Recalls in California
Padagis Nystatin Cream
Nystatin Cream USP is subpotent, with low assay results from stability testing.
GE Optima XR200amx, XR220amx and XR240amx Radiographic Systems
This could result in patient injury during an exam.
3 products
Sun Pharmaceutical Fexofenadine Hydrochloride Tablets
Fexofenadine Hydrochloride Tablets failed impurities and degradation specifications.
Functional Formularies Organic Whole Foods Meal Replacement Peptide Formulas
The liquid meal replacement formulas may contain less vitamin A than stated.
2 products
Boston Scientific Rapid Refill Continuous Injection System
The Rapid Refill Continuous Injection System contains a syringe that may loosen or disconnect, causing fluid leakage or separation.
ICU Medical Plum Duo Infusion and Solo Precision IV Pump
The Plum Duo Infusion Pump may deliver up to twice the programmed volume in a specific scenario.
2 products
Argon Medical Devices Cardiovascular and Biopsy Trays
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F may not meet sterility release criteria.
6 products
Abiomed Impella Heart Pumps and Introducer Kits
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.
13 products
Olympus Evacuators
Some sterilization parameters may not consistently render the devices adequately sterile.
4 products
NAPA Steering Inner Tie Rod Ends
NAPA steering inner tie rod ends can separate, causing a loss of steering and increasing crash risk.
Grand Design Lineage (2026-2027)
Lineage recreational vehicles have a printed circuit board that may overheat, increasing the risk of a fire.
Zoox Automated Driving Systems
The Zoox Automated Driving System may fail to detect heavy smoke, allowing the vehicle to enter low visibility areas and increasing crash risk.
Intuitive Surgical da Vinci SP Instrument Arm Drape
The da Vinci SP Instrument Arm Drape may detach from the instrument arm, exposing a section and causing procedure delay or conversion.
Insignia Gas Ranges
Insignia gas ranges have front-mounted knobs that can be activated accidentally, posing a fire hazard.
Flaunt MagSafe Battery Chargers
The lithium-ion battery in these power banks can overheat and ignite, posing a risk of serious injury or death from fire and burn hazards.
24V and 48V Kobalt Yard Power Tools with USB-C Batteries
Kobalt 24V and 48V yard power tools with USB-C batteries can short-circuit, posing a risk of serious injury from fire.
Moodooy Adult Portable Bed Rails
Moodooy bed rails can entrap users, posing a risk of serious injury or death from asphyxiation.
WonderStone Infant Walkers
WonderStone Infant Walkers can fit through a standard doorway and fail to stop at a step, posing a risk of serious injury or death.
Versius Surgical System
The Versius Surgical System has a cybersecurity risk because Secure Boot was not enabled.
Think Surgical TMINI Femur and Tibia Tracking Arrays
The TMINI Femur and Tibia Tracking Arrays may loosen at the knob, causing misalignment.
OmniTract Surgical Retractor System
The OmniTract Surgical Retractor System has a dry time that needs to be extended.
GSP Neonatal GALT Kit
The GSP Neonatal GALT Kit may have a stability issue that can delay patient results.
Elekta Brachytherapy Applicators
The Fletcher CT/MR Shielded Applicator Set can detach its intrauterine tube tip, which may remain within a patient.
3 products
Volvo VAH (2026), Volvo VHD (2026), Volvo VN (2026), and 2 more
Volvo VAH, VN, VHD, VNL (4) and VNR (4) vehicles may have loose steering arm fasteners, which can cause loss of steering control.
Somerset Therapeutics Pemetrexed, Bortezomib and Azacitidine for Injection
Pemetrexed, Bortezomib, and Azacitidine for Injection lack sterility assurance.
4 products
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
The assay has a potential for intermittent well-to-well bias.
Medline Convenience Kits
Medline Convenience Kits contain temperature probes with an error in their distribution control process.
3 products
Fresenius Medical Care 5008X Blood Tubing Sets
5008X Blood Tubing Set may have connection issues that can cause online port errors.
Boston Scientific Neuromodulation Intracept Access Instruments
Intracept Access Instruments may have a sterile barrier breach, which could lead to severe infection.
BMW 330e iPerformance (2016-2018), BMW 530e iPerformance (2018-2020), and 2 more
The engine starter relay may corrode and short circuit, increasing the risk of a fire.
GasGas ES 350 (2024), GasGas ES 500 (2024), Husqvarna FE 350S (2022-2024), and Husqvarna FE 501S (2022-2024)
Rear brake calipers on certain Husqvarna and GasGas motorcycles may crack and break, reducing braking ability and increasing crash risk.
Kenworth T680 (2027) and Peterbilt 579 (2026-2027)
The trailer air connection quick release valve may be incorrectly installed, which can cause the trailer to become unstable and increase the risk of a crash.
Forest River Wildwood and Salem Travel Trailers
Wildwood and Salem travel trailers have an incorrect GVWR on the placard, which may lead to overloading and a crash risk.
Lexus TX, Lexus TX Hybrid, Lexus TX Plug-In Hybrid, and 2 more (2026)
The rear axle carriers in certain Lexus and Toyota vehicles may break, causing sudden loss of stability and increasing crash risk.
Utilimaster Velocity (2016, 2019, 2021)
Water may enter an improperly sealed strobe light and cause a short circuit, increasing the risk of a fire.
BMW 2 Series, 3 Series, 4 Series, 5 Series, X3, X4, Z4 and Toyota Supra Vehicles
The engine starter may overheat and catch fire, increasing the risk of injury.
QuVa Pharma Methohexital Sodium
Methohexital Sodium failed impurities and degradation specifications.
Medline Remedy Specialized Silicone Cream (Hydraguard-D)
Medline Remedy Specialized Silicone Cream has formaldehyde levels exceeding specification.
Shimoga Chemicals Clomiphene Citrate Active Pharmaceutical Ingredient
Clomiphene Citrate USP Active Pharmaceutical Ingredient has cGMP deviations.
Beauty Pie Super Healthy Hair Blow Dry Spray
Super Healthy Hair Blow Dry Spray Coconut Water Heat Shield Styler may be contaminated with Pseudomonas aeruginosa.
Avet Methohexital Sodium for Injection
Methohexital Sodium for Injection failed impurities and degradation specifications.
ConvaTec Aquacel Ag Surgical SP
Surgical dressing manufactured out of specification (greater thickness).
Olympus Single Use Distal Cover
The Olympus Single Use Distal Cover has a newly designed replacement version.
Braun Chevrolet Traverse Vehicles
The 2026 Chevrolet Traverse may have a missing braze connection in the fuel fill line, allowing fuel to leak and increasing fire risk.
Kenway 12V LED Towing Light Kits and 12V Submersible Lights
Kenway 12V LED towing light kits and submersible lights may not illuminate properly, reducing trailer visibility and increasing crash risk.
Subaru Ascent (2019-2026), Subaru Crosstrek Hybrid (2026), Subaru Forester (2025-2026), and 1 more
An incorrect GAWR label may lead to an overloaded vehicle, increasing the risk of a crash.
Wabash Econex Refrigerated Body Vehicles
Side door stirrup steps on Econex Refrigerated Body vehicles may detach, increasing injury and crash risk.
Tesla Model 3 (2024) and Tesla Model Y (2026)
Tesla Model Y and Model 3 vehicles may have reduced occupant protections, increasing the risk of injury during a crash.
Fayus Ola-Ola Pounded Yam
OLA-OLA Pounded Yam has undeclared milk, which can cause serious or life-threatening allergic reactions in people with milk allergy.
