United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Volvo Trucks North America - Rear Brake Modulators May Short Circuit
A loss of anti-lock brakes and electronic stability control increases the risk of a crash or injury.
HappyGira Recalls Sweetie Baby and Style Life Eleven Baby Loungers Due to Risk o...
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.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufac...
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemo...
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.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanil...
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.
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor ...
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.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menth...
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.
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preser...
Lack of Assurance of Sterility
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Increased rate of out-of-specification endotoxin results.
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
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.
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net ...
Subpotent Drug
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
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.
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials,...
Lack of Assurance of Sterility
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Mentho...
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.
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number:...
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey...
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.
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
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.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Num...
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 ...
Failed Dissolution Specifications
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
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.
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-...
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.
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawber...
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.
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Suga...
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.
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CE...
Due to a quality issue regarding the presence of burr on the finished cervical plate product.