🔍 RecallPedia

All Recalls

95,114 total recalls in our database

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28,983
Food
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17,685
Drugs
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38,779
Medical Devices
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9,667
Consumer Products

R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

Teleflex

🏥 Medical Devices Class I - Dangerous

Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.

Dec 12, 2014 Other Medical Devices Nationwide View Details →

This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.

GE Healthcare

🏥 Medical Devices Class I - Dangerous

At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.

Jan 7, 2015 Diagnostic Equipment Nationwide View Details →

Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

Jan 16, 2015 Diagnostic Equipment Nationwide View Details →

Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

Pulsion Medical

🏥 Medical Devices Class I - Dangerous

Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

Nov 4, 2014 Diagnostic Equipment Nationwide View Details →

Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

Alivecor SFO

🏥 Medical Devices Class I - Dangerous

Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.

Jan 9, 2015 Diagnostic Equipment View Details →

HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System

Intuitive Surgical

🏥 Medical Devices Class I - Dangerous

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Jan 21, 2015 Surgical Instruments View Details →

Hand trucks

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The wheel hub can separate or break and eject pieces during inflation, posing a risk of injury to the consumer and bystanders.

Feb 25, 2015 Other Consumer Products Nationwide View Details →

Brewmaster Ceiling Fans

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The ceiling fan hub holding the blades can separate from the shaft when operating in reverse. If this happens, the fan blades and hub can fall and pose a risk of injury to bystanders.

Feb 24, 2015 Electronics Nationwide View Details →

Safe Step Walk-In Tubs

Oliver Fiberglass Products, of Hohenwald, Tenn.

🏠 Consumer Products Class II - Moderate

The tub's heated seat can get stuck in the "on" position. If a towel or other item is covering the seat of an empty tub, the seat can overheat, posing a burn hazard to consumers.

Feb 24, 2015 Other Consumer Products Nationwide View Details →

Xcelite cable stripping tools

Pressmaster AB, of Sweden

🏠 Consumer Products Class II - Moderate

The tool's plastic end cap can fly off the product with force either during use or while in storage, posing an impact hazard.

Feb 19, 2015 Electronics Nationwide View Details →