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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
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Medical Devices·3,948 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
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Medical Devices·719 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
CriticalFDA
Olympus Corporation Of The Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model...
Medical Devices·15,942 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
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Medical Devices·13,950 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Medical Devices·32,211 affected·Oct 12, 2023
CriticalFDA
Unomedical A/s
VariSoft infusion set, Model Number 1002828
Medical Devices·1,679 affected·Oct 11, 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
CriticalFDA
Greenhead Lobster Products Llc
Frozen and fresh RTE Lobster meat (1 lb. packages to 12 lb. case) 1. Greenhead Lobster HPP Fresh Cooked Claw and Knuckle Meat GHL-CKF - ...
Meat & Poultry·222,821 affected·Oct 9, 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
High RiskFDA
Philips North America Llc
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and t...
Medical Devices·11 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 28 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 Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 12 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 Llc
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Medical Devices·56 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Philips Ultrasound, Inc.
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Diagnostic Devices·7 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
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
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement ...
Medical Devices·0 affected·Oct 9, 2023