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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Nasal jejunal feeding tubes (NJFT-10) from Wilson-Cook Medical are recalled for being packaged without the required nasal transfer tube component, preventing safe use.
Vortex Surgical Inc. is recalling Rumex Disposable Diamond Dusted ILM Elevators due to voids in sterilization pouch seals. The compromised barrier could allow contamination and lead to infection during surgical procedures.
Olympus Corporation is recalling Disposable Triple Lumen Sphincterotomes (Model KD-401Q-0725) because some units did not undergo proper thermoforming during manufacturing and could deform and lose performance.
The LH One Step Ovulation Test Device was distributed before obtaining required FDA clearance. These test devices may provide false or inaccurate results, potentially leading to inappropriate medical intervention.
Maquet's Venous Bubble Sensor (Model 701055720) is recalled due to connecting cable durability issues that may cause sensor damage or disconnection errors on connected medical devices.
Siemens has recalled NAEOTOM Alpha.Prime CT system software applications that were distributed without FDA 510(k) clearance. Affected systems are located in the US, Canada, Costa Rica, India, and Israel.
Olympus is recalling 413 units of Single Use 3-Lumen Sphincterotomes (Model KD-VC412Q-0215) distributed in the United States because some devices may not have undergone proper thermoforming and could deform and lose performance.
Changchun Wancheng Bio-Electron's male fertility sperm test was distributed without required FDA clearance. The device may produce false diagnostic results when used at home.
Biomerieux is recalling VITEK 2 Gram-negative Susceptibility Cards due to potential quality control failures and false antibiotic resistance results. The cards are used in clinical laboratories for antibiotic susceptibility testing.
The FDA is recalling Vivoo Vaginal pH Test kits distributed without FDA clearance. The tests may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Changchun Wancheng Bio-Electron's Exploro male fertility test was distributed without required FDA clearance and may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Olympus recalls 1,490 Disposable Triple Lumen Sphincterotomes due to a manufacturing defect where improper thermoforming could cause the devices to deform and lose performance during surgical use.
Olympus is recalling sphincterotomes that did not undergo proper thermoforming, which could cause device deformation and loss of performance. The 5,089 affected units were distributed throughout the US and internationally.
Vivoo Sodium, Vitamin C, and Hydration test strips distributed without FDA clearance may provide inaccurate diagnostic results, potentially leading to inappropriate medical intervention.
ETAC A/S recalls Molift Mover 300 mobile hoists due to bolt deformation in the lifting bar joint that can prevent proper device functionality.
Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma test cartridges due to inaccurate test results that may falsely classify patients as having or requiring additional testing for Alzheimer's disease amyloid pathology.
Menopause test cassette distributed before FDA approval recalled due to risk of false or inaccurate diagnostic results that could lead to inappropriate medical intervention.
Vortex Surgical is recalling Lindsell Sutured IOL Marker scleral markers due to potential voids in sterile pouches. Compromised seals could allow bioburden contamination that may lead to infection.
Vortex Surgical Inc. is recalling 25GA Convenience Kits due to potential voids in Tyvek pouch seals that could compromise sterility and lead to infection risk.
Olympus has recalled its Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during endoscopic procedures.
Olympus Corporation is recalling Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Some devices did not undergo thermoforming and could deform and lose performance.
Olympus is recalling 3,954 Single Use 3-Lumen Sphincterotome V devices due to a manufacturing defect where some units may have failed thermoforming, potentially causing deformation and loss of performance.
Olympus recalls Disposable Triple Lumen Sphincterotomes due to incomplete thermoforming that could cause device deformation and loss of performance. Affected units may not function properly during papillotomy procedures.
ETAC A/S is recalling 95 Molift Mover 205 patient lift devices due to a defective mounting bolt that can break and cause material deformation, limiting joint mobility and device functionality.
ETAC A/S is recalling Molift 2-point sling bars due to bolts breaking during assembly and testing. The defect causes material deformation that prevents proper functionality in this assistive device.
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