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High RiskFDA
Integrity Bio-chemicals Llc
Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Bio...
Topical Drugs·1 affected·Oct 18, 2023
High RiskFDA
Auris Health Inc
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Medical Devices·110 affected·Oct 18, 2023
High RiskFDA
Microbiologics Inc
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Medical Devices·13 affected·Oct 18, 2023
High RiskFDA
Auris Health Inc
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Medical Devices·110 affected·Oct 18, 2023
High RiskFDA
Emd Millipore Corporation
Lugol s Iodine Solution 500ML, Part Number 624-71
Medical Devices·5 affected·Oct 17, 2023
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArr...
Medical Devices·32,910 affected·Oct 17, 2023
High RiskFDA
La Michoacana 100% Natural Inc
ICE CREAM BAR, MICHOACANA, es...natural, ROMPOPE, Net. Wt. 6 Fl. Oz., Packaged in a plastic bag. Frozen.
Dairy·170 affected·Oct 16, 2023
High RiskFDA
Aizu Olympus Co., Ltd.
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Medical Devices·24 affected·Oct 16, 2023
High RiskFDA
Aizu Olympus Co., Ltd.
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Medical Devices·24 affected·Oct 16, 2023
High RiskFDA
Aizu Olympus Co., Ltd.
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Medical Devices·24 affected·Oct 16, 2023
High RiskFDA
Lgnds Llc
TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, FRUIT PUNCH, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extrac...
Produce·15,000 affected·Oct 13, 2023
High RiskFDA
Select Custom Solutions, Llc
JayRobb Vanilla Flavored Egg White Protein Powder. Net Weight 24 oz (1.5 lbs) 680g Dietary Supplement. UPC 6 03907-00462 3
Supplements·1,008 affected·Oct 13, 2023
High RiskFDA
Lgnds Llc
TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, Mocha, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extract (30%...
Supplements·15,000 affected·Oct 13, 2023
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made i...
Oral Drugs·1,656 affected·Oct 13, 2023
High RiskFDA
Corin Ltd
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Medical Devices·1 affected·Oct 13, 2023
High RiskFDA
Breas Medical, Inc.
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. ...
Respiratory Devices·215 affected·Oct 13, 2023
High RiskFDA
Ben E Keith Foods - Fort Worth
DRESSING GREEK FETA
Food·1,721 affected·Oct 12, 2023
High RiskFDA
Ben E Keith Foods - Fort Worth
TATER KEG BACON CHEDDAR CHIVE; OKRA CUT HEAVILY BREADED IQF; POTATO TATER TOTS; FRENCH FRIES SC 3/8 IN; JALAPENO STUFFED W/CHDR CHS; CORN...
Bakery & Grains·1,721 affected·Oct 12, 2023
High RiskFDA
Ben E Keith Foods - Fort Worth
BREAD SANDWICH WHITE LOAF, ROLL DINNER HAWAIIAN, BUN HAMBURGER WHITE 4.5 IN FZN
Bakery & Grains·1,721 affected·Oct 12, 2023
High RiskFDA
Ben E Keith Foods - Fort Worth
LEMON CHOICE MINI PK 34-44 CT; STRAWBERRY SLICED 4-1
Produce·1,721 affected·Oct 12, 2023
High RiskFDA
Ben E Keith Foods - Fort Worth
MILK HOMO GALLON
Dairy·1,721 affected·Oct 12, 2023
High RiskFDA
Ben E Keith Foods - Fort Worth
SHRIMP RAW P&D WHITE 16-20 CT
Seafood·1,721 affected·Oct 12, 2023
High RiskFDA
Maquet Medical Systems Usa
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Respiratory Devices·1,022 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medical Devices·173 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Medical Devices·48 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Medical Devices·2,767 affected·Oct 12, 2023
High RiskFDA
Sunmed Holdings, Llc
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: C...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow ...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Ad...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check A...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Becton Dickinson & Company
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resu...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Mc3 Inc
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxi...
Respiratory Devices·299 affected·Oct 11, 2023
High RiskFDA
Becton Dickinson & Company
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PE...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Re...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
The Cookie Factory Llc
Stewarts Chocolate Chip Cookies; 6 oz package; packaged in a flexible plastic clamshell type package
Bakery & Grains·2,700 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Stay Safe Cap
Medical Devices·18,236,160 affected·Oct 10, 2023
High RiskFDA
Beaver Visitec International, Inc.
Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Medical Devices·2,160 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Medical Devices·0 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Medical Devices·216 affected·Oct 10, 2023
High RiskFDA
Betty Lou's Inc
Stabilyze Sugar Stable Dark Chocolate Peanut Butter, 50g (1.76 oz), sold individual package or box. Each package has UPC 0 16073 00213 1...
Dairy·5,197 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Medical Devices·1 affected·Oct 9, 2023