🏥 Medical Devices Class I - Dangerous
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Potential risk of brush detachment during cleaning.
🏥 Medical Devices Class I - Dangerous
If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.
🏥 Medical Devices Class I - Dangerous
The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation.
🏥 Medical Devices Class I - Dangerous
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
🏥 Medical Devices Class I - Dangerous
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
🏥 Medical Devices Class I - Dangerous
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
🏥 Medical Devices Class I - Dangerous
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
🏥 Medical Devices Class I - Dangerous
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised¿
🏥 Medical Devices Class I - Dangerous
BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
🏥 Medical Devices Class I - Dangerous
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Sweet Protection brand Ripper Jr., Ripper MIPS Jr., and Ripper MIPS bicycle helmets
Active Brands AS, of Norway
🏠 Consumer Products Class II - Moderate
The bicycle helmets do not comply with the U.S. CPSC federal safety standard for bicycle helmets, posing a risk of head injury.
Lawn dart sets
Crown Darts UK, of United Kingdom
🏠 Consumer Products Class II - Moderate
Lawn darts are banned in the U.S. due to serious risks of skull punctures and other serious injuries, particularly to children.
B-Air, BlueDri, BlueDri Pro and Soleaire Blowers
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The utility outlets on the side of the blowers are not protected by a circuit breaker. If the outlet becomes overloaded or short-circuited, it could overheat, posing a fire hazard.
Thule Sleek strollers
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The stroller's handlebar can detach, posing an injury hazard to children.
Essential Home Belmont 2.0 four-drawer chests
Moveis K1 LTDA, of Brazil
🏠 Consumer Products Class I - Dangerous
The recalled chests are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.