Recalls in California
Medtronic NDI Passive Spheres and Biopsy Needle Kit
Medtronic NDI Passive Spheres and Biopsy Needle Kit have variation in reflective material that may affect navigation tracking.
4 products
B Braun SAFSITE Injection Site
The B Braun Safsite Injection Site has a potential for leakage and backflow.
Philips Lumify Diagnostic Ultrasound System
The Philips Lumify Diagnostic Ultrasound System may not recognize transducer registration, prevent scanning, or have unstable connections.
Abbott Amplatzer Amulet Left Atrial Appendage Occluder
The Amplatzer Amulet Left Atrial Appendage Occluder has changes to its instructions regarding risk of pulmonary artery injury.
Alliance RV Valor and Delta Recreational Trailers
The power cord fuse may not provide adequate circuit protection, increasing the risk of a fire.
Forest River Cedar Creek Recreational Trailers
The slide switch in Cedar Creek recreational trailers may lack overcurrent protection, which can cause a fire.
Porsche 911, 718 Cayman and 718 Spyder Vehicles
Center lock wheel bolts may fracture, causing wheel detachment and loss of control.
Axonics PNE Lead Implant Kit
The PNE Lead Implant Kit may leak, break, or experience other issues that may pose a risk to users.
Xalirium Adult Portable Bed Rails
Xalirium Adult Portable Bed Rails can entrap users, posing a risk of serious injury or death from asphyxiation.
Scotch Thermal Laminators
The thermal laminators can overheat, posing a fire hazard.
HatsanUSA Hatsan Blitz and Blitz 777 Air Rifles
Blitz and Blitz 777 air rifles can fire unexpectedly before fully cocked, posing a risk of serious injury or death.
Papablic Bedside Sleepers and Play Yards
The bedside sleepers can displace the mattress, entrapping a baby and posing a deadly suffocation hazard.
Healthmark Vinyl Instrument Guards
Vinyl Instrument Guards have labeling that is not compliant with regulations and updated sterilization instructions.
Merit Medical Systems Scout MD Delivery System
The Scout MD Delivery System may have difficulty deploying, which could prevent the reflector from functioning.
Intelerad IntelePACS and InteleConnect Portal Radiological Image Processing Systems
IntelePACS and InteleConnect Portal/Tech Portal may show report and displayed images that do not match.
Medline Convenience Kits Containing CONMED AirSeal Access Ports
Convenience Kits containing Conmed AirSeal Access Ports may cause delays or ending procedures due to erroneous overpressure alerts and system venting.
6 products
Medline Surgical Convenience Kits
Medline surgical convenience kits contain cannula components that may leak or break during use.
12 products
Beckman Coulter DxU 840m Iris, DxU 850m Iris, IQ200 Sprint Analyzers
The DxU 840m Iris, DxU 850m Iris, IQ200 Sprint, IQ200 Select, and IQ200 Elite may leak lamina fluid, posing slip, chemical.
2 products
Magellan Diagnostics LeadCare II Blood Lead Test Kit
The LeadCare II Blood Lead Test Kit may show a wrong expiration date, causing an error and delayed results.
Radiometer Medical ABL90 FLEX and ABL90 FLEX PLUS Analyzers
The ABL90 Flex and ABL90 Flex Plus analyzers have a risk of potentially inaccurate results.
Microgenics MAS Omni IMMUNE PRO Immunoassay Controls
MAS Omni Immune Pro Liquid Assayed Integrated Immunoassay Control has vial-to-vial variability causing low PTH recovery, which may delay patient PTH results.
Shyft Group Spartan RV Chassis K2 Vehicles
The Spartan RV Chassis K2 has fuel filter hoses that may disconnect, causing a fuel leak and engine stall.
Volvo Trucks VNL Sleeper Cabs
Volvo VNL sleeper cabs may have loose or missing structural bolts, increasing crash injury risk.
