{ "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": "115501", "product_res_number": "Z-0804-2013", "event_date_initiated": "2013-01-14", "event_date_posted": "2013-02-12", "recall_status": "Terminated", "event_date_terminated": "2013-07-01", "res_event_number": "64177", "product_code": "ILO", "k_numbers": [ "K920581" ], "product_description": "BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.", "code_info": "Affected product will be identified by date of manufacture from January 2010 through October 2012", "firm_fei_number": "1000125378", "recalling_firm": "Breg Inc", "address_1": "2885 Loker Ave E", "city": "Carlsbad", "state": "CA", "postal_code": "92010-6626", "additional_info_contact": "Carol Emerson\n800-321-0607", "reason_for_recall": "The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.", "root_cause_description": "Packaging", "action": "The firm, BREG, sent an \"URGENT: MEDICAL DEVICE RECALL\" letter dated January 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product; complete the Return Response Form by email, Fax or mail; and contact Breg for a Return Authorization for the affected product and request replacement by contacting Breg Customer Care at 800-321-0607. Note: response is required even if you have no affected inventory.\n\nShould you have any questions regarding this communication or need to report an adverse event, please contact Breg Customer Care at 800-321-0607.", "product_quantity": "44,883 units", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.", "openfda": { "k_number": [ "K925677", "K801301", "K884255", "K891091", "K900356", "K923643", "K964354", "K961855", "K760804", "K832820", "K891603", "K955326", "K955057", "K962537", "K963261", "K926151", "K945067", "K915196", "K944971", "K945853", "K904998", "K760910", "K930918", "K970533", "K940160", "K890852", "K940429", "K761254", "K832819", "K072152", "K902269", "K953532", "K760782", "K891152", "K893706", "K040317", "K921540", "K945399", "K830757", "K890853", "K902268", "K930634", "K931203", "K943497", "K891092", "K912722", "K964710", "K910061", "K940858", "K070402", "K852495", "K883681", "K961425", "K962983", 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Circulating", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.5720", "device_class": "2" } } ] }