Recalls in Nebraska
Recalls of products that were distributed in Nebraska: 567 name Nebraska directly, and 3771 were distributed nationwide.
3895 recalls.
- Boshengya Recalls Rugs Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Carpets and Rugs
Consumer productReported November 12, 2026 · The recalled rugs violate the mandatory standard for the flammability of carpets and rugs, posing a risk of serious injury or death from fire hazard. - Cummins Recalls Portable Generators Due to Risk of Serious Injury from Fire and Burn Hazards
Consumer productReported November 12, 2026 · The valves in the recalled generators were installed incorrectly, preventing fuel vapors from venting properly from the gasoline tank, causing excessive... - Huffy Recalls Buzz Bicycles Cerana T2 E-Trikes Due to Risk of Serious Injury from Fall Hazard
Consumer productReported November 12, 2026 · The recalled tricycles’ rear wheels can become loose or separate from the rear frame, posing a risk of serious injury from a fall hazard. - Kakgold Recalls 4WD Remote-Controlled Car Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported November 12, 2026 · The recalled remote-controlled cars violate the mandatory standard for toys because they contain button cell and lithium-ion batteries in the remote control... - QIOMALA Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards
Consumer productReported November 12, 2026 · The recalled pressure washers lack an adequate-length power cord, which can encourage use of an extension cord, posing a serious risk of injury or death from... - SHEIN Distribution Corporation Recalls Baby Rattle and Teether Toy Sets Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Small Parts Ban
Consumer productReported November 12, 2026 · The recalled toy sets violate the small parts ban because they are intended for children under three years old and the purple and orange knobs can detach from... - Allstar Recalls Sharper Image Tabletop and Infinity Fire Pits Due to Risk of Serious Injury from Burn and Fire Hazards
Consumer productReported November 12, 2026 · Ignited flammable liquid can escape from the recalled fire pits or trigger flame jetting from the fuel containers, posing a risk of serious injury from burn... - Magnetopia Recalls Magnetic Building Cubes and Blocks Due to Risk of Serious Injury or Death from Magnet Ingestion Hazard
Consumer productReported November 5, 2026 · The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to children. When... - U.S. Titan Recalls X-Pro Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash Hazard; Violate Mandatory Standard for ATVs
Consumer productReported November 5, 2026 · The recalled ATVs violate the mandatory ATV safety standard because the speed-adjusting module included with the vehicle allows for the ATV’s speed to be... - Sanven Technology Recalls Vevor BMX Bicycles Due to Risk of Serious Injury or Death from Crash Hazard; Violate Federal Requirements for Bicycles
Consumer productReported November 5, 2026 · The bicycles violate the mandatory safety regulation for bicycles, because they are not equipped with a chain guard. Loose clothing can get entrapped in the... - Baby Brezza Enterprises Recalls SuperFast Sterilizer Dryers Due to Overheating and Burn Hazards
Consumer productReported November 5, 2026 · The recalled sterilizer dryers can overheat when plugged in and operating, posing a risk of injury from a burn hazard if the surface is handled. - Kikea Store Recalls X-VESOLJE Nursing Pillows Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows
Consumer productReported November 5, 2026 · The recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, posing a serious risk... - C.A.M.P. Recalls Mountain Ice Axes Due to Risk of Serious Injury or Death from Fall Hazard
Consumer productReported November 5, 2026 · A screw on the recalled mountain ice axes can loosen during use, causing the handle or pick to detach, posing a risk of serious injury or death from fall... - Gourmia Recalls 9-Slice Digital Air Fryer Ovens Due to Burn Hazard
Consumer productReported November 5, 2026 · The oven’s doors can unexpectedly close when bumped, posing a burn hazard to consumers retrieving hot food. - Jiastfeng Recalls HAUOMS Eight-drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported November 5, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Little Giant Recalls Ladders with Rapid Locks Due to Risk of Serious Injury from Fall Hazard
Consumer productReported November 5, 2026 · The ladders can suddenly retract if the Rapid Locks are not fully engaged, posing a fall hazard to consumers. - Arlopu Recalls Slide Playsets Due to Risk of Serious Injury and Death from Head and Neck Entrapment Hazards
Consumer productReported November 5, 2026 · The recalled products contain multiple openings where a child’s torso can fit through the opening, but a child’s head cannot, posing a risk of serious injury... - Bose Recalls Lithium-Ion Battery Packs for S1 Pro and S1 Pro+ Bluetooth Speaker Systems Due to Risk of Injury from Fire and Overheating Hazards
Consumer productReported November 5, 2026 · The recalled lithium-ion battery packs can overheat and ignite, posing a risk of injury from fire and overheating hazards. - Vanderhall North America Recalls All Model Year 2024-2026 Brawley Electric Recreational Off-road Vehicles Due to Injury and Crash Hazards
Consumer productReported November 5, 2026 · The seat belts in Brawley ROVs can permanently lockup in the fully retracted position. If this occurs, consumers would be unable to reset the seat belt and put... - Orthoscan VERSA Accessory Cart recall (ZIEHM-ORTHOSCAN INC)
Medical deviceClass IIReported November 4, 2026 · The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the... - OmniaSecure Model 3930M recall (Medtronic, Inc.)
