{ "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": 4 } }, "results": [ { "cfres_id": "221001", "product_res_number": "Z-2619-2026", "event_date_initiated": "2026-05-21", "event_date_posted": "2026-07-01", "recall_status": "Open, Classified", "res_event_number": "99189", "product_code": "LRO", "product_description": "A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit", "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.", "firm_fei_number": "1000125955", "recalling_firm": "Windstone Medical Packaging, Inc.", "address_1": "1602 4th Ave N", "city": "Billings", "state": "MT", "postal_code": "59101-1521", "additional_info_contact": "Field Corrective Action\n406-259-6387", "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.", "root_cause_description": "Material/Component Contamination", "action": "AMS ALIGNED MEDICAL SOLUTIONS issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/21/2026 via email. The notice explained the issue, potential risk, and requested the following: \n\"AMS requests that you undertake the following activities:\n1. Immediately check your inventory for the recalled products listed above and place them under quarantine. \n2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack. This sticker will read: \nRECALL NOTICE\nCARDINAL HEALTH announced the recall of 5110 Webcol\" Large Alcohol Prep Pad contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall.\n\" At the time the kit is opened for use any Cardinal Alcohol Prep Pad should be identified and set aside.\n\" The recalled Cardinal Alcohol Prep Pad should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.\n3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. \n4. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. \n5. Please complete the Recall Reply Form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand.\" \nFor questions or concerns: fieldcorrectiveaction@alignedmedicalsolutions.com.", "product_quantity": "1080 kits", "distribution_pattern": "US Nationwide distribution in the states of PA, GA, CA, WA.", "openfda": { "k_number": [ "K970187", "K871434", "K890570", "K902887", "K935741", "K935740", "K023276", "K931758", "K980137", "K950574", "K945831", "K872448", "K890726", "K872011", "K914037", "K914036", "K920267", "K932221", "K924468", "K895202", "K931760", "K951149", "K961863", "K920292", "K854292", "K934428", "K874439", "K910365", "K963443", "K913136", "K890729", "K934028", "K854095", "K881083", "K871459", "K871322", "K905004", "K894685", "K935483", "K971061", "K935686", "K041080", "K964921", "K885090", "K213481", "K892389", "K925467", "K944044", "K970286", "K212258", "K963715", "K905459", "K951478", "K931824", 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Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }