{ "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": "194629", "product_res_number": "Z-1467-2022", "event_date_initiated": "2022-06-07", "event_date_created": "2022-07-26", "recall_status": "Open, Classified", "res_event_number": "90519", "product_code": "HIH", "k_numbers": [ "K031787", "K132015" ], "product_description": "TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal.\n\nModel Number: 7209808", "code_info": "UDI-Device Identifier (GTIN/UPN)\n10884521749931\nSerial Number:\nYF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182", "firm_fei_number": "1282497", "recalling_firm": "Covidien Llc", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "Medtronic Customer Service\n800-962-9888", "reason_for_recall": "Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.", "root_cause_description": "Device Design", "action": "Medtronic issued Urgent Medical Device Recall letter on 6/7/22 (Field Action #: FA1259) via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take:\n\"Identify and quarantine all affected product. The enclosed Customer Notification DetailReport includes affected product for your facility.\n\" Return all affected product in your inventory to Medtronic.\na. Product purchased directly from Medtronic:\nrs.covidienfeedbackcustomerservice@medtronic.com\nb. Product purchased through distributor: rs.gmbfcamitg@medtronic.com\n\" Your local Medtronic Representative can assist you as necessary in initiating the return of this product.\n\" Complete the enclosed Customer Confirmation Form and email it to\nrs.covidienfeedbackcustomerservice@medtronic.com\n\" If you have questions or concerns regarding this recall, please contact Medtronic CustomerService at 800-854-3570.", "product_quantity": "33 units", "distribution_pattern": "AZ\nCA\nCO\nIL\nKS\nMA\nMI\nMN\nMO\nNY\nOK\nPA\nTN\nTX\nTX\nWA\n\nForeign:\nUnited Kingdom\nIreland\nNetherlands\nReunion\nSpain", "openfda": { "k_number": [ "K120593", "K152723", "K200038", "K031974", "K945265", "K003802", "K950036", "K022480", "K102686", "K211227", "K934286", "K914108", "K954648", "K961688", "K240978", "K081070", "K252793", "K952186", "K896917", "K201970", "K260984", "K123330", "K151275", "K013870", "K193007", "K992027", "K982771", "K891451", "K180496", "K112134", "K950255", "K971188", "K142029", 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