Class I - Dangerous
Detachment of the Male AIV Adaptor from the Y-Connector.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Class I - Dangerous
Potential exposure of product to microbial contamination.
Class I - Dangerous
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
Class I - Dangerous
Potential exposure of product to microbial contamination.
Class I - Dangerous
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
WELCH ALLYN, INC/MORTARA
Class I - Dangerous
The radio within the device can become disassociated with the wireless access point.
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Chromsystems Instruments & Chemicals GmbH
Class I - Dangerous
XXX
Class I - Dangerous
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Class I - Dangerous
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Class I - Dangerous
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Randox Laboratories
Class I - Dangerous
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Class I - Dangerous
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Clinical Innovations
Class I - Dangerous
Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
Mani, Inc. - Kiyohara Facility
Class I - Dangerous
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Mani, Inc. - Kiyohara Facility
Class I - Dangerous
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Canon Medical System, USA
Class I - Dangerous
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Class I - Dangerous
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.