Safety Recalls

15,186 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 2,751–2,800 of 15,186

• Medical Device Recall · December 19, 2025

  ICU Medical, Inc.

  Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

  Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body

  Class II

• Medical Device Recall · December 19, 2025

  Canon Medical System, USA, INC.

  VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

  There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

  Class II

• Medical Device Recall · December 19, 2025

  Siemens Medical Solutions USA, Inc

  SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

  To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

  Class II

• Medical Device Recall · December 19, 2025

  Canon Medical System, USA, INC.

  Alphenix INFX-8000H, interventional fluoroscopic x-ray system

  It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

  Class II

• Medical Device Recall · December 19, 2025

  Tyber Medical

  Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Pla

  The supplier manufactured anatomical left plates with an incorrect thread orientation.

  Class II

• Food Recall · December 19, 2025

  Troemner Farm

  Troemner Family Farm Pfeffernusse Cookies, 6oz and 12oz bags

  undeclared soy, wheat, milk

  Class I

• Medical Device Recall · December 19, 2025

  Siemens Medical Solutions USA, Inc

  NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

  To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

  Class II

• Medical Device Recall · December 19, 2025

  Boston Scientific Corporation

  AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

  Class I

• Medical Device Recall · December 19, 2025

  Siemens Medical Solutions USA, Inc

  NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

  To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

  Class II

• Drug Recall · December 19, 2025

  Zydus Pharmaceuticals (USA) Inc

  traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-

  Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

  Class III

• Medical Device Recall · December 19, 2025

  Boston Scientific Corporation

  *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

  Class I

• Medical Device Recall · December 19, 2025

  Canon Medical System, USA, INC.

  Alphenix INFX-8000V, interventional fluoroscopic x-ray system

  It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

  Class II

• Medical Device Recall · December 19, 2025

  Altruan GmbH

  Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

  Product not cleared by the FDA.

  Class II

• Food Recall · December 19, 2025

  Gregory's Foods, Inc

  Gregory's Foods Bag Full of Cookies, White Chocolate Macadamia Nut, frozen cookie dough. Net Wt 2 lbs 8.5 oz (1148g). UPC 8 30825-00124 7. Keep Frozen. Gregory's Foods, Inc., 1301 Trapp Road, Ea

  Undeclared peanuts.

  Class I

• Medical Device Recall · December 19, 2025

  Canon Medical System, USA, INC.

  Alphenix INFX-8000F, interventional fluoroscopic x-ray system

  It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

  Class II

• Medical Device Recall · December 19, 2025

  Boston Scientific Corporation

  AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

  Class I

• Medical Device Recall · December 19, 2025

  ICU Medical Inc.

  Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

  Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

  Class II

• Medical Device Recall · December 19, 2025

  Canon Medical System, USA, INC.

  VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

  There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

  Class II

• Medical Device Recall · December 18, 2025

  Community Products, LLC

  Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait trainin

  Potential for fraying on the body support strap.

  Class II

• Consumer Product Recall · December 18, 2025

  Amp Fit, Inc., of Middletown, Delaware

  AMP MP2 Smart Fitness Machine

  The arm on the MP2 model of the fitness machine does not lock properly, which can allow the arm to swing unexpectedly, posing a risk of laceration or serious injury.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Pedego, LLC, of Fountain View, California

  Fat Tire Trikes

  The trike frame can develop a hairline fracture near a weld, which can cause the tubes to separate, posing fall and laceration hazards.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Blue Wave Products Inc., of Batavia, Illinois

  Blue Wave brand 48-inch and taller above-ground pools

  The compression strap that surrounds the outside of the pool legs may create a foothold, allowing a child access to the pool, posing a drowning risk.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Online at Amazon.com from April 2025 through September 2025 for about $10.

  Feel The Beard Minoxidil Beard Growth Oil for Men

  The beard serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Changzhou Municipal Sea Metal Products Co. Ltd., of China

  KKL Fabric 9-Drawer Dressers

  The recalled dressers are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Qianshanshiangeerdianzishangwuyouxiangongsi doing business as Angeer-US, of China

  Meaicezli Play Purse Sets

  The children's toy violates the mandatory standard for toys because the toy cell phone contains button cell batteries and the toy tablet contains a lithium coin battery that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

  Unclassified

• Food Recall · December 18, 2025

  CATAO MARKET LLC

  Mini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.

  Undeclared colors FD&C Yellow #5

  Class II

• Food Recall · December 18, 2025

  CATAO MARKET LLC

  Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.

