{"recall":{"id":"fda-device-99760","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"New York Embroidery Studio, Inc. recalls New York Embroidery Studio Trinity Non-Surgical Isolation Gown","firm":"New York Embroidery Studio, Inc.","date":"2026-07-31","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.","code":"Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.","quantity":"5,400 gowns","number":"Z-3259-2026","classification":"Class II"}],"reason":"Gowns do not consistently meet the minimum liquid-barrier performance required.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of Connecticut.","nationwide":true,"states":[],"units":"5,400 gowns","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99760","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"39806bbd63ccca1f","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99760","record":[{"status":"Ongoing","city":"Brooklyn","state":"NY","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99760","recalling_firm":"New York Embroidery Studio, Inc.","address_1":"140 58th St Ste A Ste 8n","address_2":"","postal_code":"11220-2539","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of Connecticut.","recall_number":"Z-3259-2026","product_description":"New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2.     Packaged in inner packs of 10 and 100 gowns per shipping case.","product_quantity":"5,400 gowns","reason_for_recall":"Gowns do not consistently meet the minimum liquid-barrier performance required.","recall_initiation_date":"20260731","center_classification_date":"20260923","report_date":"20260930","code_info":"Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.","more_code_info":""}]}}