Recalls in Indiana
Forest River Dynamax Grand Sport GT Recreational Vehicles
The engine pre-heat pump may be improperly installed, causing coolant hose failure.
Abiomed Impella Controllers
The Automated Impella Controller has defects in firmware and software that can affect pressure signal accuracy and cause unreliable signals.
Endo Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Dexmedetomidine HCL in 0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.
Philips Achieva, Ingenia, Intera and MR MRI Systems
A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted.
12 productsFresenius Medical Care CombiSet Hemodialysis Blood Tubing Sets
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Maquet PowerLED 300 Concealed Lighting System
The PowerLED 300 Concealed Lighting System can detach at the junction between the spring arm and suspension arm and fall, causing potential injury.
CooperSurgical INCA Infant Nasal CPAP Sets
The INCA Infant Nasal CPAP Complete Set may have a loose tubing connection, causing loss of pressure and reduced oxygenation.
2 productsMidmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
4 productsOlympus BiCOAG Hemostasis Probe
The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.
4 productsWinnebago Arka (2027)
Winnebago Arka recreational vehicles have an incorrect rear Gross Axle Weight Rating and cold tire inflation, which can cause tire overload and a crash.
Volvo 9700 buses
Volvo 9700 buses have an emergency exit label missing operating instructions, which may delay exit and increase injury risk.
REV: American Dream (2025-2026), Fleetwood Discovery LXE (2026-2027), Fleetwood Palisade (2026), and 1 more
The RoadWatch Safety System may be programmed with incorrect vehicle parameters, impairing electronic stability control.
Esjay Toddler Busy Board Montessori Toys
The toddler busy board toy has red knobs that can detach, posing a deadly choking hazard.
Friedrich KÜHL Q and KÜHL S Window Air Conditioners
The control board inside the motor of these air conditioners can fail, posing a risk of serious injury or death from fire and burn hazards.
LANCHEZ Pressure Washers
Pressure washers lack a ground-fault circuit-interrupter and adequate power cord, posing shock and electrocution risks.
Melissa & Doug Lights & Sounds Fire Truck Activity Board
The fire truck activity board can detach, posing a choking hazard.
BedsPick Mattresses
BedsPick Mattresses violate the mandatory flammability standard, posing a risk of serious injury or death from fire.
Sauna360 Tylö Halmstad and Kiruna Hybrid Saunas
The saunas have a bench that can collapse, posing a fall hazard.
Sauna360 Infrared Saunas, Hybrid Infrared Saunas and Infrared Kits
Infrared saunas and kits can short circuit, overheat, and cause fire or burn injuries.
Shein Pull & Chew Montessori Teething Toys
The teething toys violate the toy standard because silicone strings are smaller and longer than permitted, posing a deadly choking hazard.
Basecamp Bicycle Helmets
Basecamp bicycle helmets can fail to protect in a crash, posing a risk of head injury or death.
Toyworld168 Rainbow Mystery Squishy Bun Toys
The squishy bun toys contain water beads that expand too large, posing a deadly ingestion hazard.
Hayward Universal Pool Heaters
Universal pool heaters can produce high levels of carbon monoxide, posing a risk of serious injury or death.
Charbroil Bistro Pro Electric Grills
The Charbroil Bistro Pro Electric Grills can lose fault protection, posing an electric shock hazard.
Hospira Dopamine HCl Injection
Dopamine HCl injection lacks assurance of sterility.
Dechra Veterinary Products Puralube Vet Ointment
Puralube Vet Ointment has cGMP deviations.
CADD Yellow Medication Cassette Reservoir with NRFit Connector
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing.
Jaguar E-Pace (2021-2024), Jaguar F-Pace (2021-2024), Land Rover Defender (2020-2024), and 6 more
The DC-DC converter may malfunction, leading to loss of drive power and exterior lighting.
Lexus RX, Lexus RX Hybrid, Lexus TX, and 3 more (2026)
The front steering knuckles may crack and break, causing a loss of steering control and increasing crash risk.
JKMAX Heated Blankets and Heating Pads
Heated blankets and pads can overheat, posing fire and burn hazards.
Jerify Magnetic Humanoid Toy Sets
The magnetic humanoid toy sets can liberate loose high-powered magnets, posing an ingestion hazard to children.
J. HIGGS Loaded Bacon & Cheddar Potato Chips
J. Higgs Loaded Bacon & Cheddar Potato Chips may contain undeclared soy, posing a risk of serious allergic reaction.
Inventia Healthcare Chlorthalidone Tablets
Chlorthalidone Tablets failed dissolution specifications.
Michelle's Bakery Pumpkin Spice No Bake Cookies
Pumpkin Spice No Bake Cookie has peanuts omitted from the contain statement and eggs listed but not present.
Captus 4000e Thyroid Uptake System
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
Abiomed Impella Controllers
The Automated Impella Controller may have purge cassette recognition issues due to a purge flag component failure.
3 productsMedline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery
Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.
4 productsDatex-Ohmeda Aisys Anesthesia Systems
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.
4 productsStryker Sustainability Solutions Ethicon XCEL Bladeless Trocars
Reusable access port system may crack or seperate during use.
6 productsBoston Scientific StoneSmart Connect Console
The StoneSmart Connect Console has power adapters with higher-than-expected resistance in the electrical grounding path.
Medical Action Blood Culture Collection Kits
Medical Action Blood Culture Collection Kits contain applicators with an open or incomplete seal that may compromise sterility and lead to infection.
3 productsHowmedica Osteonics Orthopaedic Implant Components
Orthopaedic implant components made from aged Uhmwpe may oxidize, causing wear and potential harm.
12 productsHemospray Endoscopic Hemostat
The hemostatic device has an issue with endoscope adherence and inability to spray powder.
Wild Coast Brew Loose-Leaf Teas
The Shadow, The Creator, and The Lover loose-leaf teas contain Ashwagandha root, an unsafe food additive.
3 productsRivian R1S (2022-2027), Rivian R1T (2022-2026), and Rivian R2 (2027)
The rearview camera image may be obstructed by a notification, reducing driver view and increasing crash risk.
Rewaco PUR3 GT (2024-2025), Rewaco PUR3 GT Touring (2024-2026), Rewaco RF1 GT Touring (2024-2026), and 2 more
The rear shock absorbers may loosen, causing loss of vehicle control and crash risk.
Embecta Nano Pro Un-Cannulated Demo Samples
Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
2 productsSo Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert
So Delicious Dairy Free Salted Caramel Cluster Cashewmilk may contain small stones and other hard objects.
Bettergoods Lemon Alfredo Fettuccine
Lemon Alfredo Fettuccine may be contaminated with Listeria, which can cause serious infections.
Taro Nystatin Cream
Nystatin Cream, USP, failed stability specifications.


















































