Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceTriMed Inc.Class IIVolar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
- 2024-02-07FDA-DeviceAtriCure, Inc.Class IIPackaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
- 2024-02-07FDA-DeviceAtriCure, Inc.Class IICryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IITIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIPS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIPS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIPS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIDUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIDUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIDUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIDUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIDURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIDURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIDURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IILARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIPRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIRGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIRGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIRGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IILEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IILEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IILEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IILEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IILEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIP7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIP7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIHOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
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