Skip to main content
High RiskFDA
Envisiontec Us Llc
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Medical Devices·795 affected·Jan 6, 2022
High RiskFDA
Philips North America
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Medical Devices·1 affected·Jan 6, 2022
High RiskFDA
Akorn, Inc.
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit...
Injectable Drugs·31,510 affected·Jan 5, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Produc...
Medical Devices·6 affected·Jan 5, 2022
High RiskFDA
Balt Usa, Llc
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainle...
Medical Implants·51 affected·Jan 4, 2022
High RiskFDA
Swap Foods Llc
Everything Swapples, Net Wt. 11.14 OZ, UPC 8 64390 00021 3
Food·248 affected·Jan 3, 2022
High RiskFDA
Philips North America Llc
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5....
Medical Devices·36 affected·Jan 3, 2022
High RiskFDA
Organic By Nature, Inc.
Purim Health Brands EpiGenius Kids Chocolate: Daily Superfood 630 g pouches Suggested Use: Mix approximately three tablespoons with 8-10...
Dairy·6,080 affected·Dec 31, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northsta...
Injectable Drugs·7,400 affected·Dec 31, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva ...
Injectable Drugs·11,450 affected·Dec 31, 2021
High RiskFDA
Rubicon Research Private Limited
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: R...
Oral Drugs·3,684 affected·Dec 31, 2021
High RiskFDA
Remedyrepack Inc.
Metformin 750 mg Extended Release NDC # 70518-2920-00
Drugs·56 affected·Dec 30, 2021
High RiskFDA
G&c Food Distributors & Brokers Inc.
GOUDA CHEESE; INGREDIENTS: CULTURED PASTEURIZED MILK, SALT, ENZYMES, ANNATTO COLOR; Distributed By: G&C Foods; ALLERGEN: MILK; CONTAINS: ...
Dairy·305 affected·Dec 29, 2021
High RiskFDA
G&c Food Distributors & Brokers Inc.
WHITE CHEDDAR CHEESE; INGREDIENTS: CULTURED PASTEURIZED MILK, SALT, ENZYMES; Distributed By: G&C Foods; ALLERGEN: MILK; CONTAINS: 1 BAG; ...
Dairy·305 affected·Dec 29, 2021
High RiskFDA
Remedyrepack Inc.
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: As...
Oral Drugs·716 affected·Dec 29, 2021
High RiskFDA
Aurobindo Pharma Usa Inc.
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Oral Drugs·792 affected·Dec 29, 2021
High RiskFDA
Xtant Medical
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Medical Devices·24 affected·Dec 29, 2021
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
Medical Devices·359,524 affected·Dec 29, 2021
High RiskFDA
Bake Crafters
Bake Crafters - Maple Waffle WG Chicken Sausage Packaged into cardboard containers 126 units per case
Meat & Poultry·162 affected·Dec 28, 2021
High RiskFDA
Relish Foods, Inc. Dba Gourmet Fusion Foods
10 oz. individually wrapped frozen tuna steaks; 4 servings per bag Important: Thaw under refrigeration immediately before use. May c...
Seafood·9,000 affected·Dec 28, 2021
High RiskFDA
Hobbs Medical, Inc.
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush ...
Medical Devices·38,357 affected·Dec 28, 2021
High RiskFDA
Padagis Us Llc
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Dist...
Inhaled / Nasal Drugs·11,868 affected·Dec 27, 2021
High RiskFDA
Viona Pharmaceuticals Inc
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Oral Drugs·238,416 affected·Dec 27, 2021
High RiskFDA
Poppies International Inc
Delizza BELGIAN MINI CHOCOLATE CREAM PUFFS NET WT. 14.1 oz (400g) 30 CREAM PUFFS PRODUCED IN THE US BY DELIZZA INCORPORATED 6610 CORPORAT...
Dairy·2,052 affected·Dec 23, 2021
High RiskFDA
Poppies International Inc
Delizza BELGIAN MINI CREAM PUFFS WHIPPED FILLING MADE WITH FRESH CREAM NET WT 13.2 oz (375g) PRODUCED IN THE US BY DELIZZA INCORPORATED 6...
Dairy·995 affected·Dec 23, 2021
High RiskFDA
Poppies International Inc
taste of Inspirations CREME PUFFS Whipped Cream Filled Pastry NET WT 13.2 OZ (375g) 30ct UPC: 7 25439 99597 9, DISTRIBUTED BY: DZA BRAND...
Dairy·324 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear ma...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imagin...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Hill-rom, Inc.
Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Medical Devices·1,215 affected·Dec 23, 2021
High RiskFDA
Olympus Corporation Of The Americas
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and...
Medical Devices·35 affected·Dec 23, 2021
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Medical Devices·149,646 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonan...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Tec...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic res...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging sy...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance ima...
Medical Devices·17,228 affected·Dec 23, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizo...
Medical Devices·17,228 affected·Dec 23, 2021