{"recall":{"id":"fda-device-99151","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3","firm":"ConvaTec, Inc","date":"2026-06-08","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R","code":"Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631","quantity":"4230 units","number":"Z-2677-2026","classification":"Class II"}],"reason":"Surgical dressing manufactured out of specification (greater thickness).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO.","nationwide":true,"states":[],"units":"4230 units","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=99151","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"31f60477fd7794da","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=99151","record":[{"status":"Ongoing","city":"Greensboro","state":"NC","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99151","recalling_firm":"ConvaTec, Inc","address_1":"7815 National Service Rd Ste 600","address_2":"N/A","postal_code":"27409-9403","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO.","recall_number":"Z-2677-2026","product_description":"Aquacel Ag Surgical SP   REF: 413556  9cm x 15cm/3.5 in. x 6 in., Sterile R","product_quantity":"4230 units","reason_for_recall":"Surgical dressing  manufactured out of specification (greater thickness).","recall_initiation_date":"20260608","center_classification_date":"20260707","report_date":"20260715","code_info":"Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631"}]}}