{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192645", "product_res_number": "Z-1120-2022", "event_date_initiated": "2022-02-24", "event_date_created": "2022-05-20", "recall_status": "Completed", "res_event_number": "89827", "product_code": "HNN", "product_description": "Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, \n\nIndividual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, \n\nHandle Labeling; 2.5mm slit double bevel", "code_info": "Item # PG 44620MU; Lot # : B923LUC", "firm_fei_number": "3000892087", "recalling_firm": "International Science & Technology, LP, DBA Diamatrix Ltd.", "address_1": "210 Nursery Rd", "city": "Spring", "state": "TX", "postal_code": "77380-1943", "additional_info_contact": "Dominique Armstrong\n800-537-8081 Ext. 4", "reason_for_recall": "Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of \"2.5mm\" when the actual size is \"2.2mm\".", "root_cause_description": "Labeling Change Control", "action": "Between the dates of February 16, 2022 - March 10, 2022, Diamatrix Ltd. issued a \"Urgent: Medical Device Recall Notification. In addition to notifying consignees about the recalled product, the firm asked consignees to take the following actions: \n\n\"\tDiscontinue or do not use Diamatrix Item # PG 44620MU ProTekt 2.2mm Double Bevel Slit knives from Lot B923LUC.\n\n\"\tReturn the product to Diamatrix immediately. Please contact our customer service, 800-867-8081, to obtain a shipping label from Diamatrix.\n\n\"\tAcknowledge this Voluntary Recall by returning the included Medical Device Recall Return Response letter within 3 business days of receiving this Recall letter.\n\n\"\tA complimentary phone call to the phone numbers mentioned below would assist us with immediate tracking and reports to the FDA.", "product_quantity": "90 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.", "openfda": { "k_number": [ "K853598", "K844553", "K861748", "K791980", "K831975", "K874056", "K863665", "K852706", "K855050", "K860331", "K853129", "K834546", "K760191", "K922378", "K853403", "K881669", "K812918", "K852633", "K873385", "K861744", "K853063", "K864290", "K830366", "K842647", "K832844", "K861732", "K853499", "K882402", "K831266", "K874057", "K110166", "K863725", "K843447", "K851790", "K820618", "K874979", "K860332", 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