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High RiskFDA
Masimo Corporation
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Medical Devices·138,926 affected·Apr 21, 2023
High RiskFDA
Masimo Corporation
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Medical Devices·443,799 affected·Apr 21, 2023
High RiskFDA
C.r. Bard Inc
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) RE...
Surgical Devices·308,520 affected·Apr 20, 2023
High RiskFDA
C.r. Bard Inc
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f...
Surgical Devices·9,894,922 affected·Apr 20, 2023
High RiskFDA
Litehouse Inc.
Simple Truth Plant Based Ranch Dressing 12floz bottle UPC 01110609779. 6 retail bottle per wholesale case.
Food·495 affected·Apr 19, 2023
High RiskFDA
Sun Pharmaceutical Industries Ltd.
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only,...
Injectable Drugs·24,194 affected·Apr 19, 2023
High RiskFDA
Seatex Llc
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 1259...
Topical Drugs·2,880 affected·Apr 19, 2023
High RiskFDA
Philips North America
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Medical Devices·591 affected·Apr 19, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie M&M cookie, plastic wrapped; Country Cookie Mini Cups of Cookies M&M Cookie
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Sugar Frosted Cookie, plastic wrapped
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Banana Cake, plastic clamshell
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Chocolate Chocolate Chip cookie, plastic wrapped
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Cranberry Oatmeal White Chocolate cookie, plastic wrapped
Bakery & Grains·0 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Sprinkled Sugar Cookie, plastic wrapped
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Peanut Butter Cookie, plastic wrapped
Dairy·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Oatmeal Chocolate Chip, plastic wrapped
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Chocolate Brownie, plastic clamshell
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Chocolate Chip Cookie, plastic wrapped; Mini Cups of Cookies Chocolate Chip Cookie
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Pumpkin Bar, plastic clamshell
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Cookies and Cream cookie, plastic wrapped
Dairy·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Sugar Cookie, plastic wrapped
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Country Cookie Llc.
Country Cookie Snickerdoodle Cookie, plastic wrapped
Bakery & Grains·1,104 affected·Apr 18, 2023
High RiskFDA
Deroyal Industries Inc
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.0...
Surgical Devices·23 affected·Apr 17, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mm...
Diagnostic Devices·23,751 affected·Apr 17, 2023
High RiskFDA
Deroyal Industries Inc
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, S...
Surgical Devices·1,391 affected·Apr 17, 2023
High RiskFDA
Washington Crab & Seafood Company, Inc.
BLUE CRAB DIP 8 oz Ingredients: Blue Crabmeat, cream cheese, vidalia onion, salt, paprika, and spice WASHINGTON CRAB Carolina Seafood
Dairy·3,469 affected·Apr 14, 2023
High RiskFDA
Washington Crab & Seafood Company, Inc.
COCKTAIL SAUCE Ingredients: Ketchup horseradish, vinegar Worcestershire sauce garlic salt Net Wt 8 oz WASHINGTON CRAB Carolina seafood
Seafood·52 affected·Apr 14, 2023
High RiskFDA
Shearer's Foods, Llc
Great Value Kettle Cooked Lightly Salted Potato Chips packaged in 8oz individual plastic bags - 8 bags per case
Snacks & Candy·46 affected·Apr 14, 2023
High RiskFDA
Stryker Sustainability Solutions
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Medical Devices·50 affected·Apr 14, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Version...
Diagnostic Devices·132 affected·Apr 14, 2023
High RiskFDA
Borris Brothers
Smoked Mahi Dip, Net Wt. 8oz and 48oz
Food·95 affected·Apr 13, 2023
High RiskFDA
Creekside Mallow Llc
Creekside Mallow Chocolate Chip Mint Marshmallows, packed in a Stand Up Flexible Pouch (Bag), Net wt. 3.9oz. UPC 7 09951 63271 0. Manufac...
Dairy·2,800 affected·Apr 13, 2023
High RiskFDA
Borris Brothers
Smoked Wahoo Dip, Net Wt. 8oz
Food·112 affected·Apr 13, 2023
High RiskFDA
Borris Brothers
Smoked Swordfish Dip, Net Wt. 8oz
Seafood·55 affected·Apr 13, 2023
High RiskFDA
Dole Fresh Vegetables Inc
Dole Chopped Kit Teriyaki Pineapple iceberg lettuce green leaf lettuce red cabbage sliced almonds teriyaki pineapple dressing crunchy noo...
Beverages·181 affected·Apr 13, 2023
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
Injectable Drugs·45 affected·Apr 13, 2023
High RiskFDA
Howmedica Osteonics Corp.
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Medical Devices·24 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative imm...
Medical Devices·540 affected·Apr 13, 2023
High RiskFDA
Howmedica Osteonics Corp.
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Medical Devices·24 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliz...
Medical Devices·2,372 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobili...
Medical Devices·3,328 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative im...
Medical Devices·805 affected·Apr 13, 2023
High RiskFDA
Philips Headquarters Cambridge
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Medical Devices·7 affected·Apr 12, 2023
High RiskFDA
Philips Headquarters Cambridge
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Medical Devices·22 affected·Apr 12, 2023
High RiskFDA
Philips Headquarters Cambridge
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Medical Devices·5 affected·Apr 12, 2023
High RiskFDA
Sanofi-aventis U.s. Llc
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A S...
Injectable Drugs·51,325 affected·Apr 11, 2023
High RiskFDA
Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Medical Devices·4,120 affected·Apr 11, 2023
High RiskFDA
Dibe Llc
TETAS Mireya, SABOR Nutella
Food·250 affected·Apr 10, 2023