🏥 Medical Devices Class I - Dangerous
Potential exposure of product to microbial contamination.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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
🏥 Medical Devices Class I - Dangerous
Products do not meet stability criteria and may impact results.
🏥 Medical Devices Class I - Dangerous
Detachment of the Male AIV Adaptor from the Y-Connector.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Potential exposure of product to microbial contamination.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Potential exposure of product to microbial contamination.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
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🏥 Medical Devices Class I - Dangerous
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
🏥 Medical Devices 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.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use