🏥 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.
All Recalls
95,114 total recalls in our database
🏥 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
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
🏥 Medical Devices 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).
🏥 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.
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - 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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Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
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
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
Spacelabs Healthcare
🏥 Medical Devices Class I - Dangerous
During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.
Can-Am® Off-Road screw jacks
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The screw jack can collapse and cause the lifted vehicle to fall on a person, posing a crush hazard that can result in severe injury or death.
Camp Chef portable stoves
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
An internal part of the gas regulator component can have a sharp edge that can wear or tear a hole in the seal causing gas to leak out of the top of the regulator, posing a fire hazard.
Cannondale Canvas NEO Bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The front fender can detach and cause the front wheel to abruptly stop, posing a fall hazard.
🏠 Consumer Products Class II - Moderate
Infant fatalities have been reported with other manufacturers' inclined sleep products, after infants rolled from their back to their stomach or side while unrestrained, or under other circumstances.
LG Chem "RESU 10H" Lithium-Ion Residential Energy Storage System
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The home batteries can overheat, posing a risk of fire and emission of harmful smoke.