{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "66345", "product_res_number": "Z-0496-2008", "event_date_initiated": "2007-07-18", "event_date_posted": "2008-01-12", "recall_status": "Terminated", "event_date_terminated": "2009-09-25", "res_event_number": "45870", "product_code": "HNN", "product_description": "PremierEdge MICROSURGICAL KNIFE, 3.2mm Clear Cornea Knife, Item Code/REF: PE 3132, OASIS Glendora, CA 91741", "code_info": "Lot No: DK0107R", "firm_fei_number": "2083373", "recalling_firm": "Oasis Medical Inc", "address_1": "514 S Vermont Ave Bldg 510-528", "city": "Glendora", "state": "CA", "postal_code": "91741-6205", "additional_info_contact": "Robyn Scopis\n800-528-9786", "reason_for_recall": "Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL", "root_cause_description": "Device Design", "action": "A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS\nMedical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.", "product_quantity": "28,319 individual knives (Z-0485-0516-2008)", "distribution_pattern": "Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia", "openfda": { "k_number": [ "K851790", "K821440", "K832844", "K861334", "K831266", "K852706", "K881669", "K812450", "K760187", "K110166", "K861744", "K855050", "K853499", "K853403", "K841951", "K861732", "K860852", "K822112", "K791981", "K834546", "K853063", "K863665", "K873385", "K791980", "K760186", "K864290", "K830366", "K850049", "K860305", "K812620", "K781465", "K874056", "K922378", "K861491", "K812918", "K874979", "K842647", "K844553", "K863725", "K840855", "K820618", "K853129", "K882402", "K843447", "K861748", "K860331", "K760191", "K860332", "K874057", "K831975", 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