{ "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": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Tonawanda", "state": "NY", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "65175", "recalling_firm": "Embla System Llc", "address_1": "250 Cooper Ave", "address_2": "N/A", "postal_code": "14150-6633", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: CO, AK, WA, CA, WI, MI, MA OH, DE, FL CA, CT, TX, IL, GA, PA, AZ, DC, VA, MD, UT, IN, MO, NY, NC, OR, NV, NJ, NH, DE, and country of: Canada.", "recall_number": "Z-1532-2013", "product_description": "embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625 RMIV019235 166758580 1010007510 UI007649 RMIV020079 RMIV013196 1010002697 RMIV019658 UI016466 RMIV019659 1010002034 UI016112 UI018160 1010007423 RMRE007779 UI018158 RMIV020145 1010001332 1010002431 1010002432 1010001378 1010006090 1010007484 1010004750 1010003658 1010007351 1010002688 1010002699 UI008431 RMIV009745 RMIV019679 1010007005 1010002088 UI009365 1010003611 1010006891 UI018570 UI022540 1010002262 RMIV019517 RMIV019572 RMRE007959 UI006113 RMIV006948 UI013856 RMIV016367 RMIV019395 RMIV020112 1010005434 1010006883 RMRE007326 RMIV019237 1010006887 1010001991 1010003732 1010003984 UI002603 1010004266 1010006478 1010006800 RMIV019397 1010001928 1010001729 RMIV019166 RMIV019746 RMRE008072 UI016332 UI007631 1010002320 RMIV018044 RMRE007777 1010003067 1010005000 1010005287 RMIV019076 RMIV020194 1010000243 1010003543 1010006931 RMIV017565 RMIV019454 RMRE008087 156096 159046 RMIV020029 1010001256 1010003438 RMIV019940 RMRE008074 1010003546 UI012639 118018636 1010003507 RMIV003685 UI005216 1010003381 1010002913 1010002920 1010002845 168574112 1010006576 1010002702 1010005197 1010006074 UI012593 1010001937 1010003637 UI012586 1010002664 1010004535 1010003817 1010005998 1010006826 1010007710 1010003802 1010000965 1010001001 1010001006 1010001013 1010002659 1010002671 1010002698 1010002670 1010002646 1010002791 1010002835 1010002830 1010002793 1010003559 1010003562 1010003215 1010004145 1010004220 1010005580 1010005576 1010005464 1010005497 1010005469 1010005314 UI019628 UI007951 UI011892 RMRE004711 RMIV013784 UI015720 RMIV019570 RMRE008077 RMRE008073 1010001188 1010006437 1010004274 UI006849 UI009712 RMIV019889 UI003213 UI005546 UI011507 UI015675 RMIV019238 RMIV019254 RMIV019511 1010001255 1010003565 1010002955 UI018536 RMIV019954 RMIV019177 1010001217 UI008038 1010004985 1010002682 167617437 RMIV020243 1010005643 UI003679 1010000951 UI013298 RMIV020078 RMIV020247 1010005730 1010003680 RMIV020054 1010000199 1010007284 UI012571 UI012575 1010002675 UI014387 RMRE007776 IN000380 UI014119 UI016006 UI016355 UI017046 RMIV019982 UI005858 RMIV019919 101003924 1010002837 UI_000670 UI_001339 UI004904 RMIV007125 UI014813 UI017060 UI019513 RMIV019041 144913 RMIV019639 RMIV019778 1010002678 1010004325 1010004310 159699 1010003947 UI011502 UI020772", "product_quantity": "519 units were calibrated at the service center", "reason_for_recall": "Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.", "recall_initiation_date": "20130424", "center_classification_date": "20130611", "termination_date": "20170307", "report_date": "20130619", "code_info": "Serial