Safety Recalls
RSS ↗17,560 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 4,501–4,550 of 17,560
- Class II
Medical Device Recall · December 11, 2025
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is aCustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
- Unclassified
Consumer Product Recall · December 11, 2025
Yiwu Qiangyao E-Commerce Co., Ltd., dba SKCAIHT Direct, of China
SKCAIHT Children's Little Mermaid CostumesThe children's costumes contain a prohibited phthalate, which violates the federal phthalates ban. Phthalates are toxic if ingested by young children and can cause adverse health effects.
- Unclassified
Vehicle Recall · December 11, 2025
2025 BMW X3Unintended steering wheel movement while the vehicle is stationary increases the risk of an injury and on the road, a crash.
- Unclassified
Consumer Product Recall · December 11, 2025
Zhengzhou Bentuo Trading Co., Ltd., dba BenTalk, of China
YCXXKJ Baby Bath SeatsThe recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious injury or death due to drowning.
- Class II
Food Recall · December 11, 2025
Ukrop's 6" Pound Cake with Buttercream Icing/Confetti NET WT 30 OZ (1.88lb/851g) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91849 5 Ukrop's HomeUndeclared Soy. Label did not include soy, which was used in product.
- Class II
Medical Device Recall · December 11, 2025
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control producCustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
- Class II
Medical Device Recall · December 11, 2025
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: ThCustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
- Unclassified
Consumer Product Recall · December 11, 2025
Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California
Vevor Ice CrushersThe ice crusher can experience a thermal event and ignite, posing a fire hazard.
- Unclassified
Consumer Product Recall · December 11, 2025
Trek Bicycle Corporation, of Waterloo, Wisconsin
Model Year 2026 Trek-branded Domane+ ALR 5, Domane+ ALR 6 AXS, Checkpoint+ SL 6 and Checkpoint+ SL 7 Electric BicyclesThe bolts on the chainring can come loose, causing the chainring to separate from the bike, resulting in a fall or crash hazard to the user.
- Class II
Medical Device Recall · December 11, 2025
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma ImCustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
- Class II
Medical Device Recall · December 11, 2025
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control productCustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
- Class II
Medical Device Recall · December 11, 2025
Applied Medical Resources Corp
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
- Class II
Medical Device Recall · December 11, 2025
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.Potential for microbial contamination.
- Unclassified
Consumer Product Recall · December 11, 2025
Primark US Corp., of Boston, Massachusetts
Little Bear 2-pack Soother ClipThe wooden button on the soother clips can come off, exposing a sharp screw, which can pose choking and laceration hazards.
- Unclassified
Consumer Product Recall · December 11, 2025
Sanven Technology Ltd., dba VEVOR, of Rancho Cucamonga, California
VEVOR Garment SteamersThe steamers can leak or spit hot water, posing a risk of serious burn injury to users and bystanders. The water tank cap can also leak or detach during use, exposing users to hot water.
- Unclassified
Consumer Product Recall · December 11, 2025
Hunan Suihuo E-commerce Co., Ltd., dba BaoD, of China
Uuoeebb Infant WalkersThe recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard. In addition, the infant walkers have leg openings that allow the child to slip down until the child's head can become entrapped, posing a risk of serious injury or death.
- Class II
Medical Device Recall · December 11, 2025
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction CartCustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
- Class II
Food Recall · December 11, 2025
Ukrop's 6" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8" Pound Cake with Buttercream Icing/Red Roses NET WT 44 OZ (2.75lb/1.25kg) UPC 7 2251Undeclared Soy. Label did not include soy, which was used in product.
- Class II
Medical Device Recall · December 11, 2025
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasmaCustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
- Unclassified
Vehicle Recall · December 11, 2025
2024 GMC CANYON, 2025 GMC CANYONAn air bag that deploys improperly increases the risk of injury in a crash.
- Unclassified
Consumer Product Recall · December 11, 2025
Yongkang Luyuan Industrial & Trading Co., Ltd., of China
X-Pro Eagle 40cc Youth ATVs and FRP Sahara 40cc Youth ATVsThe recalled youth ATVs violate the mandatory ATV safety standard. The youth ATVs' mechanical suspension fails to comply with safety requirements, posing a crash hazard. Additionally, the handlebars pose a laceration hazard, if the child rider's body or head impacts the handlebars at high speed. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death.
- Class II
Food Recall · December 11, 2025
Ukrop's 6" Pound Cake with Buttercream Icing/Pink Roses NET WT 44 OZ (2.75lb/1.25kg) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91452 7 Ukrop'sUndeclared Soy. Label did not include soy, which was used in product.
- Class II
Medical Device Recall · December 11, 2025
NexxZr T Multi A3.5 W98-16mm, REF: 745451Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
- Unclassified
Vehicle Recall · December 10, 2025
2026 BLUE BIRD VISION SCHOOL BUSA wheelchair lift that fails increases the risk of injury.
- Class II
Medical Device Recall · December 10, 2025
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
- Class II
Medical Device Recall · December 10, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
SMV DSX New Line, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
- Class II
Medical Device Recall · December 10, 2025
Mazor X robotic guidance system REF: TPL0059Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
- Class II
Medical Device Recall · December 10, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
SMV BodyTrack, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
- Class II
Medical Device Recall · December 10, 2025
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.
- Class II
Medical Device Recall · December 10, 2025
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physiciSome of the Calibration/Output Certificates had the outputs reversed.
- Class II
Medical Device Recall · December 10, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
MAXXUS, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
- Class II
Food Recall · December 10, 2025
Publix Raspberry Coffee Cake, Net Wt. 15 oz. (425g), packaged in an aluminum foil tray and clear plastic clamshell lid with wraparound label, UPC 0-41415-54691-2, Distributed By Publix Supermarkets, IUndeclared allergen - walnuts. Maple Walnut Coffee Cake was incorrectly labeled as Raspberry Coffee Cake and walnuts were not declared on the label.
- Class II
Medical Device Recall · December 10, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
SMV DSI, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
- Class I
Food Recall · December 10, 2025
White Castle Original Sliders, Net Wt. 6.35 oz. (180g), packaged as a 4-count carton, each containing 2-Two Packs. UPC 082988029693, packed 6 cartons per case.Undeclared allergens (milk and soy).
- Unclassified
Vehicle Recall · December 10, 2025
Volkswagen Group of America, Inc.
2025 VOLKSWAGEN TIGUANA deactivated passenger air bag increases the risk of injury during a crash.
- Unclassified
Vehicle Recall · December 10, 2025
2026 BLUE BIRD VISION SCHOOL BUSAn unsecured wheelchair can move during transit, increasing the risk of injury.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product DescDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EDue to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWristDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-basedincrease of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWristDue to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product DescriDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Drug Recall · December 9, 2025
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-bincrease of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWristDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-basincrease of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Food Recall · December 8, 2025
MEAL SIMPLE RED LENTIL DAL SOUP NET WT. 16 OZ (1 LB) 454g UPC 1 97870 07333 0 MADE WITH PRIDE AND CARE FOR H-E-B-, SAN ANTONIO, TEXAS 78204Undeclared Milk. Wrong product in container.
- Class II
Food Recall · December 8, 2025
Goldenroot Lemon Ginger Hibiscus Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32821 4. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.
- Class II
Medical Device Recall · December 8, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. AzurionNine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.