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 2 minutes ago
Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the…Medline Industries, LP recalls Medline Neuro Sponges and 30 more products
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product…Becton Dickinson & Co. recalls BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use and 1 more products
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon…American Regent, Inc. recalls Levocarnitine Injection
Labeling: Missing LabelWater-Jel Technologies, LLC recalls Lidocaine Wound Gel
Failed PH SpecificationsScope Health recalls Optase Dry Eye Intense Drops
Lack of Assurance of SterilityHikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.Alcon Research LLC recalls Systane and 1 more products
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.Wells Pharma of Houston LLC recalls Phenylephrine Hydrochloride Injectable Solution and 6 more products
cGMP deviations.Thea Pharma, Inc. recalls iVIZIA and 1 more products
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute…
Products were incorrectly labeled with a 5-year shelf life.Remel Europe Ltd. recalls Oxoid Agglutinating Sera
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds.Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variantsUvlizer c/o RAIS INTERNATIONAL LLC recalls The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure…
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety…Uvlizer c/o RAIS INTERNATIONAL LLC recalls The product is a handheld ultraviolet-C germicidal wand and contains a combination of…
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety…Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator and 3 more products
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.Davol, Inc. recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat
Potential for product to contain foreign matter, confirmed to be inspect fragments.Integra LifeSciences Corp. (NeuroSciences) recalls CUSA Clarity C7000 Console
Software issue that renders the touch screen unresponsive.Foundation Medicine, Inc. recalls Protocol Configuration Tool
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.Beckman Coulter, Inc. recalls Access Total T4 Calibrator
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product…Micro-X Ltd. recalls Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
X-Ray generator may malfunction resulting in the X-Ray being inoperable.Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit and 2 more products
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump…SurgiSmoke Solutions recalls Flamingo Funnel Small and 2 more products
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.A little guidance
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