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High RiskFDA
Restor3d Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Surgical Devices·9 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ Sys...
Cardiac Devices·645 affected·Mar 30, 2022
CriticalFDA
Giant Eagle, Inc.
Giant Eagle, Happy Face Cookie 4 Pack 25051900000, 11 oz, Clam Shell
Bakery & Grains·41 affected·Mar 29, 2022
CriticalFDA
Pink Toyz
Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311...
Oral Drugs·120 affected·Mar 29, 2022
RecallFDA
Aptapharma Inc.
Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 6...
Drugs·40,000 affected·Mar 29, 2022
CriticalFDA
Teva Pharmaceuticals Usa Inc
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, In...
Injectable Drugs·1,565 affected·Mar 29, 2022
CriticalFDA
Best Brands Consumer Products, Inc.
Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company...
Drugs·44,640 affected·Mar 29, 2022
CriticalFDA
Best Brands Consumer Products, Inc.
The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Com...
Drugs·346,320 affected·Mar 29, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 Systems and VITEK 2 with MYLA.
Medical Devices·21,757 affected·Mar 29, 2022
High RiskFDA
Philips North America Llc
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images...
Medical Devices·330 affected·Mar 29, 2022
CriticalFDA
Groundwork Coffee Llc
groundwork MIND-FULL Bar. Ingredients: Gluten-free oats, Flax seed, Chocolate chips, Brown sugar, Chia seeds, peanut butter, salt, cinna...
Dairy·0 affected·Mar 28, 2022
High RiskFDA
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bo...
Oral Drugs·791 affected·Mar 28, 2022
High RiskFDA
Stryker Gmbh
Smart Toe II Intramedullary Arthrodesis Implant
Medical Implants·246 affected·Mar 28, 2022
High RiskFDA
Caire, Inc.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Respiratory Devices·2 affected·Mar 25, 2022
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa li...
Diagnostic Devices·199 affected·Mar 25, 2022
High RiskFDA
Arthrex, Inc.
K-Wire, 1.35 mm x 170 mm
Medical Devices·300 affected·Mar 25, 2022
CriticalFDA
Medtronic Formerly Covidien
Puritan Bennett 980 Series Ventilator
Respiratory Devices·18,508 affected·Mar 25, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Diagnostic Devices·1,575 affected·Mar 25, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Diagnostic Devices·2,502 affected·Mar 25, 2022
RecallFDA
Randox Laboratories Ltd.
CK MB Calibrator, Catalogue Number CK2393
Medical Devices·1,392 affected·Mar 25, 2022
RecallUSDA
Taylor Farms New England Inc.
FSIS Issues Public Health Alert for Ready-to-Eat Chicken Meal Kits Due to Misbranding and Undeclared Allergens
Pork·0 affected·Mar 25, 2022
RecallCPSC
Online At Tonies.com From November 2021 Through December 2021 For Between $15 And $20.
Boxine U.S. Recalls tonies Blocks Due to Magnet Ingestion Hazard; Sold Exclusively at tonies.com (Recall Alert)
Consumer Products·4,200 affected·Mar 24, 2022
RecallCPSC
Online At Www.commencalusa.com From December 2014 Through March 2021 For Between $230 And $320.
Commencal Recalls Ramones 14-Inch Kids Bicycles Due to Crash Hazard (Recall Alert)
Bicycles & Wheeled Sports·925 affected·Mar 24, 2022
RecallCPSC
Awl Distribution, Bv Powersports, And Other Authorized Dealerships Nationwide From May 2020 Through September 2020 For Between $550 And $670.
EGL Motor Recalls EGL and ACE-branded Youth All-Terrain Vehicles (ATVs) Due to Violations of Federal ATV Safety Standard; Risk of Serious Injury or Death
Vehicles / Atvs·500 affected·Mar 24, 2022
RecallCPSC
Walmart Stores Nationwide And Online At Walmart.com From July 2020 Through January 2022 For About $25.
Sakar International Recalls Dimensions Bluetooth Speaker Multi-Purpose Helmets Due to Risk of Head Injury; Sold Exclusively at Walmart
Sports & Recreation·89,000 affected·Mar 24, 2022
RecallCPSC
Best Buy And Other Retailers Nationwide And Online At Segway.com And Amazon.com From December 2020 Through May 2021 For Between $30 And $50.
Segway Recalls Ninebot Children's Bicycle Helmets Due to Risk of Head Injury
Children's Products·960 affected·Mar 24, 2022
High RiskFDA
The Procter & Gamble Company
Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case
Food·23,928 affected·Mar 24, 2022
CriticalFDA
Plastikon Healthcare Llc
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, F...
Drugs·23,300 affected·Mar 24, 2022
CriticalFDA
Plastikon Healthcare Llc
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institution...
Drugs·14,100 affected·Mar 24, 2022
High RiskFDA
Plastikon Healthcare Llc
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distr...
Oral Drugs·121,800 affected·Mar 24, 2022
High RiskFDA
Preferred Pharmaceuticals, Inc.
Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: ...
Topical Drugs·41 affected·Mar 24, 2022
High RiskFDA
Plastikon Healthcare Llc
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, F...
Drugs·106,400 affected·Mar 24, 2022
High RiskFDA
Plastikon Healthcare Llc
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institution...
Drugs·5,400 affected·Mar 24, 2022
High RiskFDA
Preferred Pharmaceuticals, Inc.
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceut...
Topical Drugs·528 affected·Mar 24, 2022
High RiskFDA
Microbiologics Inc
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Medical Devices·1 affected·Mar 24, 2022
High RiskFDA
Abbott
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Surgical Devices·588 affected·Mar 24, 2022
High RiskFDA
Abbott
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Surgical Devices·2,134 affected·Mar 24, 2022
High RiskFDA
Ethicon, Inc.
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code...
Medical Devices·2,808 affected·Mar 24, 2022
High RiskFDA
Suntree Snack Foods, Llc
Good & Gather Dried Sweetened Strawberries. Net Wt 4 oz (113g). UPC 085239-182840 No Sulfites Added. No Artificial Flavors. No Synth...
Produce·3,200 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Lemon Macaron, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Food·41 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Macaron Variety A, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Food·56 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Passion Fruit Mango Macaron, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Produce·27 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Raspberry Macaron, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Produce·54 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Macaron Variety B, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Food·63 affected·Mar 23, 2022
High RiskFDA
Bread Alone, Inc.
Bread Alone Fruit & Nut Sourdough; packaged in 27 ounce plastic bag
Bakery & Grains·838 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Holiday Macaron Variety, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Food·24 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Fall Spice Macaron, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Food·5 affected·Mar 23, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods Door County Cherry Macaron, Case of 100. 537 Atlas Ave, Madison, WI 53714.
Food·63 affected·Mar 23, 2022