🔍 RecallPedia

All Recalls

95,050 total recalls in our database

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28,983
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38,779
Medical Devices
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9,603
Consumer Products

FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

BioFire Diagnostics

🏥 Medical Devices Class I - Dangerous

Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.

Mar 7, 2019 Diagnostic Equipment Nationwide View Details →

Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.

Brainlab AG

🏥 Medical Devices Class I - Dangerous

In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.

Feb 27, 2019 Infusion Pumps Nationwide View Details →

Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

Medrobotics

🏥 Medical Devices Class I - Dangerous

The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.

Jan 25, 2019 Surgical Instruments Nationwide View Details →

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

Philips Medical Systems Nederlands

🏥 Medical Devices Class I - Dangerous

Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.

Feb 19, 2019 Diagnostic Equipment Nationwide View Details →

BIOPHEN UFH Control C1, REF 224101

Aniara Diagnostica

🏥 Medical Devices Class I - Dangerous

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

Mar 19, 2019 Other Medical Devices View Details →