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High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Man...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manu...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 0182...
Drugs·1,870 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Dis...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Dis...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
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...
Oral Drugs·26,928 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manu...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
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, K1...
Medical Devices·268 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033...
Medical Devices·98 affected·Sep 3, 2025
High RiskFDA
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, K141...
Medical Devices·286 affected·Sep 3, 2025
High RiskFDA
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, K162...
Medical Devices·1 affected·Sep 3, 2025
High RiskFDA
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, K...
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
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, K...
Medical Devices·2,317 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·300 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·87 affected·Sep 3, 2025
High RiskFDA
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;
Medical Devices·5 affected·Sep 3, 2025
High RiskFDA
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;
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K04...
Medical Devices·46 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
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...
Medical Devices·1,117 affected·Sep 3, 2025
High RiskFDA
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, K1419...
Medical Devices·4 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·53 affected·Sep 3, 2025
High RiskFDA
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...
Medical Devices·174 affected·Sep 3, 2025
High RiskFDA
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, K1628...
Medical Devices·501 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·115 affected·Sep 3, 2025
High RiskFDA
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, K162...
Medical Devices·3 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·313 affected·Sep 3, 2025
High RiskFDA
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;
Medical Devices·8 affected·Sep 3, 2025
High RiskFDA
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, K...
Medical Devices·298 affected·Sep 3, 2025
High RiskFDA
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, K1...
Medical Devices·5 affected·Sep 3, 2025
High RiskFDA
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, K...
Medical Devices·5,067 affected·Sep 3, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical Devices·6 affected·Sep 3, 2025
High RiskFDA
Inpeco S.a.
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Diagnostic Devices·1 affected·Sep 3, 2025
High RiskFDA
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...
Oral Drugs·2,192 affected·Sep 2, 2025
High RiskFDA
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, Distri...
Oral Drugs·0 affected·Sep 2, 2025
High RiskFDA
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,...
Oral Drugs·0 affected·Sep 2, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is...
Cardiac Devices·8 affected·Sep 2, 2025
High RiskFDA
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...
Medical Devices·28 affected·Sep 2, 2025
High RiskFDA
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...
Medical Implants·62 affected·Sep 2, 2025
High RiskFDA
Tas Tematic Foods Inc
Frozen Raw Easy Peel shrimp, IQF, 2-lb bag, 10 bags/case; Generic Brown cardboard box UPC: 021130123223
Seafood·5 affected·Aug 29, 2025
High RiskFDA
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, Pi...
Dairy·127,680 affected·Aug 29, 2025
High RiskFDA
I C F Factory Inc
Vanilla G. Nutt Ice Cream (pint, quart, or half gallon)
Dairy·12 affected·Aug 29, 2025
High RiskFDA
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. Wi...
Injectable Drugs·109,320 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Medical Devices·136,512 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices·616 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Ather...
Surgical Devices·199 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·1,167,120 affected·Aug 29, 2025
High RiskFDA
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 ...
Medical Devices·0 affected·Aug 29, 2025