{ "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": 12 } }, "results": [ { "cfres_id": "219359", "product_res_number": "Z-2069-2026", "event_date_initiated": "2026-03-25", "event_date_posted": "2026-05-06", "recall_status": "Open, Classified", "res_event_number": "98660", "product_code": "HNR", "product_description": "DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23", "code_info": "Lot Code: Model No: DVF4005-23\nUDI-DI: (01)10817489021658(11)250924(17)280924(10)M50529\nLot Number: M50529\nExpiration Date: 09/04/2028", "firm_fei_number": "3007589150", "recalling_firm": "Katalyst Surgical, LLC", "address_1": "722 Goddard Ave", "city": "Chesterfield", "state": "MO", "postal_code": "63005-1100", "additional_info_contact": "Alex Bergoudian\n+1-636-5365950", "reason_for_recall": "Field Safety Corrective Action for IFU in DEX Forceps and Scissors.", "root_cause_description": "Under Investigation by firm", "action": "A Field Safety Notification: Field Safety Corrective Action for IFU in DEX Forceps and Scissors dated 3/19/26 was sent to customers.\n\nFIELD SAFETY ACTIONS REQUIRED\nAs a customer identified in the receipt of one or more of the affected lots, you are requested/required to take the following steps:\n1. Please confirm receipt of this Field Safety Notification by email, either by replying to the sender or using the email addresses listed in the signature at the bottom of this notice.\n2. Review the Individualized List of Affected Lot Numbers by Customer provided in the email for lots that were distributed to your facility. Identify all of these lots that currently remain in your stock and place them on hold.\n3. Provide information to Katalyst Surgical team identifying which lots are currently in stock and on hold at your facility. Katalyst Surgical will send a replacement correct IFU for each affected box.\n4. Upon receipt of the correct IFU, remove the incorrect IFU, replace the correct IFU in the box, and destroy the incorrect IFU. Approval for Modification including instructions will accompany the replacement IFUs.\n5. We recommend you reach out to your customers/users of these DEX products with this information. Katalyst Surgical will gladly provide correct replacement IFU documents to you for further distribution.\nKatalyst Surgical deeply regrets the inconvenience this causes. We assure you of our continuous support and commitment to safety and quality. Please do not hesitate to contact our team if you have any further questions.", "product_quantity": "5 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.", "openfda": { "k_number": [ "K834355", "K791986", "K022835", "K811658", "K851792", "K761251", "K803194", "K770097", "K851791", "K891487", "K852057", "K864266", "K854869", "K770100", "K844129", "K770104", "K863991", "K771003", "K885230", "K881049", "K800368", "K801467", "K842697", "K770102", "K863727", "K770101", "K883197", "K860915", "K880274", "K861141", "K864071", "K843992", "K863992", "K770099", "K770105", "K864183", "K861057", "K893199", "K895434", "K850119", "K864003", "K761252", "K823174", "K801465" ], "device_name": "Forceps, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4350", "device_class": "1", "registration_number": [ "3005440795", "3009465247", "9611502", "3004467263", "3002808022", "3039414397", 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