{"recall":{"id":"fda-device-99189","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Windstone Medical Packaging, Inc. recalls 2 products","firm":"Windstone Medical Packaging, Inc.","date":"2026-05-21","reported":"2026-07-08","status":"Ongoing","classification":"Class I","products":[{"name":"A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit","code":"UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.","quantity":"200 units","number":"Z-2620-2026","classification":"Class I"},{"name":"A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit","code":"UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.","quantity":"45 units","number":"Z-2622-2026","classification":"Class I"}],"reason":"Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US Nationwide distribution in the states of PA, GA, CA, WA.","nationwide":true,"states":[],"units":"200 units; 45 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=99189","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0cc3c6098715661a","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[{"at":"2026-11-02T22:17:07.772Z","changes":["Product details, codes or quantities changed","Units: 1080 kits; 200 units; 200 units; 45 units → 200 units; 45 units"]}]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99189","record":[{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99189","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"US Nationwide distribution in the states of PA, GA, CA, WA.","recall_number":"Z-2620-2026","product_description":"A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit","product_quantity":"200 units","reason_for_recall":"Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.","recall_initiation_date":"20260521","center_classification_date":"20260701","report_date":"20260708","code_info":"UDI/DI none, Lot Codes:  237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313."},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99189","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"US Nationwide distribution in the states of PA, GA, CA, WA.","recall_number":"Z-2622-2026","product_description":"A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit","product_quantity":"45 units","reason_for_recall":"Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.","recall_initiation_date":"20260521","center_classification_date":"20260701","report_date":"20260708","code_info":"UDI/DI none, Lot Codes:  237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313."}]}}