{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Newport News", "state": "VA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "83144", "recalling_firm": "Burlington Medical, LLC", "address_1": "PO Box 3194", "address_2": "3 Elmhurst St", "postal_code": "23603-1137", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.", "recall_number": "Z-2122-2019", "product_description": "Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.", "product_quantity": "807", "reason_for_recall": "The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.", "recall_initiation_date": "20190607", "center_classification_date": "20190730", "termination_date": "20230428", "report_date": "20190807", "code_info": "Serial Numbers: 443646 419128 418103 418484 388010 376800 376806 419076 441180 441183 441186 441113 441181 441139 441136 441130 441131 441135 443748 423654 414987 420870 420877 443626 419123 388250 388245 383021 383032 381507 388123 381663 381508 376803 440957 440956 440966 433273 433267 440958 433270 414813 414814 414836 414837 414838 384534 388075 378637 414934 418310 418308 418302 418307 418303 383136 420902 424097 418102 418336 378749 409409 409435 381660 419139 383147 383145 419275 419274 418368 433348 408393 408010 408390 408316 409467 383081 388121 419246 424109 414884 408307 408322 408317 408313 408344 408330 408377 388248 378630 378638 378581 440846 433424 440842 441224 408308 408305 409448 408320 408310 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