Safety Recalls

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17,567 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 6,301–6,350 of 17,567

Vehicle Recall · September 4, 2025
Chrysler (FCA US, LLC)
2024 DODGE CHARGER EV, 2024 JEEP WAGONEER S, 2025 DODGE CHARGER EV, 2025 JEEP WAGONEER S
A vehicle rollaway increases the risk of a crash.
Unclassified
Drug Recall · September 4, 2025
Zydus Pharmaceuticals (USA) Inc
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Failed Impurity/Degradation Specifications
Class II
Food Recall · September 4, 2025
ONE FROZEN, LLC
Good and Gather brand Southwest-Style Burrito Bowl Blend Processed in a facility that also handles shellfish, egg, fish, milk, sesame, soy, tree nut and wheat ingredients
Product may contain undeclared shrimp (crustacean shellfish).
Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Food Recall · September 4, 2025
Pacific Coast Producers
Halved Pears IN PEAR JUICE FROM CONCNETRATE; NET WT 15 OZ (425 g); Ingredients: Pears, Water, Pear Juice Concentrate; Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603
Potential contamination with heavy metal (Lead).
Class II
Drug Recall · September 4, 2025
Zydus Pharmaceuticals (USA) Inc
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-0
Failed Impurity/Degradation Specifications
Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Basic Biopsy Tray, Item Number NMBP44L
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-2060
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits IHDC30R D AND C PACK
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Medical Device Recall · September 4, 2025
Lutronic Corporation
XERF EFFECTOR 60. Electrosurgical unit.
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Class II
Vehicle Recall · September 4, 2025
Chrysler (FCA US, LLC)
2025 JEEP WAGONEER S
An incorrect cross beam may not adequately protect occupants in a crash, increasing the risk of injury.
Unclassified
Consumer Product Recall · September 4, 2025
Makita U.S.A. Inc., of La Mirada, California
Makita Professional Cordless Grease Guns and Makita Grease Gun Hoses
The flexible grease gun hose can develop a hole allowing grease to be ejected while using the grease gun, posing a laceration hazard.
Unclassified
Consumer Product Recall · September 4, 2025
StopBox USA, of Spokane Valley, Washington
AR-15 Chamber Lock Pro Firearm Locks
A manufacturing defect allows the recalled chamber locks to be forcibly removed, allowing unauthorized or unintended access to the firearm, posing a risk of serious injury or death.
Unclassified
Consumer Product Recall · September 4, 2025
Dong Guan Bo Mo Na Ke Ji You Xian Gong Si, of China, doing business as Pomona
URMYWO Baby Loungers
The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit to secure the infant; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped. The portable loungers do not have a stand, posing a fall hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.
Unclassified
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPARO
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II
Food Recall · September 4, 2025
Pacific Coast Producers
Fruit Cocktail IN 100% JUICE WITH ADDED INGREDIENTS; NET WT 15 OZ (425 g); Ingredients: Diced Peaches, Diced Pears, Water, Grapes, Peach Pulp and Juice, Pineapple Sectors, Pear Juice Concentrate, Halv
Potential contamination with heavy metal (Lead).
Class II
Food Recall · September 4, 2025
Organicare Nature's Science, LLC
FemiClear Daily Bladder Strength Dietary Supplement, 28 Count, UPC 817008020684, SKU FEM50060
Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303.
Class II
Food Recall · September 4, 2025
Pacific Coast Producers
Pears Halves in Pear Juice from Concentrate; NET WT 15 OZ (425 g); Ingredients: Pears, Water, Pear Juice Concentrate; Distributed By: Walmart Inc., Bentonville, AR 72716
Potential contamination with heavy metal (Lead).
Class II
Food Recall · September 4, 2025
Pacific Coast Producers
Pears SLICED in Organic Pear Juice from Concentrate; NET WT 15 OZ (425 g); Ingredients: Organic Pears, Water, Organic Pear Juice Concentrate; Distributed By: Wegmans Food Markets, Inc. Rochester, NY 1
Potential contamination with heavy metal (Lead).
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Class II
Medical Device Recall · September 3, 2025
Inpeco S.A.
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
Class II
Food Recall · September 3, 2025
Zingerman's Coffee Company
Zingerman's Ca$hew Cow Candy Bar net wt 2oz UPC 844397000157
Undeclared peanut
Class I
Medical Device Recall · September 3, 2025
Inpeco S.A.
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Class II
Vehicle Recall · September 3, 2025
Ducati North America
2023 DUCATI PANIGALE V4
A rear wheel axle that breaks while riding can result in a loss of motorcycle control, increasing the risk of a crash or injury.
Unclassified
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Drug Recall · September 3, 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class II
Drug Recall · September 3, 2025
Zydus Pharmaceuticals (USA) Inc
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-0
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Drug Recall · September 3, 2025
Zydus Pharmaceuticals (USA) Inc
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Medical Device Recall · September 3, 2025
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Class II
Food Recall · September 3, 2025
Zingerman's Coffee Company
Zingerman's Peanut Butter Crush Candy Bar net wt 2oz UPC 844397005237
Undeclared cashew
Class I
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Drug Recall · September 3, 2025
Zydus Pharmaceuticals (USA) Inc
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Drug Recall · September 3, 2025
Zydus Pharmaceuticals (USA) Inc
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Class II
Drug Recall · September 3, 2025
Zydus Pharmaceuticals (USA) Inc
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Food Recall · September 3, 2025
New Spirit Naturals Inc.
Super Muscle Support Powder; 300 grams/container UPC: NA
undeclared allergen ingredient Milk.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Class II
Food Recall · September 3, 2025
Endico Potatoes Inc
Endico brand MIXED VEGETABLES; NET WT. 2.5 lbs (40 oz.) (1134 g); KEEP FROZEN UNTIL READY TO USE; Dist. by Endico Potatoes Inc; PRODUCT OF EGYPT; To prepare: Place contents in boiling water. Cook unti
Product may be contaminated with Listeria monocytogenes.
Class I