2026-04-20 to 2026-04-26
Sources: NHTSA, CPSC, FDA_DRUG, FDA_DEVICE, FDA_FOOD
Other Recalls
A generator that operates in an enclosed space, such as a garage, increases the risk of injury or death from carbon monoxide poisoning.
In the event of a crash, an improperly manufactured fuel tank may leak fuel, increasing the risk of a fire.
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the tower's sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
The magnetic stick figures violate the mandatory standard for toys 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 products contain sodium hydroxide (lye), which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child-resistant, posing a risk of chemical burns and irritation to the skin and eyes. The products also violate the labeling requirements for hazardous substances under the Federal Hazardous Substances Act (FHSA).
The recalled tower stools can collapse or tip over while in use and a child's torso can fit through the openings on the tower's sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
The recalled children's toys violate the small parts ban because the toy is intended for children under three years of age?and the fence handles can detach from the toy, posing a deadly choking hazard.
The recalled delivery boxes violate the mandatory standard for consumer products containing button cell and coin batteries because they contain a lithium coin battery that can be easily accessed by children, posing an ingestion hazard. The packaging also does not bear the required warning labels for products containing such batteries as required by Reese's Law. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
The recalled baby loungers violate the mandatory safety standard for?infant support cushions?because the padding can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.
When worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pressure, the socks can pose an injury hazard including burns.
Weight plates can dislodge from the handle during use, posing a risk of serious injury due to impact hazard.
An inverted cooktop flame increases the risk of a fire.
The baby loungers violate the mandatory standard for?infant sleep products?because the sides are shorter than the minimum side height limit to secure the infant and they do not have a stand, posing a fall hazard. Additionally, an infant can fall out of the enclosed opening at the foot of the lounger or become entrapped. Furthermore, the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.
The recalled tower stools can collapse or tip over while in use and a child's torso can fit through the openings on the tower's sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
A loss of anti-lock brakes and electronic stability control increases the risk of a crash or injury.
A loss of anti-lock brakes and electronic stability control increases the risk of a crash or injury.
People in an enclosed space, such as a garage, with a running generator may be at an increased risk of injury or death from carbon monoxide poisoning.
A fuel tank with a dislodged or separated fuel pressure sensor can leak fuel after a rollover crash, increasing the risk of a fire.
An instrument panel display that fails to show critical safety information, such as gear selection and warning lights, increases the risk of a crash.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Wheel stud separation can cause a loss of vehicle control, increasing the risk of a crash.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Increased rate of out-of-specification endotoxin results.
Improperly welded seat brackets can prevent the seat from adequately restraining an occupant during a crash, increasing the risk of injury.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Increased rate of out-of-specification endotoxin results.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.
Chemical contamination: Presence of benzene
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Increased rate of out-of-specification endotoxin results.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Subpotent Drug
Lack of Assurance of Sterility
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Lack of Assurance of Sterility
Chemical contamination: Presence of benzene
Subpotent Drug
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Labelling: Illegible label
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Failed Dissolution Specifications
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Chemical contamination: Presence of benzene
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Subpotent Drug
Subpotent drug
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Chemical contamination: Presence of benzene
Failed Stability Specifications
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Devices which did not meet internal quality specifications were inadvertently distributed.
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Increased rate of out-of-specification endotoxin results.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Increased rate of out-of-specification endotoxin results.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)
Air bags that do not deploy as intended increase the risk of injury in a crash.
A gas spring cylinder rupture or a liftgate falling unexpectedly can increase the risk of injury.
An improperly installed seat belt anchor may fail to properly restrain the driver in a crash, increasing the risk of injury.
An improperly installed seat belt anchor may fail to properly restrain the driver in a crash, increasing the risk of injury.
An unsecured wheelchair can move during transit, increasing the risk of injury.
A loss of drive power increases the risk of a crash.
A damaged tire may cause a loss of vehicle control, increasing the risk of a crash.
Tread separation increases the risk of a crash.