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High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
Medical Devices·116 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Em...
Medical Devices·36 affected·Dec 18, 2024
High RiskFDA
Encore Medical, Lp
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Medical Devices·33 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Medical Devices·8 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100P...
Medical Devices·76 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Medical Devices·17 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, ...
Medical Devices·859 affected·Dec 18, 2024
High RiskFDA
Amerisource Health Services Llc
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Co...
Oral Drugs·2,028 affected·Dec 17, 2024
High RiskFDA
Fdc Limited
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairf...
Ophthalmic Drugs·136,181 affected·Dec 16, 2024
High RiskFDA
Augustine Temperature Management, Llc
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Medical Devices·1 affected·Dec 16, 2024
High RiskFDA
Augustine Temperature Management, Llc
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Medical Devices·4 affected·Dec 16, 2024
High RiskFDA
Integra Lifesciences Corp.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraven...
Medical Implants·132 affected·Dec 16, 2024
High RiskFDA
Mr Bing Foods Inc.
Mr. Bing brand Sriracha Chili Sauce; 9 oz and 18 oz, in clear PET bottle with green cap; UPC 850044819072 and UPC 850044819058
Food·9 affected·Dec 13, 2024
High RiskFDA
Horizon Organic Dairy, Llc
Horizon Organic Aseptic Plain Whole Milk 8OZ 12 Pack. Refrigerate after opening. With the following UPC: 3663207113 (12 pack); 366320712...
Dairy·19,688 affected·Dec 13, 2024
High RiskFDA
Amerisource Health Services Llc
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by...
Oral Drugs·5,178 affected·Dec 13, 2024
High RiskFDA
Hologic, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Diagnostic Devices·380 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software ...
Medical Devices·5,940 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Ver...
Medical Devices·1,980 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Ca...
Medical Devices·3,960 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Numb...
Medical Devices·1,980 affected·Dec 13, 2024
High RiskFDA
Shata Traders Inc.
THREE RIVERS brand TUTTI-FRUTTI; INGREDIENTS Papaya Cubes, Sugar, Citric Acid (E-330), Potassium Sorbate (E-202), FD&C Red #40, FD&C Blue...
Food·86 affected·Dec 12, 2024
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend ...
Oral Drugs·10,444 affected·Dec 12, 2024
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend ...
Oral Drugs·1,971 affected·Dec 12, 2024
High RiskFDA
Livanova Usa, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Medical Devices·81,606 affected·Dec 12, 2024
High RiskFDA
Livanova Usa, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Medical Devices·48 affected·Dec 12, 2024
High RiskFDA
Medtronic Perfusion Systems
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medical Devices·745 affected·Dec 12, 2024
High RiskFDA
Tree House Foods Inc
Great Value, Chicken Broth, 48 oz. , Aseptic paper cartons, 6 retail units per case, 120 cases/pallet .
Meat & Poultry·2,023 affected·Dec 11, 2024
High RiskFDA
Hp Hood (vernon)
WELLSLEY FARM PLAIN NON-FAT GREEK YOGURT; 40 oz; UPC 888670048085
Dairy·15,834 affected·Dec 11, 2024
High RiskFDA
Palermo Villa, Inc
Connie's Classic Thin Crust Cheese Pizza, Chicago's Finest. Net Wt 20.36 oz. (1lb 4.36 oz) 577g. UPC 0 75706-19104 8. Keep Refrigerat...
Dairy·1,728 affected·Dec 11, 2024
High RiskFDA
Hp Hood (vernon)
WELLSLEY FARM VANILLA NON-FAT GREEK YOGURT; 40 oz; UPC 888670048078
Dairy·15,834 affected·Dec 11, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product ...
Oral Drugs·3,888 affected·Dec 11, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product...
Oral Drugs·0 affected·Dec 11, 2024
High RiskFDA
Microvention Inc.
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended p...
Medical Implants·11 affected·Dec 11, 2024
High RiskFDA
Hf Acquisition Co Llc
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring Syste...
Medical Devices·4,021 affected·Dec 11, 2024
High RiskFDA
Better Brands Inc.
Chow Ciao Whole Grain Breaded Broccoli Nuggets - 30 lbs.
Bakery & Grains·168 affected·Dec 10, 2024
High RiskFDA
Summit Import Corporation
Yu Yee, Five Spice Powder,1.76oz
Food·62 affected·Dec 10, 2024
High RiskFDA
Viona Pharmaceuticals Inc
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., ...
Topical Drugs·2,760 affected·Dec 10, 2024
High RiskFDA
Regenerative Processing Plant, Llc
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerati...
Ophthalmic Drugs·170,812 affected·Dec 10, 2024
High RiskFDA
Regenerative Processing Plant, Llc
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: R...
Ophthalmic Drugs·59,275 affected·Dec 10, 2024
High RiskFDA
Viona Pharmaceuticals Inc
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc.,...
Topical Drugs·23,304 affected·Dec 10, 2024
High RiskFDA
Encore Medical, Lp
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Medical Devices·9 affected·Dec 10, 2024
High RiskFDA
Ev3 Inc
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Si...
Surgical Devices·5,189 affected·Dec 10, 2024
High RiskFDA
Riverside Natural Foods, Ltd.
1. Chocolate Drizzled Birthday Cake Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Birthday Cake Granola Bars 4.2oz (5 bars) 3. Cho...
Bakery & Grains·2,408,883 affected·Dec 9, 2024
High RiskFDA
Borsari Food Company Inc
BORSARI Food Company Incorporated; BLOODY MARY MIX ; 32 FL. OZ; INGREDIENTS: Tomato juice, corn syrup, non-fat milk solids, orange juice,...
Dairy·5,818 affected·Dec 9, 2024
High RiskFDA
Riverside Natural Foods, Ltd.
1. Halloween Chocolate Chip Granola Mini Bars 12.6oz (30 bars) 2. Halloween Chocolate Chip Granola Mini Bars 0.42oz
Bakery & Grains·2,408,883 affected·Dec 9, 2024
High RiskFDA
Riverside Natural Foods, Ltd.
1. Chocolate Banana Granola Bars; 5.1oz (6 bars) 2. Chocolate Banana Granola Bars; 0.85oz
Bakery & Grains·2,408,883 affected·Dec 9, 2024
High RiskFDA
Riverside Natural Foods, Ltd.
1.Holiday Sprinkles Chocolate Drizzled Granola Mini Bars 10.5oz (25 bars) 2.Holiday Sprinkles Chocolate Drizzled Granola Mini Bars 0.42oz
Bakery & Grains·2,408,883 affected·Dec 9, 2024
High RiskFDA
Riverside Natural Foods, Ltd.
1.Chocolate Drizzled Vanilla Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Vanilla Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzl...
Bakery & Grains·0 affected·Dec 9, 2024