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High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Frito-lay, Inc.
Lay's French Onion dip 15 oz. UPC 2840007094 packaged in clear glass jars
Produce·3,528,552 affected·May 4, 2020
High RiskFDA
Frito-lay, Inc.
Ruffles Ranch flavoured dip 425 g (15 oz). UPC 6041007299 packaged in clear glass jars
Food·241,620 affected·May 4, 2020
High RiskFDA
Essential Baking Company, The
The product is twisted bread and packaged in a flexible plastic bag with a yellow Kwik-Lok seal. The label is read in parts: "***ORG...
Dairy·84 affected·May 4, 2020
High RiskFDA
Frito-lay, Inc.
Ruffles Onion flavoured dip 425 g (15 oz). UPC 6041007298 packaged in clear glass jars
Produce·241,620 affected·May 4, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeuti...
Surgical Devices·119,723 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quan...
Diabetes Devices·5 affected·May 4, 2020
High RiskFDA
Umano Medical, Inc.
AC Powered hospital adjustable bed.
Medical Devices·3,259 affected·May 4, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the ce...
Medical Devices·119,723 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative ...
Medical Devices·1,488 affected·May 4, 2020
High RiskFDA
Resource Optimization & Innovation Llc
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing o...
Medical Devices·12,640 affected·May 4, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous...
Medical Devices·119,723 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement ...
Diabetes Devices·26 affected·May 4, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of ...
Surgical Devices·119,723 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative dete...
Medical Devices·8,261 affected·May 4, 2020
High RiskFDA
Biomet
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Surgical Devices·705 affected·May 1, 2020
High RiskFDA
Biomet
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Surgical Devices·136 affected·May 1, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: ...
Surgical Devices·480 affected·Apr 30, 2020
High RiskFDA
Elekta, Inc.
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments an...
Medical Devices·32 affected·Apr 30, 2020
High RiskFDA
Normand-info S.a.s.u.
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for...
Medical Devices·663 affected·Apr 30, 2020
High RiskFDA
Cook Inc.
Pressure Monitoring Set, C-PMS, G02838
Medical Devices·6,792 affected·Apr 30, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 1084828...
Diagnostic Devices·15 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter P...
Surgical Devices·46,828 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Lu...
Surgical Devices·3,470 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with L...
Surgical Devices·23,587 affected·Apr 30, 2020
High RiskFDA
Diasol, Inc
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Medical Devices·212 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 ...
Surgical Devices·0 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: f...
Surgical Devices·0 affected·Apr 30, 2020
High RiskFDA
Medtronic Inc.
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monit...
Diabetes Devices·391 affected·Apr 30, 2020
High RiskFDA
Hill-rom, Inc.
Centrella Smart+ Bed, Catalog Number P7900
Medical Devices·4,381 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladde...
Surgical Devices·3,012 affected·Apr 30, 2020
High RiskFDA
Ricker Hill Farms, Inc.
RICKER HILL ORCHARDS APPLE CIDER McIntosh Blend, 1 GAL (128 FL OZ) and 1/2 GAL (64 FL OZ); UPC: 0 74613 80009 8; MADE IN MAINE; KEEP REFR...
Produce·455 affected·Apr 29, 2020
High RiskFDA
Thermo Fisher Scientific (monterrey)
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used fo...
Medical Devices·78,600 affected·Apr 29, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872
Supplements·29,844 affected·Apr 28, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Respiratory Devices·5,883 affected·Apr 28, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Respiratory Devices·5,883 affected·Apr 28, 2020
High RiskFDA
Defibtech, Llc
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Defibtech, Llc
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A101...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination ...
Cardiac Devices·260 affected·Apr 27, 2020
High RiskFDA
Argon Medical Devices, Inc
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introduc...
Surgical Devices·15,795 affected·Apr 26, 2020
High RiskFDA
Middle East Bakery, Inc.
Joseph's Gluten Free Original Wrap, 4 wraps, Net. Wt. 5.6 oz., UPC Code: 074117-003612
Food·7,133 affected·Apr 25, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Medical Devices·240 affected·Apr 24, 2020