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High RiskFDA
Keystone Laboratories Inc
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEY...
Drugs·7 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Medical Devices·1,627 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physio...
Cardiac Devices·24 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software.
Medical Devices·217 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and rec...
Cardiac Devices·2 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures...
Cardiac Devices·219 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Medical Devices·333 affected·Apr 4, 2016
High RiskFDA
Synthes (usa) Products Llc
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Medical Implants·15 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·17 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·29 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Medical Devices·78 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare.
Medical Devices·248 affected·Apr 4, 2016
High RiskFDA
Flying Food Group Llc
Dunkin Donuts Brand Italian Sub, Net Wt 7.7 oz packaged in Bag, Clear View
Food·28 affected·Apr 2, 2016
High RiskFDA
Flying Food Group Llc
Shaw's Brand Market Fresh Eggplant & Cheese Wrap, 10.0 oz packaged in plastic inside a paper open box
Dairy·63 affected·Apr 2, 2016
High RiskFDA
Flying Food Group Llc
Shaw's Brand Market Fresh Turkey & Roasted Red Peppers on Wheat, 5.4 oz. packaged in a wedge container
Meat & Poultry·41 affected·Apr 2, 2016
High RiskFDA
Flying Food Group Llc
Dietz & Watson Brand Roasted Veggie White Tortilla Wrap - 9.68 oz wrapped in plastic in a open paper box
Food·11 affected·Apr 2, 2016
High RiskFDA
Flying Food Group Llc
Shaw's Brand Market Fresh Shaw Market Fresh Italian Sub, 8.3 oz. wrapped in plastic in open paper box container
Food·109 affected·Apr 2, 2016
High RiskFDA
Flying Food Group Llc
Dietz & Watson Brand Italian Sub 7.3 oz bag
Food·33 affected·Apr 2, 2016
High RiskFDA
Roland Foods, Llc.
Roland (R) Fire Roasted Red Pepper Strips, NET WT. 5 LB. 8 OZ. (2.5 kg), UPC 10041224456287 (carton) and 04122456280 (can), PRODUCT OF PE...
Food·3,592 affected·Apr 1, 2016
High RiskFDA
Diamond Foods, Inc.
Emerald 100 Calorie Packs of Cashew Halves & Pieces, roasted and salted. 7 pack/ 0.62 oz. each (17.5 g). Ingredients: Cashews, Vegeta...
Produce·10,623 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Arthroscope.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray...
Medical Devices·94 affected·Apr 1, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Medical Devices·2,062 affected·Apr 1, 2016
High RiskFDA
Applied Medical Resources Corp
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures....
Surgical Devices·559,274 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Reamer.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography...
Medical Devices·19 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray s...
Medical Devices·18 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
Medical Implants·0 affected·Apr 1, 2016
High RiskFDA
The Coca-cola Company
Dr. Pepper Cherry, 12oz (12 pack cans), Manufactured under the authority of Doctor Pepper Company, 5301 Legacy Drive, Plano, TX.
Food·1,020 affected·Mar 31, 2016
High RiskFDA
Invisiblu International Llc
LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
Oral Drugs·3,319 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·182 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·5 affected·Mar 31, 2016
High RiskFDA
St Jude Medical Inc.
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD ...
Medical Implants·127 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·6 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·449 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·27 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·262 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·15 affected·Mar 31, 2016
High RiskFDA
Hologic, Inc
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Medical Devices·2,580 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·7 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·15 affected·Mar 31, 2016