2026-08-10 to 2026-08-16
Sources: CPSC, FDA_DEVICE, FDA_FOOD, FDA_DRUG, NHTSA
Other Recalls
The fan blades can separate from the fan motor flywheel, posing impact and injury hazards to consumers.
The recalled youth ATVs violate the mandatory safety standard for ATVs because the parking brakes fail to hold and the ATV's speed limiting device is not set to the restricted speed required for children ages six (6) and older, posing a crash hazard. Additionally, the ATVs are missing the required rear safety reflectors, reducing visibility of the youth ATV to other vehicles, posing a deadly crash hazard.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
The fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act because the closure is not child-resistant, posing a risk of burns and poisoning to children.
During assembly or disassembly, the frame of the wall bed can fall onto consumers, posing deadly impact, crush and laceration hazards.
The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet 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 alloy insert located in the front crown hole of the carbon fork can come loose, causing an accessory to fall off and land on the bike's front wheel, posing a risk of serious injury or death from a fall and crash hazard.
The recalled toys violate the small parts ban because they are intended for children under three years old and the wooden beads pose a deadly choking hazard to young children.
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.
The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards.
The recalled magnetic cubes violate the mandatory standard for toys because the cubes were packaged with loose high-powered 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 fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act. The closure is not child-resistant, posing a risk of burns and poisoning to children.
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
The recalled sound maker violates the mandatory safety standard for consumer products with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard.?Additionally, the packaging and product 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.
Use of the fire pits can result in uncontrolled pool fires where flames burn across the surface of pooled or spilled alcohol, as well as flame jetting from fuel containers, resulting in serious or fatal burns.
The baby jumper, baby swing and 2-in-1 baby jumper & swing can become unstable, posing fall and impact hazards. Additionally, the hanging restraint straps and seat openings can pose strangulation hazards.
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.
The pre-filled fuel containers violate the mandatory safety standards of the Portable Fuel Container Safety Act because they lack flame mitigation devices, posing a deadly risk of flash fire and burn hazard.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Potential for breach in sterile barrier of device packaging.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Potential for breach in sterile barrier of device packaging.
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Due to a defective circuit board that overheats
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Allergen missing from contains statement: fish
Product contaminated with Listeria monocytogenes.
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
Undeclared tadalafil
Product contaminated with Listeria monocytogenes.
Flexible food pouch may release thin plastic strips into food.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Possible Salmonella in Moringa Leaf Powder product.
Product contaminated with Listeria monocytogenes.
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
Product contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
Possible foreign object (thin, soft plastic strands).
Undeclared milk from lactose.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Incorrect Product Formulation
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Potential for breach in sterile barrier of device packaging.
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating.
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Presence of Particulate Matter; identified as stainless steel
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Presence of Particulate Matter; identified as stainless steel
shortfill; reports of empty capsules.
Product contaminated with Listeria monocytogenes.
Product label allergen "contains" statement does not include anchovy(fish)
Product contaminated with Listeria monocytogenes.
During a crash, an incompatible fuel tank cage and fuel system may result in a fuel leak, increasing the risk of a fire.
During a crash, an incompatible fuel tank cage and fuel system may result in a fuel leak, increasing the risk of a fire.
An electrical short can cause a disruption to safety functions such as a loss of rear lighting or instrument panel warning lights, increasing the risk of a crash.
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.
An electrical short can cause a disruption to safety functions such as a loss of rear lighting or instrument panel warning lights, increasing the risk of a crash.