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High RiskFDA
Canadian Art Prints
Tranquility & Teachings William Monague plate set, brand Indigenous Collection by CAP. Each box consists of two plates, each plate is 7.5...
Food·83 affected·Mar 11, 2024
High RiskFDA
Advanced Instruments, Llc
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of se...
Medical Devices·58 affected·Mar 11, 2024
High RiskFDA
Conformis, Inc.
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Medical Devices·3 affected·Mar 11, 2024
High RiskFDA
Baxter Healthcare Corporation
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Medical Devices·80 affected·Mar 11, 2024
High RiskFDA
Pepsico Inc
Schweppes ZERO SUGAR GINGER ALE CAFFIENE FREE 7.5 FL OZ (221 mL) PRODUCED UNDER THE AUTHORITY OF DR. PEPPER/SEVEN UP, INC., 5301 LEGACY D...
Produce·233 affected·Mar 9, 2024
High RiskFDA
Noah Medical
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronc...
Diagnostic Devices·17 affected·Mar 9, 2024
High RiskFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
German Home Bakery Poppy Coffee Cake, 16 oz, clear poly bag
Bakery & Grains·197 affected·Mar 8, 2024
High RiskFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
German Home Bakery Raspberry Coffee Cake, 16 oz, clear poly bag
Bakery & Grains·70 affected·Mar 8, 2024
High RiskFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
Marzipan/Almond Coffee Cake, 16 oz, in clear poly bags
Bakery & Grains·181 affected·Mar 8, 2024
High RiskFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
German Home Bakery Cherry Coffee Cake, 16 oz, clear poly bag
Bakery & Grains·92 affected·Mar 8, 2024
High RiskFDA
Raja Foods Llc
SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC 0-51179-34280-4, 20 retail units per wholesale case
Food·200 affected·Mar 7, 2024
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 T...
Oral Drugs·92,676 affected·Mar 7, 2024
High RiskFDA
Innomed, Inc.
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Medical Devices·41 affected·Mar 7, 2024
High RiskFDA
Olympus Corporation Of The Americas
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties...
Surgical Devices·150 affected·Mar 7, 2024
High RiskFDA
Otis Mcallister
Product LAbeled in part: "Emerald River Premium Thai Jasmine Rice ... Net Wt 50 lb (22.7 kg) ... UPC 0 28571 00474 6"
Food·2,700 affected·Mar 6, 2024
High RiskFDA
Colonna Brothers Inc.
Supreme Tradition brand and Marcum brand ground cinnamon. Packaged in 1.5 oz and 2.25 oz clear plastics jars
Food·0 affected·Mar 6, 2024
High RiskFDA
B. Braun Medical Inc
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18...
Injectable Drugs·22,752 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Ite...
Medical Devices·39 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-0...
Medical Devices·985 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Medical Devices·447 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoul...
Medical Devices·591 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Medical Devices·2,806 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, ...
Medical Devices·12,643 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, ...
Medical Devices·4,007 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Nu...
Medical Devices·6,840 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium...
Medical Devices·6,678 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13,...
Medical Devices·7,213 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium...
Medical Devices·2,008 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arth...
Medical Devices·11,863 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item...
Medical Devices·35 affected·Mar 6, 2024
High RiskFDA
Microbiologics Inc
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Medical Devices·19 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, ...
Medical Devices·3,436 affected·Mar 6, 2024
High RiskFDA
Wright Medical Technology, Inc.
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Medical Devices·47 affected·Mar 6, 2024
High RiskFDA
Thea Pharma, Inc.
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Ophthalmic Drugs·5,476 affected·Mar 5, 2024
High RiskFDA
Unomedical A/s
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Medical Devices·10,770 affected·Mar 5, 2024
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of...
Medical Devices·232 affected·Mar 5, 2024
High RiskFDA
Boston Scientific Corporation
OptiCross Coronary Imaging Catheter, REF H749518080120
Surgical Devices·239 affected·Mar 5, 2024
High RiskFDA
Randox Laboratories Ltd.
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clin...
Medical Devices·80,366 affected·Mar 5, 2024
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative de...
Diagnostic Devices·17 affected·Mar 5, 2024
High RiskFDA
Quidel Corporation
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Medical Devices·31,140 affected·Mar 5, 2024
High RiskFDA
Bob Evans Farms (bef)
Bob Evan's Original Mash Potato 2lbs (32 oz) packaged in black plastic tray with clear film and corrugate sleeve overwrap. 6 units per case
Food·410 affected·Mar 4, 2024
High RiskFDA
El Chilar-hf, Llc
El Chilar, Canela Molida, Ground Cinnamon NET WT. 1.25 Oz (35g) , BOPP Bag, 12 units per cases
Food·272 affected·Mar 4, 2024
High RiskFDA
La Fiesta Food Products
La Fiesta, Canela Molida, Cinnamon Ground, 0.87oz (24.8g), UPC #032327000449, packed in cello bags
Food·16,044 affected·Mar 4, 2024
High RiskFDA
Albertsons Companies Llc
Signature Select, Athens, and Cal Pia brand Bread Butter White Bread 22 oz. loaf
Dairy·13,550 affected·Mar 4, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured...
Oral Drugs·7,488 affected·Mar 4, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufacture...
Oral Drugs·47,520 affected·Mar 4, 2024
High RiskFDA
Abbott Gmbh
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Diagnostic Devices·7,219 affected·Mar 4, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Medical Devices·8 affected·Mar 4, 2024