Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
30,447 detailed records are currently available in this category.
If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16,…
There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no…
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were…
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate…
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16,…
In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage)…
the Instructions for Use (IFU) were inadvertently removed from the kit.
The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement…
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Customer notification that the device may be difficult to open or close.
Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used…
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated…
Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background…
The wheel castor assemblies may be loosening on the stretchers.
The firm is finding that the stretcher chair controllers are moving the chairs involuntarily.
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with…
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a fitness product, not a medical device. DSG removed medical claims from product labels…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
