Safety Recalls
RSS ↗15,200 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 3,951–4,000 of 15,200
- Class I
Medical Device Recall · October 10, 2025
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LFFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class II
Drug Recall · October 10, 2025
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: 35192-043-17CGMP Deviations
- Class II
Drug Recall · October 10, 2025
Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1CGMP Deviations
- Class II
Drug Recall · October 10, 2025
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8CGMP Deviations
- Class I
Medical Device Recall · October 10, 2025
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class I
Food Recall · October 10, 2025
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 seasoninUndeclared allergen - milk
- Class III
Drug Recall · October 10, 2025
Alembic Pharmaceuticals Limited
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic PharmaceutiFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Class III
Drug Recall · October 10, 2025
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Class I
Medical Device Recall · October 10, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124FFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class I
Medical Device Recall · October 10, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114DFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class I
Medical Device Recall · October 10, 2025
Convenience Kit, BREAST HERNIA DYNJ909125GFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class I
Medical Device Recall · October 10, 2025
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTYFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class I
Medical Device Recall · October 10, 2025
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNINGFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class I
Medical Device Recall · October 10, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Class II
Medical Device Recall · October 9, 2025
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 PockDue 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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, UltrasonicGE 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.
- Unclassified
Consumer Product Recall · October 9, 2025
Mom Genius of Alpharetta, Georgia
Mom Genius Retractable Safety GatesThe 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.
- Class III
Drug Recall · October 9, 2025
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 II
Drug Recall · October 9, 2025
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
- Class II
Medical Device Recall · October 9, 2025
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, UltrasonicGE 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
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, X003SR097NMarketed Without an Approved NDA/ANDA
- 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
Medical Device Recall · October 9, 2025
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 VDue to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- Unclassified
Consumer Product Recall · October 9, 2025
Guangzhou Jiguang Lighting Co. Ltd., of Guangzhou, China
Living Glow portable waist fanThe lithium-ion batteries can overheat while charging, posing a fire hazard.
- Class II
Medical Device Recall · October 9, 2025
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 DGE 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.
- Unclassified
Vehicle Recall · October 9, 2025
2023 HARLEY-DAVIDSON RH1250S, 2024 HARLEY-DAVIDSON RH1250SAn upper triple clamp that fractures while the motorcycle is being operated could lead to a loss of control, increasing the risk of a crash.
- Class II
Medical Device Recall · October 9, 2025
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, UltrasonicGE 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 III
Drug Recall · October 9, 2025
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 II
Medical Device Recall · October 9, 2025
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, UltrasonicGE 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
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: 408Due 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 III
Drug Recall · October 9, 2025
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 II
Food Recall · October 9, 2025
Aojia Dried Red Bayberry; packaged in 5.6oz (160g) clear plastic bottle; UPC 6942514920327Product contains undeclared sulfites (7.39mg/serving) and cyclamates
- Unclassified
Consumer Product Recall · October 9, 2025
Bmrwtg LED Tutu SkirtsThe 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.
- Class II
Medical Device Recall · October 9, 2025
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, HearDue 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
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, (BarcCGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
- Class II
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 3-15Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
- Unclassified
Consumer Product Recall · October 9, 2025
Calico Brands, of Ontario, California
Scripto® Premium TorchThe recalled torches violate the requirements of the mandatory safety standard for multipurpose lighters, posing deadly fire and burn hazards to consumers.
- Class II
Medical Device Recall · October 9, 2025
Pivotal Health Solutions, Inc.
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage tableThe 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.
- Unclassified
Consumer Product Recall · October 9, 2025
EcoFlow Technology, Inc., of San Francisco, California
EcoFlow Delta Max 2000 Power StationsThe Power Stations may overheat and ignite, posing a risk of serious burn injury and fire hazard.
- Class II
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 9, 2025
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 LowDue 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
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, UltrasonicGE 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 I
Medical Device Recall · October 9, 2025
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENEThe impacted lot may not meet the required tensile strength specification.
- Class II
Medical Device Recall · October 9, 2025
Pivotal Health Solutions, Inc.
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage tableThe 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.
- Unclassified
Consumer Product Recall · October 9, 2025
Bellabu Bear, of Costa Mesa, California
Bellabu Bear Children's RobesThe 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
ESR HaloLock Wireless Power BanksThe 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
Yiwuyichengmaoyiyouxiangongsi, of China, doing business as Amazon seller Ritons
Generic Magnetic Balls 1000pcsThe 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.