{ "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": "Ongoing", "city": "Le Noirmont", "state": "N/A", "country": "Switzerland", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "86419", "recalling_firm": "Bien-Air Surgery Sa", "address_1": "rue de l' ouest 2b", "address_2": "N/A", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide distribution including in the states of CA, MI and MN.", "recall_number": "Z-0180-2021", "product_description": "Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.", "product_quantity": "N/A", "reason_for_recall": "The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.", "recall_initiation_date": "20200911", "center_classification_date": "20201021", "report_date": "20201028", "code_info": "Model 1600998 / Catalog number 1600998-001 Serial Numbers: 17K0059 19A0042 16H0001 16H0002 16H0003 16H0004 16H0005 16H0006 16H0007 16H0008 16H0009 16H0010 16H0011 16H0012 16H0013 16H0014 16H0015 16H0016 16H0017 16H0018 16H0019 16H0020 16H0021 16H0022 16H0023 16H0024 16H0025 16J0001 16J0002 16J0003 16J0004 16J0005 16J0006 16J0007 16J0008 16J0009 16J0010 16J0011 16J0012 16J0013 16J0014 16J0015 16J0016 16J0017 16J0018 16J0019 16J0020 16J0021 16J0022 16J0023 16J0024 16J0025 16J0026 16J0027 16J0028 16J0029 16J0030 16L0001 16L0002 16L0003 16L0004 16L0005 16L0006 16L0007 16L0008 16L0009 16L0010 16L0011 16L0012 16L0013 16L0014 16L0015 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