Recalls in Colorado
Philips Incisive CT with Software V4.5&V5.0
Philips Incisive CT may fail to trigger a clinical scan during Bolus Tracking.
Hollister Onli Hydrophilic Urethral Intermittent Catheters
The Onli 17cm Hydrophilic Urethral Intermittent Catheter may have a protrusion that could cause genitourinary trauma or bleeding.
Kia EV9 Vehicles
The Kia EV9 may fail to deactivate the air bag when a child or child seat is in the front passenger seat.
Cornell Pump Enclosed Pump Trailer and Cornell Pump Utility Pump Trailer (2025)
The trailer tongue may crack, causing trailer instability and increasing the risk of a crash.
PACCAR Peterbilt 567, 579, 589 and Kenworth T680, T880, W990 Vehicles
The seat ventilation harness may be missing heat-shrink, causing a short circuit that increases fire risk.
Altec AA Series Aerial Device (2023), Altec AM Series Aerial Device (2025), and 1 more
The vehicles have an improperly calibrated automatic braking system that may delay braking, increasing crash risk.
Pelsue FiberLite Pod Tradesman (2024-2025), Pelsue FiberLite XL Tradesman (2024-2025), and 2 more
The axle mounting bracket may crack and fail, causing a loss of control and increasing the risk of a crash.
Goal Zero YETI 3000X Portable Power Stations
The Yeti 3000X power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.
JINHEZO Mini Waterproof LED Tea Lights
JINHEZO Mini Waterproof LED Tea Lights have accessible button batteries, posing an ingestion hazard that can cause serious injury or death.
Koorlian Mattresses
Koorlian mattresses violate flammability standards, posing a risk of serious injury or death from fire.
GASGAS and Husqvarna Off-Road Motorcycles
Off-road motorcycles have a rear brake caliper that can crack or break, posing a crash hazard.
Airedale Ventilation Fans in ClassMate and SchoolMate Heat Pumps
Ventilation fans in certain heat pumps can short circuit, overheat, and pose a fire hazard.
Boston Scientific ENROUTE Transcarotid Neuroprotection System
The ENROUTE Transcarotid Neuroprotection System has a potential for arterial sheath tip separation during use.
2 products
Rossmonster Baja, Rossmonster Havn, and Rossmonster Skye (2026)
The motorcoaches have a printed circuit board that may overheat, increasing the risk of a fire.
Lucid Air
The Lucid Air has an exterior lighting circuit that can overheat, increasing the risk of a fire.
Britax B-Safe and Endeavours Child Seats
A screw in the child seat carrying handle may come loose, causing the handle to partially detach.
Ford F-650 SD
The Ford F-650 SD has deck pins that may break, causing the liftgate platform to fall and increasing injury risk.
Buick Encore GX (2024-2026), Buick Envista (2024-2025), Chevrolet Trailblazer (2024-2026), and 1 more
The rearview camera in certain Buick and Chevrolet vehicles may display a distorted or blank image, reducing the driver's view and increasing crash risk.
B. Braun Lactated Ringer's Injection
Presence of Particulate matter.
Optimal Balance Pharmacy Glutathione Injection
Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.
Golden State Medical Supply Carbamazepine Tablets
Carbamazepine Tablets, USP, 200mg have black specks due to CGMP deviations.
Mylan Acamprosate Calcium, Delayed-Release Tablets
Acamprosate Calcium, Delayed-Release Tablets failed dissolution specifications.
Esteem Body Soft Convex Urostomy Pouch
Esteem Body Soft Convex Urostomy Pouch may leak from cap during use.
E-One Cyclone and Typhoon Fire Trucks
The hydraulic valve may fail, preventing outrigger operation and delaying emergency response, increasing injury risk.
Avride Automated Driving System
The automated driving system may direct the vehicle to change lanes or veer without yielding, increasing crash risk.
Coast Tropical Jalapeno Pepper
Jalapeno Pepper may be contaminated with Salmonella Javiana.
Taro Carbamazepine Tablets
Carbamazepine tablets may contain black specks from burnt excipient during manufacturing.
Prolon Everyday Apulian Almond & Cocoa Spread
Prolon Everyday Apulian Almond & Cocoa Spread contains undeclared tree nuts that can cause serious allergic reactions.
Gangothri Chicken, Goat, Gongura Chicken, and Gongura Goat Pickle
Ready-to-eat pickled goat and chicken products were produced without benefit of inspection.
4 products
Beckman Coulter DxC 500I Clinical Analyzer Modules
Beckman Coulter DxC 500i Clinical Analyzer Modules have a software defect that can cause erroneous patient test results.
2 productsHolley Street Avenger Carburetor
The Holley Street Avenger Carburetor can cause a loss of throttle control, increasing the risk of a crash.
Heil Front End Loader Garbage Trucks
Front loader garbage trucks with replacement CNG tailgate ladder kits have an incorrect bolt that can damage CNG cylinders, risking a fire.
Heil CNG Tailgate Ladder
An incorrect bolt in the ladder may contact and damage CNG cylinders, causing a fuel leak and fire risk.
Terex C4000, C5000, C6000, and General 65 digger Derrick Trucks
Digger derrick trucks have a cracked weld that may cause the pole guide arm to fall, risking injury.
The Hampton Grocer Lacnola Small Batch Lactation Granola
Lacnola Lactation Granola may be contaminated with Salmonella, which can cause serious infections.
Amneal PEMRYDI RTU (Pemetrexed Injection)
PEMRYDI RTU (pemetrexed injection) has a discolored solution, which can be green to dark green.
2 products
Libtayo (Cemiplimab-Rwlc) Injection
Libtayo (cemiplimab-rwlc) Injection lacks assurance of sterility.
Paragon 28 Navicular Cage Foot Implants
The foot implant has elevated oxygen levels that may reduce material ductility.
2 products
Blanketrol II, Blanketrol III, and Innercool Coolblue Console
The Blanketrol II thermal regulating system may shut down due to overheating of its 115V CPU board.
3 products
Paragonix Technologies KidneyVault Portable Renal Perfusion System
The KidneyVault Portable Renal Perfusion System may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Boston Scientific OverStitch Suture Cinch and Suture Cinch Long
The OverStitch Suture Cinch may fail to deploy the cinch implant or cut the suture.
2 products
Prospector Popcorn Gourmet Popcorn
Prospector Popcorn Chocolate Mocha Gourmet Popcorn has inaccurately declared nutrients, including understated carbohydrates and cholesterol.
4 products
Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device
The TD Navio Midi Speech Generating Device may have damaged battery mounting tabs, causing internal short circuit and heating.
2 products
Kico Knee Innovation Arvis Surgical Navigation System GEN 2
The ARVIS surgical navigation system may show a tilted image due to an internal sensor issue.
Philips Cardiac Workstation 5000 and 7000
The Cardiac Workstation 5000 may provide inaccurate heart rate data.
2 products
Dentsply Sirona Capsule Mixer
The Dentsply Sirona Capsule Mixer can discharge electricity when unplugged.
EndoFLIP System
The EndoFLIP System can incorrectly flag catheters as expired, making them unavailable for clinical procedures.
Horton Type I, Type III, and Critical Care Ambulances
The touchscreen display in these ambulances may fail, preventing activation of exterior emergency lights and other equipment, increasing crash and injury risk.
Shoolin Pharma Chem Sildenafil Citrate and Tadalafil
Sildenafil citrate and tadalafil USP have CGMP deviations noted during FDA inspection.
5 products