Numbers: EBG-C1000497 C0914092-EBG EBG-C1002589 EBG-C1002598 EBG-C1001659 EBG-C1001832 EBG-C1001835 EBG-C1001843 EBG-C1001845 EBG-C1002253 EBG-C1002473 EBG-C1002504 EBG-C1002519 EBG-C1002537 EBG-C1002539 EBG-C1001367 EBG-C1001378 EBG-C1001763 EBG-C1000265 EBG-C1002607 EBG-C1002542 EBG-C1003212 EBG-C1001834 EBG-C1001858 EBG-C1001889 EBG-C1002445 EBG-C1003052 EBG-C1002502 EBG-C1002508 EBG-C1001776 C0901065-EBG EBG-C1003078 EBG-C1003084 EBG-C1003085 EBG-C1003161 EBG-C1003165 EBG-C1001230 EBG-C1001275 EBG-C1002688 EBG-C1002500 EBG-C1003055 EBG-C1001970 EBG-C1001972 EBG-C1001973 EBG-C1001983 EBG-C1001986 EBG-C1001518 EBG-C1000112 EBG-C1001308 EBG-C1002771 EBG-C1002863 EBG-c1001330 EBG-C1001237 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EBG-C1002686 EBG-C1000971 EBG-C1000650 EBG-C1001080 EBG-C1001782 EBG-C1002605 EBG-C1001537 EBG-C1001761 EBG-C1001785 EBG-C1002033 EBG-C1002039 EBG-C1002040 EBG-C1002177 EBG-C1002627 EBG-C1001306 EBG-C1002004 EBG-C1002652 EBG-C1002035 C0917072-EBG EBG-C1000110 EBG-C1002164 EBG-C1002591 C0917044-EBG EBG-C1000059 EBG-C1000114 EBG-C1000963 EBG-C1001764 EBG-C1001797 EBG-C1002566 EBG-C1003236 EBG-C1001679 EBG-C1001758 EBG-C1001768 EBG-C1002023 EBG-C1002609 EBG-C1001422 EBG-C1001418 EBG-C1001424 EBG-C1001545 EBG-C1001770 EBG-C1002009 EBG-C1002016 EBG-C1002615 EBG-C1002025 EBG-C1001362 EBG-C1001695 EBG-C1001765 EBG-C1001779 EBG-C1002022 EBG-C1002739 EBG-C1002011 EBG-C1000079 EBG-C1000041 EBG-C1000043 EBG-C1000063 EBG-C1000355 EBG-C1001675 EBG-C1001749 EBG-C1002855 EBG-C1001403 EBG-C1001968 EBG-C1001987 EBG-C1001988 EBG-C1002613 EBG-C1001290 EBG-C1001343 EBG-C1001549 EBG-C1001783 EBG-C1002026 EBG-C1002710 EBG-C1003238 EBG-C1003223 EBG-C1001322 EBG-C1001375 EBG-C1001393 EBG-C1001407 EBG-C1001413 EBG-C1001421 EBG-C1001507 EBG-C1001511 EBG-C1001513 EBG-C1001517 EBG-C1001525 EBG-C1001526 EBG-C1001530 EBG-C1001693 EBG-C1001750 EBG-C1001772 EBG-C1001774 EBG-C1001777 EBG-C1001778 EBG-C1001781 EBG-C1001784 EBG-C1002024 EBG-C1002032 EBG-C1001278 EBG-C1001323 EBG-C1002019 EBG-C1002569 EBG-C1002610 EBG-C1002616 EBG-C1002678 EBG-C1002708 EBG-C1001015 C0914041-EBG EBG-C1001245 EBG-C1002735 EBG-C1001539 EBG-C1002881 EBG-C1002899 EBG-C1000016 EBG-C1001470 EBG-C1001498 EBG-C1001524 EBG-C1001529 EBG-C1001611 EBG-C1001798 EBG-C1001864 EBG-C1001867 EBG-C1001878 EBG-C1001883 EBG-C1000115 EBG-C1000989 EBG-C1001379 EBG-C1001979 EBG-C1002618 EBG-C1002716 EBG-C1001753 EBG-C1001548 EBG-C1001648 EB2-C1000137 EBG-C1003075 C0837037-EBG EBG-C1003065 EBG-C1000578 C0914065-EBG EBG-C1001264 EBG-C1001406 EBG-C1002913 EBG-C1001799 EBG-C1002680 EBG-C1000587 EBG-C1001224 EBG-C1002338 EBG-C1000992 EBG-C1002109 EBG-C1001806 EBG-C1002106 EBG-C1002225 EBG-C1002226 EBG-C1002227 EBG-C1002232 EBG-C1002233 EBG-C1002243 EBG-C1001821 EBG-C1000181 EBG-C1002234 EBG-C1000142 EBG-C1000279 EBG-C1002275 EBG-C1002586 EBG-C1002590 EBG-C1002750 EBG-C1001516 EBG-C1002006 EBG-C1002916 EBG-C1002027 EBG-C1002029 EBG-C1002031 EBG-C1001615 EBG-C1002188 EBG-C1002369 EBG-C1002413 EBG-C1002435 