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 6,351–6,400 of 17,567

Food Recall · September 3, 2025
New Spirit Naturals Inc.
Meal In A Glass protein powder. 1.05 lbs and 4.5 lbs container. UPC: NA Vanilla, Chocolate and Strawberry flavor.
undeclared allergen ingredient Milk.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Product Code: 722029; 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 Product Codes: (1)722013, (2) 722008; 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 FD20/15 OR Table; Product Code: 722059; 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 FD20/15 OR Table; Model Numbers: 722059; 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 PEAS & CARROTS; 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 until
Product may be contaminated with Listeria monocytogenes.
Class I
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20; Product Code: 722031; 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
Food Recall · September 3, 2025
New Spirit Naturals Inc.
Gluta Plus (Glutathione) 60 capsules/container. UPC: NA
undeclared allergen ingredient Milk.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Model Numbers: 722058; 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 FD20/15; Product Code: 722058; 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, 25 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
Drug Recall · September 3, 2025
Zydus Pharmaceuticals (USA) Inc
Chlorpromazine Hydrochloride Tablets, USP, 10 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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; 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 FD20/10; Model Numbers: 722029; 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
Beckman Coulter Inc.
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Class II
Food Recall · September 3, 2025
New Spirit Naturals Inc.
Ultra Whey Protein Powder; 1.4 lbs and 1.4 lbs. Chocolate flavor UPC: NA
undeclared allergen ingredient Milk.
Class II
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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; Model Numbers: 722039; 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, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08
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, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08
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 Biplane; Model Numbers: (1) 722008, (2) 722013; 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 CV20; Model Numbers: 722031; 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, 50 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
Medical Device Recall · September 3, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; 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
Glenmark Pharmaceuticals Inc., USA
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark
Failed Impurities/Degradation Specifications
Class II
Medical Device Recall · September 2, 2025
Canon Medical System, USA, INC.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures f
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
Class II
Medical Device Recall · September 2, 2025
LeMaitre Vascular, Inc.
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (1
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Class II
Drug Recall · September 2, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapol
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
Vehicle Recall · September 2, 2025
Mazda North American Operations
2025 MAZDA CX-90, 2025 MAZDA CX-70
An inaccurate fuel gauge may result in the vehicle unexpectedly running out of fuel and stalling, increasing the risk of a crash.
Unclassified
Medical Device Recall · September 2, 2025
Berkeley Advanced Biomaterials, LLC
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities
Due to incorrect product label (Incorrect product name identified on outer packaging).
Class II
Drug Recall · September 2, 2025
AvKARE
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski,
Failed Content Uniformity Specifications
Class II
Drug Recall · September 2, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (O
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
Vehicle Recall · September 2, 2025
PACCAR Incorporated
2024 KENWORTH T680, 2024 KENWORTH T880, 2025 KENWORTH T880
An instrument panel display that does not show critical information, such as warning lights or vehicle speed, increases the risk of a crash.
Unclassified
Medical Device Recall · August 29, 2025
ConvaTec, Inc
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas s
Wound dressing may have foreign matter on the product.
Class II
Medical Device Recall · August 29, 2025
Northeast Scientific Inc.
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, i
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
IV sets may leak.
Class II
Vehicle Recall · August 29, 2025
Altec Industries, Inc.
2023 ALTEC AERIAL DEVICE
A cable step that fails during use increases the risk of injury.
Unclassified
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Pr
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Northeast Scientific Inc.
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class II
Medical Device Recall · August 29, 2025
Northeast Scientific Inc.
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, inclu
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Northeast Scientific Inc.
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includin
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class II
Medical Device Recall · August 29, 2025
Northeast Scientific Inc.
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includin
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class II
Food Recall · August 29, 2025
I C F Factory Inc
Vanilla G. Nutt Ice Cream (pint, quart, or half gallon)
May contained undeclared almond
Class II