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High RiskFDA
Philips North America Llc
Ingenia Elition X, Magnetic Resonance System.
Medical Devices·448 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Enterprise 1.5T, Magnetic Resonance System.
Medical Devices·33 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
MR 7700, Magnetic Resonance System.
Medical Devices·26 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
GYROSCAN T5, Magnetic Resonance System.
Medical Devices·7 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Medical Devices·24 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 3.0TX for PET, Magnetic Resonance System.
Medical Devices·1 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera CV, Magnetic Resonance System.
Medical Devices·8 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T Conversion, Magnetic Resonance System.
Medical Devices·115 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T R11, Magnetic Resonance System.
Medical Devices·25 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T Initial, Magnetic Resonance System.
Medical Devices·69 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Medical Devices·19 affected·Mar 12, 2024
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
CriticalFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
Sunflour Bakery Banana Nut Sweet Bread, 16 oz, clear poly bag
Bakery & Grains·316 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
CriticalFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
German Home Bakery Hazelnut Coffee Cake, 16 oz, clear poly bag
Bakery & Grains·156 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovascul...
Medical Devices·117 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the ne...
Surgical Devices·200 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into ...
Medical Devices·750 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neu...
Medical Devices·10 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasc...
Medical Devices·19 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
CriticalFDA
John B. Sanfilippo & Son Inc.
Great Value Honey Roasted Cashews, 8.25oz. plastic can, UPC 0 78742 13334 8
Food·17,184 affected·Mar 7, 2024
CriticalFDA
Stonewall Kitchen, Llc
Stonewall Kitchen Cinnamon Sugar Doughnut Mix; Gluten Free; Home-Baked & Gluten Free; Net Wt. 18oz (510g); UPC: 1138131332
Food·2,405 affected·Mar 7, 2024
CriticalFDA
Wesco Central Commissary
Wesco mint no-bake cookie bites 9oz cup UPC 750308040474
Bakery & Grains·1,248 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
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Medical Devices·17 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
CriticalFDA
Outset Medical, Inc.
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Medical Devices·919 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