  Undeclared colors FD&C Yellow #5

  Class II

• Drug Recall · December 18, 2025

  Imprimis NJOF, LLC

  Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

  Presence of particulate matter - Glass like particles.

  Class II

• Consumer Product Recall · December 18, 2025

  Sound Around Inc. dba SereneLife Home

  SereneLife brand 48-inch and taller above-ground pools

  Hazard not specified

  Unclassified

• Food Recall · December 18, 2025

  DIRECT SOURCE SEAFOOD LLC

  waterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count per Lb. Net wt. 32oz (2LB). Product is packaged in white flexible plastic pouch with multicolored labeling. UPC is

  Shrimp may be contaminated with Cesium-137 (Cs-137).

  Class II

• Drug Recall · December 18, 2025

  Imprimis NJOF, LLC

  Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

  Presence of particulate matter - Glass like particles.

  Class II

• Drug Recall · December 18, 2025

  Imprimis NJOF, LLC

  Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

  Presence of particulate matter - Glass like particles.

  Class II

• Medical Device Recall · December 18, 2025

  Vascutek, Ltd.

  Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE,

  Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.

  Class II

• Food Recall · December 18, 2025

  CATAO MARKET LLC

  Gacen¿iga Authentic Cuban Loaf Cake Classic (Net Wt. 24 oz (680g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.

  Undeclared colors FD&C Yellow #5

  Class II

• Food Recall · December 18, 2025

  DIRECT SOURCE SEAFOOD LLC

  MARKET 32 by Price Chopper brand, frozen RAW SHRIMP easy peel shell on 26/30 count per pound. Net 16oz. Product is packaged in a clear flexible plastic package with brown label and blue and green prin

  Shrimp may be contaminated with Cesium-137 (Cs-137).

  Class II

• Food Recall · December 18, 2025

  CATAO MARKET LLC

  Mini Gaceniga Authentic Cuban Loaf Cake Classic (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.

  Undeclared colors FD&C Yellow #5

  Class II

• Medical Device Recall · December 18, 2025

  Wilson-Cook Medical Inc.

  Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices a

  Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

  Class II

• Medical Device Recall · December 18, 2025

  Community Products, LLC

  Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.

  Potential for fraying on the body support strap.

  Class II

• Medical Device Recall · December 18, 2025

  Community Products, LLC

  Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.

  Potential for fraying on the body support strap.

  Class II

• Consumer Product Recall · December 18, 2025

  Jiangsu Quanronghe Smart Home Co., Ltd., of China

  17 Stories Furniture 18-Drawer Dressers

  The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazard that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Hefei Juyuan Sporting Development Co., Ltd., of China

  ANNQUAN Power Strips, Models EX-D112-05 and EX-D106-25

  The power strips do not contain supplementary overcurrent protection, which creates a risk of fire if the power strips are overloaded. The resulting fire can cause serious injury or death from smoke inhalation and burns.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Currey & Company, Inc., of Atlanta, Georgia

  Electra Chandelier and Electra Three Tier Chandelier light fixtures

  The component that connects the recalled chandelier light fixture to the ceiling mount is not threaded properly and the fixture can fall unexpectedly, posing a risk of injury from impact.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Shanghai Taiye Furniture Co., Ltd., dba Furnulem, of China

  Furnulem 8-Drawer Dressers

  The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Guangshui Xie Lan Zheng Trading Co., Ltd., dba JOKOSIS, of China

  JOKOSIS Portable Bed Rails

  The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Pacific Cycle Inc., of Madison, Wisconsin

  Schwinn Ovation Bicycle Child Carriers

  The buckles securing the restraints around the child can release during use, posing a fall hazard.

  Unclassified

• Consumer Product Recall · December 18, 2025

  Guangzhoushuoshenghaoyikejiyouxiangongsi, dba TopHomerUS, of China

  TopHomer Pool Drain Covers

  The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.

  Unclassified

• Consumer Product Recall · December 18, 2025

  MiramarLab, of Doral, Florida

  Mamisan Pain Relieving Topical Ointment

  The ointment contains lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The ointment's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

  Unclassified

• Food Recall · December 17, 2025

  ZIYAD BROTHERS IMPORTING

  Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case

  May contain partially hydrogenated oils

  Class II

• Medical Device Recall · December 17, 2025

  Aju Pharm Co., Ltd.

  AlternatiV+ Max Knotless Anchor

  Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  Class II

• Food Recall · December 17, 2025

  Prima Foods International, Inc.

  BarbaCuban 90 Miles to Mojo Marinade, Net Wt 12 oz (355 ml) 12 oz glass bottles,1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 g

  Undeclared Quinine

  Class III