Medical deviceClass IIReported November 4, 2026 · Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of... - Boner Bears CHOCOLATE recall (JXK Enterprises, Inc.)
FoodClass IReported November 4, 2026 · JXK Enterprises, Inc is voluntarily recalling Boner Bears Chocolate, Lot #BB21125, after being notified that FDA laboratory analysis confirmed the presence of... - Gluten Free EAT G.A.N.G.S.T.E.R Pizza Crust and Flat Bread Mix recall (GF Blends Inc)
FoodClass IReported November 4, 2026 · Products are recalled due to potential undeclared wheat gluten - Gluten Free Truly AIP Rustic Bread Mix recall (GF Blends Inc)
FoodClass IReported November 4, 2026 · Products are recalled due to potential undeclared wheat gluten - Gluten Free Truly AIP All Purpose Baking Mix Flour 15.3 oz recall (GF Blends Inc)
FoodClass IReported November 4, 2026 · Products are recalled due to potential undeclared wheat gluten - Atorvastatin Calcium Tablets recall (MSN Laboratories Private Limited (Formulations Division, Unit-II))
DrugClass IIReported November 4, 2026 · Presence of Foreign Tablets/Capsules - Theophylline Extended-Release Tablets recall (Brandywine Pharmaceuticals, LLC)
DrugClass IIReported November 4, 2026 · CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory - Theophylline Extended-Release Tablets recall (Brandywine Pharmaceuticals, LLC)
DrugClass IIReported November 4, 2026 · CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory - Vecuronium Bromide for Injection recall (Meitheal Pharmaceuticals, Inc)
DrugClass IIIReported November 4, 2026 · Labeling: Label Lacks Warning or Rx Legend - Vecuronium Bromide for Injection recall (Meitheal Pharmaceuticals, Inc)
DrugClass IIIReported November 4, 2026 · Labeling: Label Lacks Warning or Rx Legend - Lidocaine Ointment USP recall (Direct Rx)
DrugClass IIReported November 4, 2026 · Subpotent Drug - OXYTOCIN recall (Eagle Pharma Outsourcing LLC)
DrugClass IIReported November 4, 2026 · Lack of Assurance of Sterility - PHENYLephrine HCL Infusion recall (Eagle Pharma Outsourcing LLC)
DrugClass IIReported November 4, 2026 · Lack of Assurance of Sterility - ULTRA STRENTGH recall (Fei Fah Medical Manufacturing Pte. Ltd.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Wechem Hand Guard8/1000mL Bag recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - SunCoast Paper Inc. Surgent Antiseptic Hand Soap recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Spurrier recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Chemseptic recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Pro Chem Suds Hand Soap recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - PRO CHEM BAN AID recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - PRO CHEM Fresh Start recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Lynx recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Lynx recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Lynx recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Antiseptic Hand Soap recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Delta Foremost Sani-Foam Mango recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Freshhands Premium Foamy Antibacterial Hand Soap Antiseptic recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Certus Medical Satin Foam recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Aerocare Sani Mango Antiseptic Hand and Body Wash recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - Palm Antiseptic Hand Soap Net Contents: 1 Gallon recall (ABC Compounding Co., Inc.)
DrugClass IIReported November 4, 2026 · CGMP Deviations - ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg recall (Prodose, Inc.)
DrugClass IIIReported November 4, 2026 · Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500... - Carboxymethylcellulose Sodium recall (Huons Co., Ltd.)
DrugClass IIReported November 4, 2026 · Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers - Olmesartan Medoxomil recall (MACLEODS PHARMA USA, INC)
DrugClass IIReported November 4, 2026 · Failed Dissolution Specifications. - Metoclopramide Tablets recall (Safecor Health, LLC)
DrugClass IIReported November 4, 2026 · Manufacturer is recalling batches due to co-mingled tablet. - Abiraterone Acetate Tablets USP 500 mg recall (Glenmark Pharmaceuticals Inc., USA)
DrugClass IIReported November 4, 2026 · Labeling: Not Elsewhere Classified - Formoterol Fumarate Inhalation Solution recall (The Ritedose Corporation)
DrugClass IIReported November 4, 2026 · Failed Impurities/Degradation Specification - Carevo recall (ARJOHUNTLEIGH POLSKA Sp. z.o.o.)
