Safety Recalls

17,560 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 5,551–5,600 of 17,560

• Food Recall · October 10, 2025

  Teasdale Foods, Inc.

  Giant/Martin's Crunchy Taco Dinner Kit, Net Wt 9.4 OZ (266g), UPC: 068826757516, DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 Product consists of 12 taco shells, 1 sauce packet, and 1

  Undeclared allergen - milk

  Class I

• Vehicle Recall · October 10, 2025

  Forest River, Inc.

  2026 FOREST RIVER FLAGSTAFF, 2026 FOREST RIVER ROCKWOOD

  Sewer gas that enters the vehicle increases the risk of injury.

  Unclassified

• Food Recall · October 10, 2025

  Teasdale Foods, Inc.

  Casa Mamita Soft Taco Dinner Kit, Net Wt 13.4 OZ (379g), UPC: 4099100318715, DIST. & SOLD EXCLUSIVELY BY: ALDI BATAVIA, IL 60510 Product consists of 10 flour tortillas, 1 sauce packet, and 1 seasonin

  Undeclared allergen - milk

  Class I

• Drug Recall · October 10, 2025

  Endo USA, Inc.

  Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

  Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

  Class III

• Drug Recall · October 10, 2025

  CA BOTANA International, Inc.

  Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17

  CGMP Deviations

  Class II

• Medical Device Recall · October 9, 2025

  Pivotal Health Solutions, Inc.

  Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

  The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

  Class II

• Medical Device Recall · October 9, 2025

  B-K Medical A/S

  bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

  GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

  Class II

• Medical Device Recall · October 9, 2025

  Thoratec LLC

  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software V

  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

  Class II

• Medical Device Recall · October 9, 2025

  B-K Medical A/S

  bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

  GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

  Class II

• Medical Device Recall · October 9, 2025

  B-K Medical A/S

  1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed D

  GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

  Class II

• Medical Device Recall · October 9, 2025

  Thoratec LLC

  Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low

  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

  Class II

• Drug Recall · October 9, 2025

  USV Private Limited

  Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05

  Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

  Class II

• Food Recall · October 9, 2025

  Rong Shing Trading NY Inc

  Aojia Dried Red Bayberry; packaged in 5.6oz (160g) clear plastic bottle; UPC 6942514920327

  Product contains undeclared sulfites (7.39mg/serving) and cyclamates

  Class II

• Medical Device Recall · October 9, 2025

  B-K Medical A/S

  UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

  GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

  Class II

• Drug Recall · October 9, 2025

  STAQ Pharma, Inc.

  Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.

  Labeling: Incorrect or Missing Lot and/or Exp Date

  Class III

• Drug Recall · October 9, 2025

  STAQ Pharma, Inc.

  Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.

  Labeling: Incorrect or Missing Lot and/or Exp Date

  Class III

• Medical Device Recall · October 9, 2025

  Thoratec LLC

  Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, Hear

  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

  Class II

• Medical Device Recall · October 9, 2025

  Glycar SA Pty., Ltd.

  SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

  The impacted lot may not meet the required tensile strength specification.

  Class I

• Medical Device Recall · October 9, 2025

  Thoratec LLC

  Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pock

  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

  Class II

• Medical Device Recall · October 9, 2025

  B-K Medical A/S

  Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

  GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

  Class II

• Consumer Product Recall · October 9, 2025

  Bellabu Bear, of Costa Mesa, California

  Bellabu Bear Children's Robes

  The recalled children's robes violate the mandatory flammability standards for children's sleepwear, posing a risk of burn injuries to children.

  Unclassified

• Consumer Product Recall · October 9, 2025

  Calico Brands, of Ontario, California

  Scripto® Premium Torch

  The recalled torches violate the requirements of the mandatory safety standard for multipurpose lighters, posing deadly fire and burn hazards to consumers.

  Unclassified

• Medical Device Recall · October 9, 2025

  C-RAD POSITIONING AB

  Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 408

  Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.

  Class II

• Medical Device Recall · October 9, 2025

  Pivotal Health Solutions, Inc.

  Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

  The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

  Class II

• Consumer Product Recall · October 9, 2025

  Bmrwtg, of China

  Bmrwtg LED Tutu Skirts

  The recalled LED tutu skirts violate the mandatory standard for consumer products containing button cell or coin batteries because the LED lights connected to the skirts contain lithium coin batteries that can be accessed easily by children. Additionally, the tutu skirts do not have the warnings required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

  Unclassified

• Consumer Product Recall · October 9, 2025

  Yiwuyichengmaoyiyouxiangongsi, of China, doing business as Amazon seller Ritons

  Generic Magnetic Balls 1000pcs

  The recalled 3 mm magnetic ball sets violate the mandatory standard for toys because the magnet sets contain loose magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.

