💊 Drugs Class I - Dangerous
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Failed dissolution specifications: below specification results at stability 12-month
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
Marlex Pharmaceuticals
💊 Drugs Class I - Dangerous
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
Marlex Pharmaceuticals
💊 Drugs Class I - Dangerous
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
ISee Ortho-K Lens
PARAGON VISION SCIENCES
🏥 Medical Devices Class I - Dangerous
Manufactured lenses are not covered by existing FDA approval
🏥 Medical Devices Class I - Dangerous
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Allura Xper series
Philips Medical Systems Nederland B.V.
🏥 Medical Devices Class I - Dangerous
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
🏥 Medical Devices Class I - Dangerous
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
ZVU Functional GI Software, REF: ZVU-3
Diversatek Healthcare
🏥 Medical Devices Class I - Dangerous
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Azurion
Philips Medical Systems Nederland B.V.
🏥 Medical Devices Class I - Dangerous
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Fargo Ortho-K Lens
PARAGON VISION SCIENCES
🏥 Medical Devices Class I - Dangerous
Manufactured lenses are not covered by existing FDA approval
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
🏥 Medical Devices Class I - Dangerous
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
MultiDiagnost-Eleva
Philips Medical Systems Nederland B.V.
🏥 Medical Devices Class I - Dangerous
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
🏥 Medical Devices Class I - Dangerous
Sterility of device may be compromised due to breach of the chevron seal of the packaging
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Aesculap Implant Systems
🏥 Medical Devices Class I - Dangerous
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
ARGO Xplorer ATVs
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
Incorrectly installed check valves and vent hoses can lead to fuel overflow, posing a fire hazard.
Emporia Smart Plugs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The recalled smart plugs are not adequately grounded and can pose an electric shock to the user.
Liquefied Petroleum Gas Compact Regulators
Engineered Controls International LLC, of Elon, North Carolina
🏠 Consumer Products Class I - Dangerous
The regulators could leak gas, posing a fire hazard.