EBG-C1002436 EBG-C1002489 EBG-C1002534 EBG-C1002540 EBG-C1001366 EBG-C1000277 EBG-C1002364 EBG-C1002548 EBG-C1002571 EBG-C1002563 EBG-C1002787 EBG-C1002554 EBG-C1002555 EBG-C1002556 EBG-C1002753 EBG-C1002952 EBG-C1002964 EBG-C1002965 EBG-C1002970 EBG-C1002982 EBG-C1003018 EBG-C1003021 EBG-C1003027 EBG-C1003040 EBG-C1001383 EBG-C1001023 EBG-C1001091 EBG-C1001762 EBG-C1003486 EBG-C1003470 EBG-C1000457 EBG-C1000476 EBG-C1000424 EBG-C1000437 EBG-C1000561 EBG-C1001504 EBG-C1002497 EBG-C1003026 EBG-C1003661 EBG-C1001860 C0914014-EBG EBG-C1001790 EBG-C1000449 EBG-C1002217 EBG-C1002797 EBG-C1002399 EBG-C1002363 EBG-C1002410 EBG-C1002411 EBG-C1002419 EBG-C1002420 EBG-C1002950 C0914045-EBG EBG-C1000052 EBG-C1002267 EBG-C1002021 EBG-C1003582 EBG-C1003620 C0914086-EBG EBG-C1001368 Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625 RMIV019235 166758580 1010007510 UI007649 RMIV020079 RMIV013196 1010002697 RMIV019658 UI016466 RMIV019659 1010002034 UI016112 UI018160 1010007423 RMRE007779 UI018158 RMIV020145 1010001332 1010002431 1010002432 1010001378 1010006090 1010007484 1010004750 1010003658 1010007351 1010002688 1010002699 UI008431 RMIV009745 RMIV019679 1010007005 1010002088 UI009365 1010003611 1010006891 UI018570 UI022540 1010002262 RMIV019517 RMIV019572 RMRE007959 UI006113 RMIV006948 UI013856 RMIV016367 RMIV019395 RMIV020112 1010005434 1010006883 RMRE007326 RMIV019237 1010006887 1010001991 1010003732 1010003984 UI002603 1010004266 1010006478 1010006800 RMIV019397 1010001928 1010001729 RMIV019166 RMIV019746 RMRE008072 UI016332 UI007631 1010002320 RMIV018044 RMRE007777 1010003067 1010005000 1010005287 RMIV019076 RMIV020194 1010000243 1010003543 1010006931 RMIV017565 RMIV019454 RMRE008087 156096 159046 RMIV020029 1010001256 1010003438 RMIV019940 RMRE008074 1010003546 UI012639 118018636 1010003507 RMIV003685 UI005216 1010003381 1010002913 1010002920 1010002845 168574112 1010006576 1010002702 1010005197 1010006074 UI012593 1010001937 1010003637 UI012586 1010002664 1010004535 1010003817 1010005998 1010006826 1010007710 1010003802 1010000965 1010001001 1010001006 1010001013 1010002659 1010002671 1010002698 1010002670 1010002646 1010002791 1010002835 1010002830 1010002793 1010003559 1010003562 1010003215 1010004145 1010004220 1010005580 1010005576 1010005464 1010005497 1010005469 1010005314 UI019628 UI007951 UI011892 RMRE004711 RMIV013784 UI015720 RMIV019570 RMRE008077 RMRE008073 1010001188 1010006437 1010004274 UI006849 UI009712 RMIV019889 UI003213 UI005546 UI011507 UI015675 RMIV019238 RMIV019254 RMIV019511 1010001255 1010003565 1010002955 UI018536 RMIV019954 RMIV019177 1010001217 UI008038 1010004985 1010002682 167617437 RMIV020243 1010005643 UI003679 1010000951 UI013298 RMIV020078 RMIV020247 1010005730 1010003680 RMIV020054 1010000199 1010007284 UI012571 UI012575 1010002675 UI014387 RMRE007776 IN000380 UI014119 UI016006 UI016355 UI017046 RMIV019982 UI005858 RMIV019919 101003924 1010002837 UI_000670 UI_001339 UI004904 RMIV007125 UI014813 UI017060 UI019513 RMIV019041 144913 RMIV019639 RMIV019778 1010002678 1010004325 1010004310 159699 1010003947 UI011502 UI020772" } ] }