{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218208", "product_res_number": "Z-1485-2026", "event_date_initiated": "2026-01-15", "event_date_posted": "2026-03-02", "recall_status": "Open, Classified", "res_event_number": "98301", "product_code": "GWG", "k_numbers": [ "K983365" ], "product_description": "Brand Name: AESCULAP\nProduct Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM\nModel/Catalog Number: FF399R\nSoftware Version: N/A\nProduct Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM\nComponent: N/A", "code_info": "Mode No. FF399R; \nUDI-DI 04038653065547; \nSerial Numbers:\n4595, 4619, 4657, 4764, 4592, 4596, 4598, 4601, 4606, 4607, 4608, 4612, 4616, 4618, 4620, 4621, 4623, 4659, 4661, 4662, 4667, 4670, 4673, 4674, 4688, 4689, 4746, 4748, 4757, 4758, 4760, 4761, 4762, 4767, 4768, 4771, 4773, 4774, 4779, 4780, 4784, 4786, 4789, 4791, 4792, 4795, 4799, 4811, 4812, 4818, 4819, 4821, 4822, 4824, 4825, 4826, 4827, 4836, 4838, 4841, 4842, 4843, 4854, 4856, 4858, 4864, 4868, 4869, 4880, 4882, 4886, 4890, 4891, 4892, 4893, 4899, 4901, 4902, 4907, 4914, 4921, 4927, 4940, 4951, 4959, 4967, 4968, 4970, 4971, 4972, 4973, 4974, 4975, 4976, 4990, 4994, 4995, 5000, 5004, 5015, 5024, 5035, 5036, 5042, 5057, 5058, 5059, 5062, 5063, 5064, 5072, 5076, 5081, 5084, 5106, 5112, 5115, 5117, 5118, 5119, 5121, 5123, 5165, 5166, 5168, 5172;", "firm_fei_number": "2916714", "recalling_firm": "Aesculap Inc", "address_1": "3773 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8217", "additional_info_contact": "Allison Longenhagen\n001-484-2408373", "reason_for_recall": "There is the potential for the length of the trocar shaft to be too long.", "root_cause_description": "Under Investigation by firm", "action": "on January 28, 2026 URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters were sent to customers.\nActions to be taken:\n- Review the attachment Aesculap AG Urgent Field Safety Notice in its entirety. \n- If it is determined that a portion of the visual field is obscured, the manufacturer recommends rotating the device to compensate for the restricted view (refer to the attached Urgent Field Safety Notice from the manufacturer). Note: Devices are not being removed from the market, this is a field notification. \n- Return the completed Urgent Medical Device Correction Acknowledgement Form to Aesculap, Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt. \nAction planned by Aesculap AG to correct the problem:\nTo address this issue, the manufacturer is implementing additional inspections of the optical system and introducing clearly defined acceptance criteria, along with other corrective actions.\nShould there be any questions, comments, or concerns regarding the product you have received, please feel free to contact (844-903-6417) or recalls@bbraunusa.com", "product_quantity": "126 units", "distribution_pattern": "US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, WA.", "openfda": { "k_number": [ "K222735", "K963642", "K210251", "K171332", "K925881", "K052745", "K010341", "K954394", "K993539", "K061135", "K955598", "K961300", "K983365", "K253602", "K954938", "K940273", "K961173", "K022198", "K933244", "K940096", "K181116", "K945296", "K142315", "K002704", "K020507", "K923646", "K243429", "K131434", "K001630", "K170462", "K031858", "K991989", "K013759", "K964281", "K942955", "K003914", "K181731", "K931973", "K934154", "K923479", "K132931", "K942413", "K233391", "K942249", "K170667", "K955351", "K152699", "K961406", "K230125", "K021050", "K950154", "K223615", "K965078", "K002572", "K993568", "K941239", "K072410", "K953685", "K180146", "K180270", "K201308", "K232618", "K960915", "K014149", "K945572", "K960792", "K970162", "K250752", "K953173", "K211202", "K191861", "K991069", "K953554", "K232159", "K924977", "K002788", "K982837", "K253679", "K954899", "K990333", "K002330", "K182211", "K934196", "K161112", "K043128", "K982819", "K201840", "K971340", "K162880", "K190719", "K945633", "K200925", "K081102" ], "registration_number": [ "3025482817", "8010510", "2432235", "3021744379", "3005809810", "1721676", "3013247477", "9615010", "3005168196", "3015449142", "3016099036", "3018094310", "3010707607", "3010202439", "1219913", "8010487", "3003713161", "3014342096", "2648666", "3008253300", "3012322232", "9614945", "1319639", "3006546082", "3025341449", "3020703212", "3001592626", "3009420598", "2936485", "9614434", "2916714", "3024021261", "3013505638", "9681191", "3010177712", "2020550", "3010034260", "3015967359", "2183744", "8010168", "1418479", "3012447612", "3009538961", "3016591327", "3015615738", "9610617", "1221826", "3003418325", "8020888", "9610612", "2183911", "2011171", "3013758550", "2244478", "3028006458", "8010418", "3008837339", "3004542960", "3003915875", "3015531529", "2027009", "1000343527", "3016050940", "9611102", "3007303113", "3004608878", "2029275", "3002807090" ], "fei_number": [ "3025482817", "2432235", "3021744379", "4430", "3005809810", "1721676", "3013247477", "3002808268", "3005168196", "1000138054", "3015449142", "3016099036", "3007019572", "3007475226", "3004207793", "1000136269", "3018094310", "3010707607", "1219913", "3014342096", "3003713161", "2648666", "3008253300", "3012322232", "3006546082", "3025341449", "3020703212", "3001592626", "3003481798", "3000226659", "3009420598", "2936485", "2916714", "3024021261", "3013505638", "3010177712", "2020550", "3010034260", "3015967359", "2183744", "3002808273", "1000306431", "3008207730", "1418479", "3012447612", "3009538961", "3016591327", "3015615738", "1221826", "3003418325", "1000453845", "2011171", "3013758550", "3002806315", "3028006458", "3008837339", "3007130719", "3004542960", "3003915875", "3015531529", "2027009", "1000343527", "3016050940", "3007303113", "3004608878", "1000116142", "3006003617", "3002808001" ], "device_name": "Endoscope, Neurological", "medical_specialty_description": "Neurology", "regulation_number": "882.1480", "device_class": "2" } } ] }