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High RiskFDA
Nephron Sterile Compounding Center Llc
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged...
Injectable Drugs·305,895 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 ...
Injectable Drugs·443,483 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, ...
Injectable Drugs·24,870 affected·Feb 22, 2023
High RiskFDA
Baxter Healthcare Corporation
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Medical Devices·16 affected·Feb 22, 2023
High RiskFDA
Sunny Dell, Inc.
Rao's Homemade Roasted Peppers with Portobello Mushrooms Net WT. 12OZ (340g) UPC:74749001106 Packaged in glass jars, 12 packages per cases
Food·221 affected·Feb 21, 2023
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood...
Injectable Drugs·1,212 affected·Feb 21, 2023
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Drugs·13,445 affected·Feb 21, 2023
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Drugs·325,300 affected·Feb 21, 2023
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd E...
Injectable Drugs·8,136 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000...
Medical Devices·363 affected·Feb 21, 2023
High RiskFDA
Preat Corp
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Medical Devices·26 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Ex...
Diagnostic Devices·397 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Medical Devices·3 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for...
Medical Devices·94 affected·Feb 21, 2023
High RiskFDA
Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Medical Devices·277 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room tempe...
Diagnostic Devices·97 affected·Feb 21, 2023
High RiskFDA
Bio-rad Laboratories, Inc.
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Medical Devices·225 affected·Feb 21, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Medical Devices·1,461 affected·Feb 20, 2023
High RiskFDA
Mani, Inc. - Kiyohara Facility
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with...
Medical Devices·45 affected·Feb 20, 2023
High RiskFDA
Moberg Research, Inc.
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, an...
Medical Devices·89 affected·Feb 20, 2023
High RiskFDA
Berner Foods Inc.
Kirkland Signature Colombian Cold Brew Coffee ready-to-drink, 12 fl oz in aluminum can, 12 cans per case
Beverages·231,071 affected·Feb 17, 2023
High RiskFDA
Bindle Bottle
Stainless Steel Water Bottle The product comes in four sizes: 32 oz., 24 oz., 20 oz., and 13 oz.
Beverages·203,523 affected·Feb 17, 2023
High RiskFDA
Raysearch Laboratories Ab
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10....
Medical Devices·10,770 affected·Feb 17, 2023
High RiskFDA
Sheetz Distribution Services, L.l.c.
Sheetz M.T.go! Made To Go Turkey Deli Sandwich. The products are packaged in 4.75 oz. clear, plastic clamshells with the following UPC 75...
Meat & Poultry·10,361 affected·Feb 16, 2023
High RiskFDA
Sheetz Distribution Services, L.l.c.
Sheetz M.T.go!, Made To Go Ham Deli Sandwich. The products are packaged in 4.75 oz. clear, plastic clamshells with the following UPC 759...
Food·5,715 affected·Feb 16, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilizatio...
Medical Devices·45 affected·Feb 16, 2023
High RiskFDA
Catalina Snacks
Fruit flavored ready-to-eat cereal packaged in 1.27 oz. (UPC 850017468214) and 8oz. ( UPC 850017468085) plastic stand up pouch.
Bakery & Grains·316,980 affected·Feb 15, 2023
High RiskFDA
Catalina Snacks
Maple Waffle flavored ready-to-eat cereal packaged in 9oz (UPC 860479001539) plastic stand up pouch.
Bakery & Grains·316,980 affected·Feb 15, 2023
High RiskFDA
Catalina Snacks
Creamy Ranch flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468160) plastic stand up pouch.
Snacks & Candy·316,980 affected·Feb 15, 2023
High RiskFDA
Catalina Snacks
Honey Graham flavored ready-to-eat cereal packaged in 9oz (UPC 860479001553) plastic stand up pouch.
Bakery & Grains·316,980 affected·Feb 15, 2023
High RiskFDA
Catalina Snacks
Cheddar flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468160) plastic stand up pouch.
Snacks & Candy·316,980 affected·Feb 15, 2023
High RiskFDA
Catalina Snacks
Spicy Kick flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468153) plastic stand up pouch.
Snacks & Candy·316,980 affected·Feb 15, 2023
High RiskFDA
Catalina Snacks
Chocolate Peanut Butter flavored ready-to-eat cereal packaged in 9oz (UPC 850017468184) plastic stand up pouch.
Dairy·316,980 affected·Feb 15, 2023
High RiskFDA
Rising Pharmaceuticals
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
Oral Drugs·12,216 affected·Feb 15, 2023
High RiskFDA
Azurity Pharmaceuticals, Inc.
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single d...
Injectable Drugs·16,471 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Merit Medical Systems, Inc.
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Surgical Devices·17 affected·Feb 15, 2023
High RiskFDA
Niagara Bottling
Limited Edition Winter Mint Chocolate Premier Protein 30g Protein High Protein Shake 11.5oz (340mL) UPC 00643843801498 packaged in plasti...
Snacks & Candy·1,152 affected·Feb 14, 2023
High RiskFDA
Pharmedica Usa, Llc
Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 9...
Inhaled / Nasal Drugs·995 affected·Feb 14, 2023
High RiskFDA
Pro-dex Inc
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a d...
Medical Devices·199 affected·Feb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis Med ES Auxiliary (AUX), REF 343
Medical Devices·5,918 affected·Feb 14, 2023
High RiskFDA
Defibtech, Llc
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Cardiac Devices·29 affected·Feb 14, 2023
High RiskFDA
Edwards Lifesciences, Llc
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable L...
Surgical Devices·326 affected·Feb 14, 2023
High RiskFDA
Brainlab Ag
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Medical Devices·56 affected·Feb 14, 2023
High RiskFDA
Fenwal Inc
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Medical Devices·6,564 affected·Feb 14, 2023