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High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/...
Medical Devices·106,176 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices·141 affected·Aug 29, 2025
High RiskFDA
Getinge Disinfection Ab
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Medical Devices·902 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (...
Medical Devices·2,304 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 dro...
Medical Devices·958,351 affected·Aug 29, 2025
High RiskFDA
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...
Medical Devices·12,720 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Medical Devices·18,720 affected·Aug 29, 2025
High RiskFDA
Imacor Inc.
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor mod...
Medical Devices·45 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Ather...
Surgical Devices·561 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLI...
Medical Devices·27,072 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CL...
Medical Devices·49,200 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch ...
Medical Devices·15,552 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve,...
Medical Devices·69,936 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser At...
Surgical Devices·173 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices·1,019 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Lase...
Surgical Devices·795 affected·Aug 29, 2025
CriticalFDA
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, Sui...
Oral Drugs·0 affected·Aug 28, 2025
RecallFDA
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Caps...
Oral Drugs·11,909 affected·Aug 28, 2025
RecallFDA
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Caps...
Oral Drugs·11,895 affected·Aug 28, 2025
High RiskFDA
Ascend Laboratories, Llc
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Labo...
Oral Drugs·2,256 affected·Aug 28, 2025
RecallFDA
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Caps...
Oral Drugs·3,384 affected·Aug 28, 2025
RecallFDA
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Caps...
Oral Drugs·9,917 affected·Aug 28, 2025
RecallFDA
Granules Pharmaceuticals Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Caps...
Oral Drugs·11,928 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K...
Medical Devices·586 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
Biograph mMR. Model Number: 10433372.
Medical Devices·27 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio. Model Number: 10276755.
Medical Devices·154 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
Medical Devices·130 affected·Aug 28, 2025
High RiskFDA
Howmedica Osteonics Corp.
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Medical Devices·55 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Medical Devices·3 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Medical Devices·39 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425...
Medical Devices·498 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Vida Fit. Model Number: 11410481.
Medical Devices·41 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra fit. Model Number: 10849580.
Medical Devices·56 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Cima.X (DE). Model Number: 11647158.
Medical Devices·22 affected·Aug 28, 2025
CriticalFDA
Dexcom, Inc.
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: ...
Diabetes Devices·333 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Medical Devices·78 affected·Aug 28, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Smoked Cheddar, 5 lb. loaves, packaged 8 loaves per case
Dairy·364 affected·Aug 27, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Shredded Mozzarella Cheese, 5 lb., shredded in a plastic bag and packed 4 bags per case
Dairy·364 affected·Aug 27, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
1) Middlefield Original Cheese Co-op All Natural Pepper Jack Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per ...
Dairy·364 affected·Aug 27, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Shredded Mozzarella/Provolone Cheese, 5 lbs., packaged in a plastic bag, packed 4 bags per case
Dairy·364 affected·Aug 27, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Original Swiss Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distri...
Dairy·364 affected·Aug 27, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Organic Gouda Cheese, 8 oz., packaged individually in plastic, packed 12 per case
Dairy·364 affected·Aug 27, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
1) Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles, Net Wt. 6 oz., packaged individually in plastic, packed 12 per c...
Dairy·364 affected·Aug 27, 2025
CriticalFDA
Middlefield Original Cheese Cooperative
1) Middlefield Original Cheese Co-op All Natural Mild Cheddar Cheese, 5 lb., packaged as individual loaves wrapped in plastic, packed 2 l...
Dairy·364 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4o...
Drugs·57,837 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue,...
Drugs·15,267 affected·Aug 27, 2025
High RiskFDA
Amerisource Health Services Llc
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging...
Oral Drugs·873 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 o...
Topical Drugs·1,480 affected·Aug 27, 2025