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
Direct Rx recalls DULOXETINE D/R
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitElevate Oral Care recalls Povi-One
sub potencyAjanta Pharma USA Inc recalls Fenofibrate Capsules
CGMP DeviationsCareFusion 213, LLC recalls BD ChloraPrep Clear and 3 more products
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.Amgen, Inc. recalls Corlanor and 4 more products
Presence of Foreign Substance.Annora Pharma Private Limited recalls Lacosamide Tablets
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.Beta Bionics, Inc. recalls iLet Bionic Pancreas
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the…Accriva Diagnostics, Inc. recalls directCHECK ACT-LR whole blood quality control
Assayed Whole blood control contains labeling with incorrect performance range.Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before…AMD Medicom Inc. recalls Ritmed Neurological Sponges and 1 more products
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not…Philips Medical Systems Nederland B.V. recalls Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for… and 1 more products
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation…Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.Abiomed, Inc. recalls Automated Impella Controller
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.BD Switzerland Sarl recalls BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta"…
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely.GE Medical Systems, LLC recalls Giraffe OmniBed and 2 more products
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.Staar Surgical AG recalls Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product…
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.Mito Red Light Inc recalls Mito Red Light
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System and 1 more products
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System and 2 more products
Blender knob shaft can loosen, which can affect the delivered oxygen concentration.Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645…
Due to unsealed portions of pouches.ConMed Corporation recalls ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip and 10 more products
Potential for overpressure alerts.Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System and 2 more products
Due to 11 volt Backup Battery failures.Medline Industries, LP recalls Medline EBSI Kit EBSI1534 and 33 more products
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive.A little guidance
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