Safety Recalls

RSS ↗

15,200 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

All

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 4,751–4,800 of 15,200

Drug Recall · August 29, 2025
Fagron Compounding Services
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Lack of Assurance of Sterility
Class II
Medical Device Recall · August 29, 2025
Northeast Scientific Inc.
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. 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
Baxter Healthcare Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
IV sets may leak.
Class II
Food Recall · August 29, 2025
ROLLING PIN BAKING COMPANY LLC
Rolling Pin brand Dubai Style Chocolate; 17.64 oz stand up pouch; Ingredients: Sugar, Cocoa Butter, Vegetable Fats, Whole Milk Powder, Pistachio (Tree Nut), Skimmed Milk Powder, Cocoa Mass, Kunefa, So
Product does not declare wheat in the allergen statement.
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
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
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
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, 14-inch (35 centimeters), Product Code 2C8632
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
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
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
Food Recall · August 29, 2025
Herbal Creations USA
Bulk packaged Colustrum Powder. packaged with generic product label.
Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.
Class II
Medical Device Recall · August 29, 2025
Fresenius Medical Care Holdings, Inc.
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
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
Food Recall · August 29, 2025
Tas Tematic Foods Inc
Frozen Raw Easy Peel shrimp, IQF, 2-lb bag, 10 bags/case; Generic Brown cardboard box UPC: 021130123223
Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed.
Class II
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
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
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 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
BigTree Sales Inc.
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.
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
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 2C8541
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Getinge Disinfection Ab
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Class II
Medical Device Recall · August 29, 2025
ImaCor Inc.
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
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
Northeast Scientific Inc.
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. 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
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
Baxter Healthcare Corporation
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
IV sets may leak.
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
Northeast Scientific Inc.
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
IV sets may leak.
Class II
Medical Device Recall · August 29, 2025
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
IV sets may leak.
Class II
Drug Recall · August 28, 2025
Green Lumber Holdings, LLC
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Class I
Drug Recall · August 28, 2025
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20
Failed Impurities/Degradation Specifications:
Class III
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Verio Dot. Model Number: 10684333.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Vida Fit. Model Number: 11410481.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
Consumer Product Recall · August 28, 2025
CT (Foshan) New Energy Technology Co., Ltd. (dba CT-Energy), of China
CT-ENERGY Lithium Coin Battery Chargers with Rechargeable 2032 Batteries
The recalled battery charger violates the mandatory standard for consumer products containing button cell or coin batteries because the charger has lithium coin batteries that can be accessed easily by children. In addition, the coin batteries provided with the battery charger are not in child-resistant packaging, and the packaging does not have the warnings as 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 · August 28, 2025
MTC Trading Company, of San Francisco, California
Party Favors Lite-Up Torches and Mini Laser Pointers
The recalled lite-up torches contain button cell batteries in violation of the mandatory standard for toys and the recalled mini laser pointers contain button cell batteries in violation of the mandatory standard for consumer products because the button cell batteries can be accessed easily by children. Additionally, the laser pointers do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
Unclassified
Medical Device Recall · August 28, 2025
Boston Scientific Corporation
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Class II
Medical Device Recall · August 28, 2025
Vantive US Healthcare LLC
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
Class II
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
BIOGRAPH One (DE). Model Number: 11689172.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
Drug Recall · August 28, 2025
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 m
Failed Impurities/Degradation Specifications:
Class III
Drug Recall · August 28, 2025
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15
Failed Impurities/Degradation Specifications:
Class III
Drug Recall · August 28, 2025
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10
Failed Impurities/Degradation Specifications:
Class III
Consumer Product Recall · August 28, 2025
TTI Outdoor Power Equipment, Inc. (TTIOPE), of Anderson, South Carolina
RYOBI Electric Pressure Washers
The pressure washer's capacitor can overheat and burst, causing parts to be forcefully ejected, posing a risk of serious injury from impact to the user or bystanders.
Unclassified
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Prisma. Model Number: 10849582.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
Biograph mMR. Model Number: 10433372.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I