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High RiskFDA
Cardinal Health
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Medical Devices·34 affected·Feb 29, 2016
High RiskFDA
Karl Storz Endovision, Inc.
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Numb...
Medical Devices·16,908 affected·Feb 29, 2016
High RiskFDA
Rich Products Corp
New York Style Chocolate Iced ¿clairs under the following labels: 1) Richs New York Style Chocolate Iced ¿clairs, NET WT 8 oz (226g) (UP...
Snacks & Candy·53 affected·Feb 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagno...
Diagnostic Devices·726 affected·Feb 26, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidime...
Cardiac Devices·3,204 affected·Feb 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiop...
Medical Devices·3,090 affected·Feb 26, 2016
High RiskFDA
Northwest Specialty, Inc.
Dried lactose powder, product sold under brand Wine-King Beer-King, packaged in three consumer-sized plastic bags of 4 oz., 1 Lb. and 5 ...
Food·55 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clere...
Medical Devices·19,250 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3...
Medical Devices·50 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 st...
Medical Devices·7,500 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile device...
Medical Devices·400 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3...
Medical Devices·350 affected·Feb 25, 2016
High RiskFDA
Ossur H / F
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, po...
Medical Devices·7,623 affected·Feb 24, 2016
High RiskFDA
Purewick Corporation
PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the ...
Surgical Devices·176,863 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to l...
Medical Devices·9 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO fro...
Medical Devices·401 affected·Feb 24, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of med...
Diagnostic Devices·6 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability...
Medical Devices·24 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligame...
Medical Devices·1,030 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
Medical Devices·456 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
Medical Devices·2 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament inj...
Medical Devices·15 affected·Feb 24, 2016
High RiskFDA
Amd Ritmed
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 b...
Medical Devices·126 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injur...
Medical Devices·7 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Medical Devices·15,825 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobiliza...
Medical Devices·2,010 affected·Feb 24, 2016
High RiskFDA
Ab Sciex
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 50...
Diagnostic Devices·279 affected·Feb 24, 2016
High RiskFDA
True Nature Llc
Garlic Hummus - 9 oz container
Food·414 affected·Feb 23, 2016
High RiskFDA
True Nature Llc
Original Hummus 9oz container
Food·464 affected·Feb 23, 2016
High RiskFDA
True Nature Llc
Arugula Hazelnut Pesto 7oz container
Food·384 affected·Feb 23, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Respiratory Devices·72,000 affected·Feb 23, 2016
High RiskFDA
Mako Surgical Corporation
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting aceta...
Medical Implants·96 affected·Feb 23, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analy...
Medical Devices·35 affected·Feb 23, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
QUADROX-i oxygenators Custom tubing packs for the oxygenator
Respiratory Devices·72,000 affected·Feb 23, 2016
High RiskFDA
Medtronic Inc.
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Cardiac Devices·189,009 affected·Feb 23, 2016
High RiskFDA
Synthes (usa) Products Llc
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating Sy...
Medical Devices·500 affected·Feb 23, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Respiratory Devices·72,000 affected·Feb 23, 2016
High RiskFDA
Naturebox, Inc.
NatureBox Cinnamon Yogurt Mini Grahams, 6 oz. (170g) customer stand up pouches. UPC 8 58590 00528 4 Ingredients: Graham Crackers (u...
Dairy·7,419 affected·Feb 22, 2016
High RiskFDA
Pentax Medical Company
Video Duodenoscope
Medical Devices·423 affected·Feb 22, 2016
High RiskFDA
Medtronic Navigation, Inc.
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Ki...
Surgical Devices·4 affected·Feb 22, 2016
High RiskFDA
Villa Radiology Systems Llc
Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray sy...
Medical Devices·66 affected·Feb 19, 2016
High RiskFDA
Villa Radiology Systems Llc
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Medical Devices·66 affected·Feb 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha, mobile X-ray system
Medical Devices·89 affected·Feb 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and...
Cardiac Devices·1,757 affected·Feb 19, 2016
High RiskFDA
Villa Radiology Systems Llc
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Medical Devices·66 affected·Feb 19, 2016
High RiskFDA
Medtronic Minimed Inc.
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of contin...
Diabetes Devices·20 affected·Feb 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neu...
Cardiac Devices·1,757 affected·Feb 19, 2016
High RiskFDA
Villa Radiology Systems Llc
Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Medical Devices·66 affected·Feb 19, 2016