Volvo VNL Trucks
Volvo VNL (4) trucks may have loose or missing structural bolts, increasing crash injury risk.
Land Rover Range Rover Vehicles
Water may damage the rearview camera in Land Rover Range Rover vehicles, reducing the driver's view and increasing crash risk.
Prevost H3-45 Buses
Prevost buses are missing the emergency exit operating instruction label, which may delay passenger evacuation and increase injury risk.
American Health Packaging Metoclopramide Tablets
Metoclopramide Tablets may contain foreign tablets or capsules.
Steris Rapicide PA Part A High-Level Disinfectant
Rapicide PA Part A High-Level Disinfectant may swell if its vented cap is blocked, and could expose users to vapor or liquid.
3 products
Ethicon PERMA-HAND Silk Surgical Suture
PERMA-HAND Silk surgical sutures may contain alcohol-based fluid, causing surgical delay or tissue irritation.
PACCAR Peterbilt 567, 579, 589 and Kenworth T680, T880, W900, W990 Vehicles
The sleeper bunk restraint webbing may not be secured properly, increasing the risk of injury in a crash.
Toyota Land Cruiser Hybrid Vehicles
Toyota Land Cruiser Hybrid vehicles have a fuel tube connection that may disconnect and leak fuel, increasing the risk of a fire.
KTM Müller Präzision Steering Dampers for Super Duke R and Super Duke Evo
The steering damper can loosen from the mounting adapter, leading to a loss of steering control.
Par Pharmaceutical Argatroban Injection
Argatroban Injection may contain particulate matter that can cause life-threatening health consequences.
2 products
Zydus Hydrocortisone Sodium Succinate for Injection
Hydrocortisone Sodium Succinate for Injection failed impurities and degradation specifications.
Teva Metoclopramide Tablets
Metoclopramide Tablets, USP, 5 mg may contain foreign tablets or capsules.
Houston Rx Sermorelin and Tirzepatide/Niacinamide Injections
Sermorelin sterile injectable solution lacks process control, and Tirzepatide/Niacinamide injection lacks assurance of sterility.
2 products
Baxter Likorall Overhead Lifts
Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.
BioFire FilmArray Pneumonia and Joint Infection Panels
BioFire Diagnostics is recalling 3 products.
3 products
K.Z. SportTrek Fifth Wheel Recreational Trailers
SportTrek Fifth Wheel recreational trailers have a charge line that may lack circuit protection, risking fire.
Temsa TS35 Coaches
The Temsa TS35 coaches have fuel filter hoses that may disconnect, causing a fuel leak and engine stall.
Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)
The HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.
2 products
Ferno-Washington Power F2 Powered Fastening System
The Power F2 Powered Fastening System may have intermittent loss of powered function, causing reduced performance or delays in patient transport.
Boston Scientific NaviFlex LW Pusher and Advx Panc Stent
The device was incorrectly manufactured with a guidewire exit port, which is not a design feature.
Neuronetics NeuroStar Advanced Therapy Systems
The NeuroStar Advanced Therapy System has cables that are not in conformance with product specifications.
Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312
BD Phoenix Panel NMIC-312 may have quality control failures with Klebsiella pneumoniae.
2 products
JenaValve Trilogy Delivery Catheters
The JenaValve Trilogy Delivery Catheter may have sleeve liner separation that can cause difficulty or inability to deploy the heart valve device.
3 products
Grand Design Imagine Travel Trailers
Grand Design Imagine travel trailers have safety chains that are underrated for their weight, which can cause detachment and a crash.
Genesis G80 and Hyundai Genesis Cars
The front power seat motors may overheat and cause a fire while parked or driving, increasing injury risk.
Lippert Power Seating Assemblies
Power seating assemblies have a power cord fuse that may not provide adequate circuit protection, increasing the risk of a fire.
Grand Design Transcend Travel Trailers
The tire information label on Grand Design Transcend travel trailers may state incorrect tire size and pressure, increasing crash risk.
