053389", "K831425", "K946019", "K113353", "K780294", "K220133", "K920480", "K242839", "K872754", "K152458", "K941466", "K822482", "K251347", "K233777", "K993535", "K955678", "K941468", "K821044", "K090068", "K942000", "K781981", "K842490", "K030853", "K102158", "K852203", "K151788", "K830739", 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"3017230778", "3007034244", "3004949275" ], "device_name": "Wrap, Sterilization", "medical_specialty_description": "General Hospital", "regulation_number": "880.6850", "device_class": "2" } } ] }