{ "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": "Mansfield", "state": "MA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "82426", "recalling_firm": "COVIDIEN LLC", "address_1": "15 Hampshire St", "address_2": "N/A", "postal_code": "02048-1113", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.", "recall_number": "Z-1213-2019", "product_description": "Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO\t (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO\t (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII\t (6)BOX PST01134 LAP CHOLE KIT ST JOHN S\t (7)KIT00599 LAPARO GENERICO X1\t (8)KIT00608 APENDICECTOMIA LAP X1\t (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA\t (10)KIT2951V CHOLECYSTECT BORNHOLM\t (11KIT2963 APPENDECTOMY KIT X1\t(12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1\t The Covidien Endo Grasp\" Auto Suture\" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures. 1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO\t Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO\t0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII\t0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S\t0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1\t0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1\t0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA\t0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM\t0217123010 (11KIT2963 APPENDECTOMY KIT X1\t0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1\t0217127223 (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO\t Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO\t0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII\t0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S\t0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1\t0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1\t0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA\t0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM\t0217123010 (11KIT2963 APPENDECTOMY KIT X1\t0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1\t0217127223 (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO\t Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO\t0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII\t0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S\t0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1\t0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1\t0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA\t0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM\t0217123010 (11KIT2963 APPENDECTOMY KIT X1\t0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1\t0217127223", "product_quantity": "148 units", "reason_for_recall": "Sterilization method used was not consistent with the labeling and the approved sterilization method", "recall_initiation_date": "20190313", "center_classification_date": "20190423", "termination_date": "20200423", "report_date": "20190501", "code_info": "(1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- Lot Numbers: 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA Lot Numbers: 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO Lot Number: 0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII Lot No: 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S Lot numbers: :0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 Lot Numbers: 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 Lot No. 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA Lot No.0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM Lot No. 0217123010 (11KIT2963 APPENDECTOMY KIT X1 Lot No. 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 Lot No. 0217127223 1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223 (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223 (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223" } ] }