2026-03-09 to 2026-03-15
Sources: NHTSA, CPSC, FDA_DEVICE, FDA_DRUG, FDA_FOOD
Other Recalls
A damaged fuel line may leak, increasing the risk of a fire.
A loose seat may not restrain the occupant as intended, increasing the risk of injury during a crash.
A damaged seat belt or unsecured seat back may not adequately restrain the seat occupant, increasing the risk of injury during a crash.
Reduced capacity may cause the cable to overheat, increasing the risk of a fire.
Starting the vehicle while in gear may cause unexpected vehicle movement, increasing the risk of a crash or injury.
The rivets used to support the swing seat can fail, posing a fall hazard to children.
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 standard as required by the STURDY Act.
The recalled magnet games violate the mandatory standard for toys because they contain loose high-powered magnets that fit within CPSC's small parts cylinder, 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.
A cracked wheel can cause a loss of vehicle control, increasing the risk of a crash.
An open circuit may draw a higher current and increase the risk of a fire.
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
Exhaust fumes inside the cabin increase the risk of injury or death from carbon monoxide poisoning.
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 standard as required by the STURDY Act.
A detached hinge cover can become a road hazard for other vehicles, increasing the risk of a crash.
Loss of the rear ABS system can increase the risk of a crash.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
An audible warning chime that does not properly alert of an unbelted seat belt can increase the risk of injury during a crash.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
CGMP Deviations
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Products contain undeclared milk and soy.
Lack of Assurance of Sterility
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
Stability Data Does Not Support Expiry Date.
Failed Dissolution Specifications
CGMP Deviations
Failed Dissolution Specifications
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Failed Dissolution Specifications
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
CGMP Deviations
Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
CGMP Deviations
CGMP Deviations
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
CGMP Deviations
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations
Potential for rubber fragment detachment during use.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
CGMP Deviations
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Potential for rubber fragment detachment during use.
There is the potential for the length of the trocar shaft to be too long.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
Lack of Assurance of Sterility
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
CGMP Deviations
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
CGMP Deviations
CGMP Deviations
Defective container; inadequately sealed blister packaging.
CGMP Deviations
Products contain undeclared milk and soy.
CGMP Deviations
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Stability Data Does Not Support Expiry Date.
CGMP Deviations
Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Product may contain undeclared peanuts.
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
CGMP Deviations
Contains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Potential contamination with patulin.
Behind-the-ear sound processer packaging label is different then included product.
CGMP Deviations
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
CGMP Deviations
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
CGMP Deviations
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
CGMP Deviations
Stability Data Does Not Support Expiry Date.
Presence of Particulate Matter: Due to production issues
CGMP Deviations
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
A detached carrier can become a road hazard for other vehicles, increasing the risk of a crash or injury.
A detached solar panel can become a road hazard for other vehicles, increasing the risk of a crash.
A door that cannot be opened may trap occupants inside the vehicle, which can increase the risk of injury.
A seat belt buckle that is not latched properly can fail to restrain an occupant in a crash, increasing the risk of injury.
An energized chassis increases the risk of injury and electrocution.