Medical deviceClass IIReported November 4, 2026 · The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling.... - Precision Pointer Electromagnetic recall (Stryker Leibinger GmbH & Co. KG)
Medical deviceClass IIReported November 4, 2026 · Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is... - Nalu TD2 Therapy Disc with firmware recall (Boston Scientific Neuromodulation Corporation)
Medical deviceClass IIReported November 4, 2026 · Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue... - PENTAX Medical Water bottle assembly. Model Number. OS-H5. recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. recall (Pentax of America Inc)
Medical deviceClass IIReported November 4, 2026 · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during... - EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid... recall (BioMerieux SA)
Medical deviceClass IIReported November 4, 2026 · Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater... - Philips Azurion S. Model Number: 722285. recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 M20. Model Numbers: 722079 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 M12. Model Numbers: 722078 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 B20. Model Numbers: 722068 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 7 B12. Model Numbers: 722067 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 5 M20. Model Numbers: 722228 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 5 M12. Model Number: 722227. recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 3 M15. Model Number: 722064 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - Philips Azurion 3 M12. Model Numbers: 722063 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported November 4, 2026 · Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance... - ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported November 4, 2026 · Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis... - ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported November 4, 2026 · Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis... - ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported November 4, 2026 · Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis... - Model Number: 712010. recall (Philips North America)
Medical deviceClass IIReported November 4, 2026 · Potential for the device to fail immediately after an exposure, causing the system to remain stationary. - Impella Connect Optical AIC recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Impella Optical Controller recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Longjili Trading Recalls Pamag Pieeoo Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
Consumer productReported October 29, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - Harkla Recalls Children’s Sensory Swings Due to Risk of Serious Injury from Fall Hazard
Consumer productReported October 29, 2026 · The recalled swings’ ceiling hook can separate from its plate, posing a risk of serious injury from a fall hazard. - Yinklev Recalls Jocoevol 6-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported October 29, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - RootStim Recalls Minoxidil Hair Regrowth Treatment Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging
Consumer productReported October 29, 2026 · The recalled hair regrowth products contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The... - HAIARA Power Banks Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Sold on Amazon.com by Mitrytech
Consumer productReported October 29, 2026 · The power bank’s lithium battery can explode and ignite, posing fire and burn hazards to consumers. - Bodum USA Recalls 5.9 Million French Press Coffee Makers with Replaceable Glass Carafes Due to Risk of Serious Burn Injury
Consumer productReported October 29, 2026 · The carafe can unexpectedly break during use if the glass carafe is damaged or cracked, including by use of a metal spoon to stir the coffee, posing a risk of... - DREO Recalls DR-HSH015 Space Heaters Due to Fire and Burn Hazards
Consumer productReported October 29, 2026 · The recalled space heaters can overheat and ignite, posing fire and burn hazards. - NTI and HTP Brand Gas Boilers Recalled Due to Risk of Serious Injury or Death from Fire, Carbon Monoxide (CO) Poisoning and Impact Hazards; Manufactured by Ariston, formerly NTI Boilers
Consumer productReported October 29, 2026 · The condensate dish inside the boiler can crack during a delayed ignition, allowing unburned gas to build up inside the sealed cabinet. If the gas ignites, the... - Whatever Works Recalls Microwave Grills Due to Risk of Serious Injury or Death from Fire Hazard
Consumer productReported October 29, 2026 · The recalled grills can overheat and ignite, posing a risk of serious injury or death from fire hazard. - SOOWERY Recalls 8-Drawer Fabric Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported October 29, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - PILLANI Recalls Nursing Pillows Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows
Consumer productReported October 29, 2026 · The recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, posing a serious risk... - Fashion Brand Apparel Recalls QZH.DUAO Pajama Sets Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standards for Children’s Sleepwear
Consumer productReported October 29, 2026 · The recalled children’s pajama sets violate the mandatory safety standards for children’s sleepwear, posing a risk of serious burn injuries. - Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog... recall (Greiner Bio-One North America, Inc.)
Medical deviceClass IIReported October 28, 2026 · Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+)... - Medtronic Biopsy Needle Kit recall (Medtronic Navigation, Inc.)
Medical deviceClass IIReported October 28, 2026 · Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect... - Medtronic NDI Passive Spheres REF: 8801075 recall (Medtronic Navigation, Inc.)
Medical deviceClass IIReported October 28, 2026 · Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect... - Medtronic NDI Passive Spheres REF: 8801074 recall (Medtronic Navigation, Inc.)
Medical deviceClass IIReported October 28, 2026 · Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect...