Recalls in North Carolina
Amneal Pharmaceuticals Estradiol Gel
Estradiol Gel packets may be empty or partially full.
Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits
Labeling was updated to warn against using intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
7 products
Cummins L9 Diesel Engines
Cummins L9 diesel engines can leak fuel and stall, increasing fire and crash risks.
Mack Anthem AN and Pioneer PR Trucks
Mack Anthem and Pioneer vehicles have inaccurate axle load calculations that can reduce braking performance, increasing crash risk.
Volvo Trucks VNL and VNR Trucks
Volvo VNL and VNR vehicles have inaccurate axle load calculations that may reduce braking performance, increasing crash risk.
Ajanta Pharma Ranolazine Extended-Release Tablets
Ranolazine Extended-Release Tablets fail dissolution specifications.
Philips MRI Scanners and Upgrade Kits
Ingenia Blue Seal SE and Blue Seal XE export incorrect diffusion data when using Enhanced MR Dicom format.
12 productsCardinal Health 200 Presource Packs Containing Stryker StrykeFlow PS and AHTO Tube Sets
The tube sets may leak fluid during use, potentially causing a slip and fall.
4 products
American Nitrile Blue Nitrile Patient Examination Gloves
Blue Nitrile Patient examination gloves may have tears, missing fingers, and debris, which can expose people to infectious pathogens or chemical agents.
3 products
United Imaging Computed Tomography and Positron Emission Tomography Systems
The systems have a software problem when Split or Local function is enabled and multiple RIS exams are merged into a single study.
12 productsHeraeus PALACOS Bone Cement Mixing and Application Systems
Palacos R pro bone cement has a potential for monomer liquid leakage.
4 products
EnCor EnCompass Breast Biopsy and Tissue Removal System Console
The breast biopsy system may experience errors that interrupt or prolong the procedure.
McKesson, Alere, Fisher Scientific, and Henry Schein hCG Tests
HCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
4 products
ATC RM900 and RM700 Trailers
RM900 and RM700 trailers have coupler mounting bolts that may loosen, separating the coupler and causing loss of control.
HeartSine Samaritan PAD Public Access Defibrillators
HeartSine samaritan PAD defibrillators were distributed without the required Maintenance Supplement.
Saving Sight Cornea
Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Style Homeware Emerspring Mattresses
Emerspring Mattresses violate flammability standards, posing a fire hazard that can cause serious injury or death.
5Color Children's Bike Helmet and Pads Sets
The 5Color children's bicycle helmet and pads sets fail to meet safety standards and may not protect against head injury.
WinxMatrs Mattresses
WinxMatrs mattresses fail flammability standards, posing a fire risk.
Kesyup-Branded Mattresses
Kesyup mattresses violate flammability standards, posing a fire risk.
NEWDERY Power Banks
NEWDERY power banks can explode or ignite, posing fire and burn hazards.
Love To Dream Portable Sleep Machines with Night Light
The portable sleep machines can overheat if the charger is not compatible, posing fire and burn hazards.
ABC Trading Light-Up Glasses, Headbands and Ties
Light-up children's toys contain easily accessible button cell batteries, posing a deadly ingestion hazard to children.
Aitjunz 8-Drawer Dressers
The dressers are unstable if not anchored, posing tip-over and entrapment hazards that can cause serious injury or death to children.
INMO Air3 Smart Glasses
The left temple of INMO Air3 smart glasses can overheat during extended use, posing a burn hazard.
The Blue Cactus Company Reclining Chair Battery Packs
The battery packs can overheat, posing fire and burn hazards.
Medline Convenience Kits
The kits contain neurological sponges with potential for unexpected variability of endotoxin levels.
5 products
Baxter Pro+ MRS Surfaces for VersaCare
PRO+ MRS Surface for Versacare has an error in its UDI label that may lead to incorrect product identification.
3 products
Land Rover Range Rover Sport Vehicles
The rear subframe may crack, reducing structural integrity and increasing injury risk in a crash.
Chevrolet Silverado 1500 (2016-2017), Chevrolet Silverado 2500 (2016), and 4 more
Air bag inflator end caps may detach or rupture, projecting fragments into the vehicle and increasing injury risk.
Grand Design Reflection Fifth Wheel Recreational Trailers
The auto detect solar controller may select a 24 volt output when the system is designed for 12 volts, damaging circuits.
Cadillac OPTIQ Vehicles
The front windows may fail to reverse when closing, which can pinch a passenger.
Land Rover Defender (2024)
The second-row seat belt may be improperly stitched and fail to restrain an occupant during a crash.
Altec Digger Derrick (2021-2026) and Altec TA Series Aerial Device (2023-2025)
Improper wiring may prevent the boom stow auto-neutral feature from engaging, allowing the truck to be driven with the boom elevated.
Mezzetta Golden Greek Peperoncini
Mezzetta Golden Greek Peperoncini may contain foreign objects, specifically mice.
Berlin Seeds Alfalfa Sprouting Seeds
Alfalfa sprouting seeds may be contaminated with E. coli and Salmonella, which can cause serious infections.
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops
Clear Eyes Redness Relief eye drops lack assurance of sterility.
2 products
AVID Medical Halyard IV Start Kits
Halyard IV Start Kit NON-Sterile may have an open or incomplete seal on the applicator packaging.
2 products
AVID Medical Halyard IV Start Kits
Halyard IV Start Kit NON-Sterile may be contaminated with Aspergillus penicillioides.
Cardioroot Woven Collagen Coated Vascular Graft
The Cardioroot Woven Collagen Coated Vascular Graft failed water permeability acceptance criteria.
Imager II Angiographic Catheters
Imager II Angiographic Catheters may fracture or detach, leading to device fragments remaining or migrating.
Forest River Cedar Creek Fifth Wheel Recreational Trailers
The sleeper sofa in Cedar Creek fifth wheel trailers may block the bunkroom door, delaying exit in an emergency.
Land Rover Range Rover Sport
The Range Rover Sport has a powertrain control module that may be deformed, causing a loss of drive power.
Forest River Dynamax Isata Recreational Vehicles
The bunk mat in these vehicles may be misaligned and unsupported, increasing injury risk.
Forest River Dynamax Isata Recreational Vehicles
The bunk ladder may come loose from the mattress insert, increasing injury risk.
A&D Foods Beef, Pork and Goat Cuts
Raw pork, beef, and goat products were produced without federal inspection and bear a false USDA mark of inspection, making them unsafe to eat.
23 products
Macleods Olanzapine Tablets
Olanzapine Tablets, USP 5 mg, failed impurities and degradation specifications.
Amneal Exenatide Injection
Exenatide Injection prefilled pens may contain no medication due to a defective delivery system.
Cardinal Health 200 Presource Convenience Kits
Presource Convenience Kits contain applicators with open or incomplete seals, which could cause infection.
2 products
The Blood Connection Red Blood Cells, Leukocytes Reduced
Red Blood Cells, Leukocytes Reduced were collected from a donor taking Proscar.
