Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-05-22FDA-DeviceEthicon Endo-Surgery IncClass IEndoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- 2019-05-22FDA-DeviceEthicon Endo-Surgery IncClass IEndoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- 2019-05-22FDA-DeviceEthicon Endo-Surgery IncClass IEndoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- 2019-05-22FDA-DeviceEthicon Endo-Surgery IncClass ICurved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- 2019-05-22FDA-DeviceEthicon Endo-Surgery IncClass ICurved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- 2019-05-22FDA-DeviceEthicon Endo-Surgery IncClass ICurved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- 2019-05-22FDA-DeviceEthicon Endo-Surgery IncClass ICurved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- 2019-05-15FDA-DeviceConmed CorporationClass IIConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
- 2019-05-15FDA-DeviceConmed CorporationClass IIConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
- 2019-05-15FDA-DeviceConmed CorporationClass IIConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
- 2019-05-15FDA-DeviceConmed CorporationClass IIConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
- 2019-05-15FDA-DeviceConmed CorporationClass IIConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
- 2019-05-15FDA-DeviceConmed CorporationClass IIConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
- 2019-05-15FDA-DeviceZimmer Biomet, Inc.Class IIT7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
There is a potential of fracture, bending or shearing of the driver.
- 2019-05-15FDA-DeviceZimmer Biomet, Inc.Class IIT7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
There is a potential of fracture, bending or shearing of the driver.
- 2019-05-15FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica Sample Handler Prime, Material Number 11069001
There were multiple issues identified in the system software which required an update.
- 2019-05-15FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1600 Analyzer, Material Number 11066000
There were multiple issues identified in the system software which required an update.
- 2019-05-15FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1300 Analyzer, Material Number 11066001
There were multiple issues identified in the system software which required an update.
- 2019-05-15FDA-DeviceSiemens Medical Solutions USA, IncClass IICios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patient
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
- 2019-05-15FDA-DeviceElekta LimitedClass IIElekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
- 2019-05-15FDA-DeviceAbbott Laboratories, IncClass IIAbbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
- 2019-05-15FDA-DeviceSiemens Medical Solutions USA, IncClass IICios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may
Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
- 2019-05-15FDA-DeviceMedica CorporationClass IIMedica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
- 2019-05-15FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- 2019-05-15FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- 2019-05-15FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- 2019-05-15FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- 2019-05-15FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- 2019-05-15FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- 2019-05-15FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
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