2026-04-06 to 2026-04-12
Sources: NHTSA, CPSC, FDA_DEVICE, FDA_DRUG, FDA_FOOD
Other Recalls
Incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
The glass can fall out of the frame, increasing the risk of ejection and injury during a crash. Detached window glass can also become a road hazard for other vehicles, increasing the risk of a crash.
Warning lights and a stop sign arm that fail to activate will not warn other drivers the school bus is slowing down, increasing the risk of a crash or injury.
A loss of exterior lights can reduce the visibility of the vehicle to other drivers, increasing the risk of a crash. Inoperative equipment can delay emergency response, increasing the risk of injury.
Air bags that deploy unexpectedly can increase the risk of injury.
A fuel leak increases the risk of a fire.
The fluorescent yellow materials of the boot shell and sole inserts can deteriorate and break, posing a risk of serious injury from a fall.
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.
The recalled male-to-male extension cords violate safety requirements because their exposed prongs can become energized when one end is plugged into a generator or other power source, posing a risk of serious injury and death from electrocution. In addition, using the cords to supply power from a generator to a residential electrical system (backfeeding) poses a risk of electrocution and fire. The cords' short length encourages the use of generators close to homes or enclosed spaces, posing a risk of carbon monoxide (CO) poisoning.
The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings required by Reese's Law. If coin batteries are swallowed, they can cause serious injuries, internal chemical burns and death.
The recalled children's loungewear violates mandatory flammability standards for children's sleepwear, posing a risk of serious injuries or deadly burn hazards to children.
The power connector inside the fan can corrode and cause the fan to overheat, posing a risk of fire.
The dietary supplements contain iron, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the supplements is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
The lithium-ion battery in the recalled pool vacuums can overheat, posing burn and fire hazards to consumers.
The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
If the wires are connected incorrectly, the current limiting resistor can overheat, posing a burn hazard.
The recalled carving kits violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries in the tea lights can be accessed easily by children, posing an ingestion hazard. Additionally, the product and its packaging do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
The recalled steam cleaners' attachments can unexpectedly detach from the steam cleaners and expel hot water or steam onto users during use, posing a serious burn hazard.
The recalled magnetic drinkware charms violate the mandatory standard for magnets because they contain loose magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
The recalled lighters violate the mandatory standard for cigarette lighters because they do not have the required child-resistant mechanism, posing a risk of serious injury or death from fire and burn hazards. In addition, the lighters failed to meet the pre-market lighter submission requirement needed to demonstrate that the lighters feature child-resistant mechanisms and ensuring their safety and compliance with U.S. regulations.
The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
The D-ring handle that is used to unlock the weight pocket from the Buoyancy Compensator Device (BCD) can detach during use. If this happens, the user will not be able to remove the weight pocket in an emergency, in order to rise to the surface, posing a risk of serious injury or death from a drowning hazard.
A child that is not properly restrained during a crash can have an increased risk of injury.
A loss of anti-lock brakes or electronic stability control increases the risk of a crash.
Switch failure may lead to unintentionally working on an energized high voltage battery, increasing the risk of injury or death by electrical shock.
An instrument panel display that fails to show critical safety information, such as gear selection and warning lights, increases the risk of a crash.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Potential for attenuation degradation over time, decreasing the lifespan.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Potential for attenuation degradation over time, decreasing the lifespan.
Surgical light assembly may not adequate support the weight of the ceiling cover.
Potential for attenuation degradation over time, decreasing the lifespan.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Potential for attenuation degradation over time, decreasing the lifespan.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Potential for attenuation degradation over time, decreasing the lifespan.
Fuel pump failure can cause an engine stall, increasing the risk of a crash.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
Undeclared milk.
Salmonella spp. identified in finished product testing
Foreign Object (Glass)
Packaging integrity issue that may compromise product quality .
Foreign Object (Glass)
Packaging integrity issue that may compromise product quality .
Packaging integrity issue that may compromise product quality .
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Packaging integrity issue that may compromise product quality .
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Lack of Assurance of Sterility
Potential for attenuation degradation over time, decreasing the lifespan.
Undeclared sulfites.
Product is potentially under-processed.
Products contain cyclamates (banned sweetener)
Product contains undeclared milk.
The product states wild caught marine collagen and eggshell membrane collagen in ingredient statement but does not state EGG and the specific species of FISH parenthetically or via a Contains statement.
Product is potentially under-processed.
Products contain cyclamates (banned sweetener)
Products contain cyclamates (banned sweetener)
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Potential for attenuation degradation over time, decreasing the lifespan.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Lack of Assurance of Sterility
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Lack of Assurance of Sterility
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Potential for attenuation degradation over time, decreasing the lifespan.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Potential for the balloon in the device to not meet burst specifications.
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Potential for attenuation degradation over time, decreasing the lifespan.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Potential for attenuation degradation over time, decreasing the lifespan.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Potential for attenuation degradation over time, decreasing the lifespan.
Increased risk of purge leaks with Generation 1 purge cassettes.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Without a warning label, the driver may use the altered view to see other vehicles, increasing the risk of a crash.
A detached seat belt anchor will not adequately restrain the seat occupant, increasing the risk of injury in a crash.
Front brake failure increases the risk of crash or injury.
Interference may cause the FCW system to fail, increasing the risk of a crash.
An inability to shift gears reduces the driver's ability to control vehicle speed, increasing the risk of a crash.
A sudden loss of drive power increases the risk of a crash.
An overheated reverse gear control unit increases the risk of a fire.