  Unclassified

• Drug Recall · October 9, 2025

  ibspot

  Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N

  Marketed Without an Approved NDA/ANDA

  Class II

• Medical Device Recall · October 9, 2025

  B-K Medical A/S

  bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

  GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

  Class II

• Drug Recall · October 9, 2025

  Breckenridge Pharmaceutical, Inc.

  Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc

  CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

  Class II

• Drug Recall · October 9, 2025

  Amerisource Health Services LLC

  Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

  CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

  Class II

• Consumer Product Recall · October 9, 2025

  Waymeet Limited, of Hong Kong

  ESR HaloLock Wireless Power Banks

  The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.

  Unclassified

• Consumer Product Recall · October 9, 2025

  Tempo International (USA) Inc., of Aventura, Florida

  Ambiano Electric Pressure Cookers

  The pressure-cooker lid can be opened before sufficient steam pressure has been released, causing hot contents to escape and posing a risk of burn injuries to consumers.

  Unclassified

• Medical Device Recall · October 9, 2025

  Glycar SA Pty., Ltd.

  SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

  The impacted lot may not meet the required tensile strength specification.

  Class I

• Consumer Product Recall · October 9, 2025

  EcoFlow Technology, Inc., of San Francisco, California

  EcoFlow Delta Max 2000 Power Stations

  The Power Stations may overheat and ignite, posing a risk of serious burn injury and fire hazard.

  Unclassified

• Consumer Product Recall · October 9, 2025

  Guangzhou Jiguang Lighting Co. Ltd., of Guangzhou, China

  Living Glow portable waist fan

  The lithium-ion batteries can overheat while charging, posing a fire hazard.

  Unclassified

• Consumer Product Recall · October 9, 2025

  Mom Genius of Alpharetta, Georgia

  Mom Genius Retractable Safety Gates

  The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate and the floor, posing a risk of serious injury or death due to entrapment.

  Unclassified

• Consumer Product Recall · October 9, 2025

  YGJT Local Warehouse, of China

  YGJT Baby Loungers

  The recalled baby loungers violate the mandatory standard for Infant Sleep Products. The sides are too low to contain an infant. The enclosed openings at the foot of the loungers are wider than allowed, posing a fall and an entrapment hazard to infants. In addition, the baby loungers do not have a stand, posing a fall hazard, if used on elevated surfaces. These violations create an unsafe sleeping environment for infants and can cause death or serious injury to infants.

  Unclassified

• Medical Device Recall · October 9, 2025

  Myofunctional Research Company USA

  Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15

  Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

  Class II

• Drug Recall · October 9, 2025

  STAQ Pharma, Inc.

  FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.

  Labeling: Incorrect or Missing Lot and/or Exp Date

  Class III

• Food Recall · October 9, 2025

  Singh Trading Inc. DBA Roshni Foods

  Roshni Cinnamon Powder, 3.5 oz (100g). This product is packaged in clear plastic pouches.

  Product may contain elevated levels of lead and chromium.

  Class II

• Medical Device Recall · October 8, 2025

  Sterilmed, Inc.

  Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Nu

  Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

  Class II

• Food Recall · October 8, 2025

  Sprouts Farmers Market

  Sprouts Smoked Mozzarella Pasta Salad, RTE Pasta Salad, Refrigerated, 5 day shelf life, packaged into plastic containers at Deli counter and into 16oz plastic grab & go containers, weight dependent on

  Product may contain Listeria monocytogenes.

  Class I

• Drug Recall · October 8, 2025

  ASTRAZENECA PHARMACEUTICALS

  Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.

  Lack of Assurance of Sterility:

  Class II

• Medical Device Recall · October 8, 2025

  Olympus Corporation of the Americas

  Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical devic

  The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

  Class II

• Vehicle Recall · October 8, 2025

  BMW of North America, LLC

  2026 BMW R 1300 RT

  A loss of drive power while riding increases the risk of a crash.

  Unclassified

• Medical Device Recall · October 8, 2025

  Sterilmed, Inc.

  Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/

  Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

  Class II

• Drug Recall · October 8, 2025

  Mohamed Hagar

  Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0

  Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).

  Class I

• Food Recall · October 8, 2025

  Tai Foong USA Inc

  Fusia Asian Inspirations brand Veggie Spring Rolls. Net weight: 10 oz (283.5 g).) retail package identified by UPC 4099100222258. Type of packaging: Paperboard carton with inner poly bag; 12 ct corr

  Undeclared shrimp

  Class I

• Medical Device Recall · October 8, 2025

  Cellavision AB

  REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

  Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.

  Class II

• Food Recall · October 7, 2025

  Del Mar Food Products Corp.

  ORGANIC IQF CHOPPED SPINACH 35 lbs. Net Weight Product is not ready to eat. For food safety, cook to an internal temperature of 165 degrees F as measured with a food thermometer. PACKED BY DEL MAR

  Potential contamination with Listeria monocytogenes.

  Class II