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High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Medical Devices·1,585 affected·May 31, 2024
High RiskFDA
Heinens
Heinen's Tuscan Salad Bowl Ingredients: Garbanzo Beans***Disodium EDTA***Arugula, Roasted Corn***Red Bell Pepper, Dried Cranberries***Wal...
Dairy·106 affected·May 30, 2024
High RiskFDA
Tillamook County Creamery Association
Tillamook Colby Jack/Monterey Jack Cheese Slices, item # 651195, net wt. 32oz, total 42 slices per package, refrigerated, packaged in fle...
Dairy·1,149 affected·May 30, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceutic...
Oral Drugs·3,552 affected·May 30, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutical...
Oral Drugs·0 affected·May 30, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutical...
Oral Drugs·0 affected·May 30, 2024
High RiskFDA
Dental Ez Group Star Dental Division
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fi...
Medical Devices·32 affected·May 30, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
Medical Devices·73 affected·May 29, 2024
High RiskFDA
Cardinal Health 200, Llc
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Cat...
Cardiac Devices·17,445 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Medical Devices·7 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
Medical Devices·171 affected·May 29, 2024
High RiskFDA
Cardinal Health 200, Llc
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1...
Medical Devices·13,487 affected·May 29, 2024
High RiskFDA
Integra Lifesciences Corp.
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of ...
Surgical Devices·2 affected·May 29, 2024
High RiskFDA
American Spice Llc
Spice Class brand Ground Cinnamon packed in 7oz and 11oz PET jars
Food·1,224 affected·May 28, 2024
High RiskFDA
Winder Laboratories, Llc
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial La...
Oral Drugs·473 affected·May 28, 2024
High RiskFDA
Consumer Product Partners, Llc
Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger,...
Drugs·1,015 affected·May 28, 2024
High RiskFDA
Denison Pharmaceuticals, Llc
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc.,...
Drugs·113,544 affected·May 28, 2024
High RiskFDA
Artivion, Inc
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepare...
Cardiac Devices·2 affected·May 28, 2024
High RiskFDA
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a...
Medical Devices·1 affected·May 27, 2024
High RiskFDA
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a p...
Medical Devices·1 affected·May 27, 2024
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Medical Devices·13,565 affected·May 27, 2024
High RiskFDA
Synchronicity Spa Inc, Dba Sunte
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity...
Drugs·8,202 affected·May 24, 2024
High RiskFDA
Cue Health Inc
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Medical Devices·56 affected·May 24, 2024
High RiskFDA
Moore Family Cheese Llc
Moore Family Farms and Creamery Cheddar Cheese Curds, 1 pound plastic bags, packaged with white ties
Dairy·65 affected·May 23, 2024
High RiskFDA
Eugia Us Llc
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Phar...
Injectable Drugs·70,125 affected·May 23, 2024
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princ...
Injectable Drugs·13,880 affected·May 23, 2024
High RiskFDA
Alcon Research Llc
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Surgical Devices·230 affected·May 23, 2024
High RiskFDA
Howmedica Osteonics Corp.
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Medical Devices·209 affected·May 23, 2024
High RiskFDA
Howmedica Osteonics Corp.
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Medical Devices·630 affected·May 23, 2024
High RiskFDA
Mexhealth Llc
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados,...
Oral Drugs·20 affected·May 22, 2024
High RiskFDA
Abbott Medical
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Medical Implants·1,198 affected·May 22, 2024
High RiskFDA
Thoratec Switzerland Gmbh
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421,...
Medical Devices·3,425 affected·May 22, 2024
High RiskFDA
Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Medical Implants·5,900 affected·May 22, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65...
Medical Devices·114 affected·May 22, 2024
High RiskFDA
Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Medical Implants·5,900 affected·May 22, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG...
Diagnostic Devices·52,410 affected·May 22, 2024
High RiskFDA
Advance Food International Inc.
Shahzada brand Pulses and Spices; Cinnamon Powder; 7 oz (200g); packaged in clear plastic zip-top bags
Food·120 affected·May 21, 2024
High RiskFDA
Carefusion 303, Inc.
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Medical Devices·168 affected·May 21, 2024
High RiskFDA
Angiodynamics, Inc.
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Medical Devices·1,500 affected·May 21, 2024
High RiskFDA
Genentech, Inc.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Drugs·3,618,858 affected·May 20, 2024
High RiskFDA
Pfizer Inc.
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intr...
Injectable Drugs·220,400 affected·May 20, 2024
High RiskFDA
Pfizer Inc.
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscul...
Injectable Drugs·84,710 affected·May 20, 2024
High RiskFDA
Contract Pharmacal Corporation
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233...
Oral Drugs·14,616 affected·May 20, 2024
High RiskFDA
Best Express Foods, Inc.
Universal Bakery Organic Aussie Bites, 30 oz clamshell container
Food·12,538 affected·May 17, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Product is MACARONI Salad, but the bottom container is mislabeled with the ingredients statement for COLESLAW. Product is refrigerated a...
Produce·12,312 affected·May 17, 2024
High RiskFDA
Once Upon A Farm Pbc
Once Upon a Farm Organic Plant-Rich Meal, Curried Carrots & Beans, 3.5 oz, packed in single serving flexible pouches. Product is distribu...
Frozen Food·95 affected·May 17, 2024
High RiskFDA
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcel...
Oral Drugs·165,678 affected·May 17, 2024
High RiskFDA
Cadwell Industries Inc
Cascade IOMAX Cortical Module, REF: 190296-200
Medical Devices·26 affected·May 17, 2024