All recalls8,424 total
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Potential for spoilage.
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.
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
Potential foreign material (glass)
Potential foreign material (glass)
June 18, 2026 - Clover Hill Dairy of Mechanicsville, Maryland is expanding their recall to include all Clover Hill Dairy brand cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, f
The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.
The recalled toys violate the small parts ban because they are intended for children under three and the small pacifier poses a deadly choking hazard to young children. In addition, the eyes on the plush bear can detach, also posing a choking hazard.
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.
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; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped. The portable loungers do not have a stand, posing a fall hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.
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 consumers.
The recalled fireworks violate the ban for aerial fireworks devices intended to produce audible effects because they have a pyrotechnic composition that exceeds the federal limit, posing deadly explosion and burn hazards. Overloaded fireworks can result in a greater than expected explosion.
The recalled car seat adapters can fail to properly attach to the stroller, which may allow the car seat to fall, posing a risk of serious injury from a fall hazard.
The recalled children’s pajamas violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn injuries or death.
The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.
Unreported Allergens
Dietary supplement product Vista MAX contains undeclared Yellow#5.
Dietary supplement product Ocular Plus contains undeclared Yellow#5.
Potential contamination with plastic material
Potential contamination with plastic material
Nitrofurans detected in product
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
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.
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.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
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.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Products may not have received adequate sterilization processing.
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.