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High RiskFDA
Flathau's Fine Foods
Flathau's Fine Foods Cheese Straws Delta Bred Cheese Straws packaged in 4oz and 6oz cartons 12 packages per case
Dairy·433 affected·Sep 15, 2022
High RiskFDA
Remedyrepack Inc.
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. O...
Oral Drugs·1,699 affected·Sep 15, 2022
High RiskFDA
Cipla
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile ...
Drugs·641,160 affected·Sep 15, 2022
High RiskFDA
Medical Action Industries, Inc. 306
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Cardiac Devices·240 affected·Sep 15, 2022
High RiskFDA
Coca Cola Southwest Beverages Llc
Coca-Cola Classic 12 FL OZ metal Can UPC 04963406 packaged in cardboard 12 pack fridge pack
Food·745 affected·Sep 14, 2022
High RiskFDA
Salon Technologies International Inc
Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle S...
Inhaled / Nasal Drugs·1,656 affected·Sep 14, 2022
High RiskFDA
Baxter Healthcare Corporation
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Medical Devices·29,764 affected·Sep 14, 2022
High RiskFDA
Arrow International Inc.
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For periphe...
Medical Devices·18 affected·Sep 14, 2022
High RiskFDA
Avanos Medical, Inc.
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRO...
Medical Devices·1,378 affected·Sep 14, 2022
High RiskFDA
Luminex Corporation
ARIES SARS-CoV-2 Assay, REF: 50-10047
Diagnostic Devices·5,141 affected·Sep 14, 2022
High RiskFDA
Baxter Healthcare Corporation
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuou...
Medical Devices·1,068,560 affected·Sep 14, 2022
High RiskFDA
Baxter Healthcare Corporation
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal rep...
Medical Devices·524,376 affected·Sep 14, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manu...
Oral Drugs·11,802 affected·Sep 13, 2022
High RiskFDA
Thor Photomedicine Ltd
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Medical Devices·26 affected·Sep 13, 2022
High RiskFDA
Thor Photomedicine Ltd
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Medical Devices·19 affected·Sep 13, 2022
High RiskFDA
Direct Rx
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo,...
Topical Drugs·20 affected·Sep 12, 2022
High RiskFDA
Justified Laboratories
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 ...
Drugs·0 affected·Sep 9, 2022
High RiskFDA
Justified Laboratories
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 ...
Drugs·0 affected·Sep 9, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
Medical Devices·900 affected·Sep 9, 2022
High RiskFDA
Abbott Vascular
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip ...
Cardiac Devices·18,042 affected·Sep 8, 2022
High RiskFDA
Roche Molecular Systems, Inc.
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in l...
Medical Devices·179 affected·Sep 8, 2022
High RiskFDA
Aurora Products, Inc.
Aurora Natural brand; Organic Cranberry Frontier Mix UPC: 6 55852 00730 3; 19 oz (538g); Ingredients: ORGANIC DRIED CRANBERRIES (ORGANIC ...
Dairy·360 affected·Sep 7, 2022
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapp...
Cardiac Devices·91 affected·Sep 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Medical Devices·18 affected·Sep 7, 2022
High RiskFDA
Balt Usa, Llc
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Medical Devices·41 affected·Sep 7, 2022
High RiskFDA
Philips North America Llc
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Medical Devices·115 affected·Sep 6, 2022
High RiskFDA
Luminostics, Inc Dba Clip Health
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Diagnostic Devices·10,037 affected·Sep 2, 2022
High RiskFDA
Superior Glove Works, Ltd.
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are ...
Topical Drugs·7,296 affected·Sep 1, 2022
High RiskFDA
B Braun Medical Inc
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Medical Devices·94,000 affected·Sep 1, 2022
High RiskFDA
Texas Medical Technology Inc.
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Surgical Devices·100,000 affected·Sep 1, 2022
High RiskFDA
Medline Industries, Lp - Northfield
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Medical Devices·1,760 affected·Sep 1, 2022
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Medical Devices·53,624 affected·Sep 1, 2022
High RiskFDA
Omm Imports, Inc. Dba Zero Gravity
Recreo Hair Growth Laser Comb
Medical Devices·1,620 affected·Sep 1, 2022
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Drugs·82,689 affected·Aug 31, 2022
High RiskFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478...
Topical Drugs·48,636 affected·Aug 31, 2022
High RiskFDA
Micro-x Ltd.
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Medical Devices·42 affected·Aug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
Medical Devices·3 affected·Aug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
Medical Devices·38 affected·Aug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
Medical Devices·69 affected·Aug 31, 2022
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Medical Devices·169 affected·Aug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Medical Devices·373 affected·Aug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Medical Devices·10,201 affected·Aug 30, 2022
High RiskFDA
Albertsons Companies Llc
Ready Meals Snow Crab Legs Imitation Surimi SCE NET WT 12 OZ CAL 300 NET WT. 0lb 12oz (340g) ready2eat Ingredients: Fish Protein (one o...
Meat & Poultry·0 affected·Aug 29, 2022
High RiskFDA
Teva Pharmaceuticals Usa Inc
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single E...
Oral Drugs·83,703 affected·Aug 29, 2022
High RiskFDA
Carolina Infusion
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·4 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·348 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·1 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·4 affected·Aug 26, 2022