Medicine, medical device and cosmetics recalls in United States
Recalls of medicines, medical devices, supplements, cosmetics and personal care products published in United States, newest first.
1,518 recalls, newest first · Checked 0 minutes ago
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use… and 1 more products
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM and 1 more products
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a…Siemens Medical Solutions USA, Inc recalls SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel… and 3 more products
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue…Focalyx Technologies, LLC. recalls Focalyx Fusion
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with…Vantive US Healthcare LLC recalls PRISMAFLEX ST100 SET US and 7 more products
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.Boston Scientific Corporation recalls AXIOS Stent and Electrocautery-Enhanced Delivery System and 5 more products
Increased reports of stent deployment and expansion issues.Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or…Changchun Wancheng Bio-Electron Co., Ltd. recalls LotFancy Urinary Tract Infection Urine and 10 more products
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S.Etac A/S recalls Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: and 3 more products
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke.Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number… and 6 more products
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when…Olympus Corporation of the Americas recalls Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog… and 29 more products
Devices which did not undergo thermoforming could deform and lose performance.Beckman Coulter, Inc. recalls COULTER DxH Diluent
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.Vortex Surgical Inc. recalls Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens and 12 more products
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.Handelnine Global LLC recalls Rheumacare capsules
CGMP Deviations: product found to contain lead.Sun Pharmaceutical Industries Inc recalls Diclofenac Sodium
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.Granules Pharmaceuticals Inc. recalls Trazodone Hydrochloride
Presence of Foreign Tablets/CapsulesGreen Lumber Holdings, LLC recalls Green Lumber Natural Fuel For Men capsule
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafilUnichem Pharmaceuticals USA Inc. recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.CareFusion 303, Inc. recalls BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System…
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital…Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy
Due to a manufacturing issue and electrical grounding of systems.NIPRO Technical Services, Inc. recalls Conductivity Standard Solution Catalog/Model Numbers: 10001
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for…LimFlow, Inc. recalls Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
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