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CriticalFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100
Medical Devices·1,093,588 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Medical Devices·38,982 affected·Jun 30, 2020
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Medical Devices·152,539 affected·Jun 30, 2020
High RiskFDA
Medline Industries Inc
ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are inte...
Surgical Devices·680 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Medical Devices·17,767 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Medical Devices·7,854 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of ...
Medical Devices·1,442,097 affected·Jun 30, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Medical Devices·1,800 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the ...
Medical Devices·8,558 affected·Jun 30, 2020
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software
Medical Devices·146,224 affected·Jun 30, 2020
High RiskFDA
Philips North America, Llc
IntelliVue MX800 patient monitor, model no. 865240
Medical Devices·28 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Medical Devices·37,141 affected·Jun 30, 2020
RecallFDA
Vitamin Shoppe
The Vitamin Shoppe Calcium Citrate Plus Magnesium & Vitamin D. 100 count (VS-1086; UPC:6653601086), 300 count (VS-1087; UPC: 6653601087),...
Supplements·8,897 affected·Jun 29, 2020
High RiskFDA
Garland Ventures, Ltd Dba Bally Plus
Freshness Guaranteed Five Cheese Stuffed Shells Traditional Italian Ricotta Filled Shells with Marinara Sauce 10.76 ounces UPC 7874235174
Dairy·1,095 affected·Jun 29, 2020
CriticalFDA
Transliquid Technologies, Llc
Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8...
Topical Drugs·20,340 affected·Jun 29, 2020
High RiskFDA
Emd Serono, Inc.
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., R...
Injectable Drugs·30,756 affected·Jun 29, 2020
High RiskFDA
Remedyrepack Inc.
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489...
Oral Drugs·498 affected·Jun 29, 2020
High RiskFDA
Smith & Nephew, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patien...
Medical Devices·3 affected·Jun 29, 2020
High RiskFDA
Boss Instruments, Ltd.
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are s...
Medical Devices·96 affected·Jun 26, 2020
High RiskFDA
Precision Valve & Automation,inc
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motor...
Respiratory Devices·3 affected·Jun 26, 2020
High RiskFDA
Covidien Llc
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp style...
Medical Devices·269 affected·Jun 26, 2020
High RiskFDA
Chuckanut Bay Foods Llc
Red Velvet Layered Cheesecake is one whole cake (9" round cake) that has been pre-sliced into 14 slices and packaged in a white case box....
Dairy·60 affected·Jun 25, 2020
High RiskFDA
Polarized Llc
Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, M...
Drugs·18 affected·Jun 25, 2020
High RiskFDA
Built Brands Llc
Banana Chocolate Creme Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes,...
Snacks & Candy·79,500 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Double Chocolate Mousse Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes...
Snacks & Candy·48,480 affected·Jun 24, 2020
High RiskFDA
Whole Foods Market
Whole Foods Market Red Velvet Layered Cheesecake Slice PLU: 78620 packaged in plastic clam shell with scale label applied
Dairy·287 affected·Jun 24, 2020
CriticalFDA
Beyond Better Foods Llc
Enlightened Dairy-Free Chocolate Peanut Butter Frozen Dessert, one Pint (473 ml). Case GTIN: 1-08-52109-33106-9. Item UPC:8-52109-33150...
Dairy·2,990 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Banana Nut Bread Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net w...
Bakery & Grains·333,420 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Black Cherry Chocolate Creme Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count ...
Snacks & Candy·121,190 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Cookie Dough Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. r...
Bakery & Grains·63,020 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Cashew Caramel with Coconut Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count b...
Snacks & Candy·33,930 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Toffee Almond Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ...
Snacks & Candy·169,670 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
S'Mores Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges...
Snacks & Candy·58,170 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Peanut Butter Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ...
Dairy·242,400 affected·Jun 24, 2020
CriticalFDA
Medichem S.a.
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra,...
Drugs·117,800 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to hel...
Medical Devices·12 affected·Jun 24, 2020
RecallFDA
Dna Genotek Inc.
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the ...
Diagnostic Devices·74 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
SUTUREFIX ULTRA Suture, Product number 72203855
Medical Devices·868 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff re...
Surgical Devices·137 affected·Jun 24, 2020
High RiskFDA
Arthrex, Inc.
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone...
Medical Devices·28 affected·Jun 24, 2020
High RiskFDA
Power Selles Imports Dba Culinary Collective
Blanxart 85% Nicaragua Organic Dark Chocolate Bar, packaged in paper packaging with internal foil wrapper. Net weight 4.4 oz (125 g). UPC...
Dairy·72 affected·Jun 23, 2020
CriticalFDA
Itech 361 Llc
All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya,...
Drugs·18,760 affected·Jun 23, 2020
RecallFDA
Biogen Ma Inc.
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 021...
Oral Drugs·3,922 affected·Jun 23, 2020
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 app...
Drugs·2,800,800 affected·Jun 23, 2020
Medium RiskFDA
Vistapharm, Inc.
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-...
Oral Drugs·380,700 affected·Jun 23, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Appl...
Drugs·12,500 affected·Jun 23, 2020
CriticalFDA
Carefusion 213, Llc
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Pa...
Drugs·4,272,300 affected·Jun 23, 2020
RecallFDA
Vistapharm, Inc.
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Man...
Oral Drugs·14,760 affected·Jun 23, 2020