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High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·54 affected·Nov 27, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for...
Diagnostic Devices·0 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·8 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervi...
Medical Devices·9 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ve...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
United Orthopedic Corporation
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indic...
Surgical Devices·69 affected·Nov 24, 2017
High RiskFDA
United Orthopedic Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthr...
Surgical Devices·14 affected·Nov 24, 2017
High RiskFDA
Colorado Nut Co
Frontier Trail Mix (4 oz. bag), UPC 018142352987. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Food·46,400 affected·Nov 22, 2017
High RiskFDA
Colorado Nut Co
Peanut Delight (8 oz. bag), UPC 018142352512. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Food·1,739 affected·Nov 22, 2017
High RiskFDA
Colorado Nut Co
Honey Nutty Granola (8 oz. bag), UPC 018142352147. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Bakery & Grains·223 affected·Nov 22, 2017
High RiskFDA
Colorado Nut Co
Oat Bran Nutty Crunch (8 oz. bag), UPC 018142352130. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Food·83 affected·Nov 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Medical Devices·58 affected·Nov 22, 2017
High RiskFDA
Medical Components, Inc Dba Medcomp
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Surgical Devices·24 affected·Nov 22, 2017
High RiskFDA
Apollo Endosurgery Inc
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that a...
Medical Implants·54 affected·Nov 22, 2017
High RiskFDA
Leclerc Foods Usa
Fit & Active Chocolatey Chip Protein Meal Bars; UPC: 41498 18695; Lot Code: Q209MY; Expiration date: May 24, 2018
Snacks & Candy·2,701 affected·Nov 21, 2017
High RiskFDA
Covidien Llc
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Vent...
Respiratory Devices·15,885 affected·Nov 21, 2017
High RiskFDA
Medica Corporation
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use...
Diagnostic Devices·392 affected·Nov 21, 2017
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Diagnostic Devices·10 affected·Nov 21, 2017
High RiskFDA
Santa Joy Ornament & Giftware Co
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various c...
Medical Devices·433,128 affected·Nov 21, 2017
High RiskFDA
Oculus Optikgeraete Gmbh
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikge...
Medical Implants·83 affected·Nov 21, 2017
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glen...
Topical Drugs·5,136 affected·Nov 20, 2017
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) co...
Oral Drugs·19,812 affected·Nov 20, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured...
Oral Drugs·5,374 affected·Nov 20, 2017
High RiskFDA
Raysearch Laboratories Ab
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (Ray...
Medical Devices·744 affected·Nov 20, 2017
High RiskFDA
Phadia Ab
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and El...
Diagnostic Devices·2,307 affected·Nov 20, 2017
High RiskFDA
Zimmer Dental Inc
Tapered Screw-Vent MTX Model TSVTB11
Medical Devices·500 affected·Nov 20, 2017
High RiskFDA
Invivo Corporation
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of ...
Cardiac Devices·1,040 affected·Nov 20, 2017
High RiskFDA
Omnilife Science Inc.
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revisio...
Medical Implants·32 affected·Nov 20, 2017
High RiskFDA
Elekta Limited
Integrity R1.2
Medical Devices·539 affected·Nov 20, 2017
High RiskFDA
Elekta Limited
Agility with Integrity R3.2
Medical Devices·539 affected·Nov 20, 2017
High RiskFDA
Virginia Diner Inc
Plow & Hearth Chocolate Covered Cashews
Snacks & Candy·60 affected·Nov 17, 2017
High RiskFDA
Plow And Hearth
89291 Cashew Tower (Plow and Hearth Chocolate Covered Cashews). Net weight: 10 ounces . The product is package as a Individual can is se...
Snacks & Candy·1,332 affected·Nov 17, 2017
High RiskFDA
Lupin Limited
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 2120...
Oral Drugs·0 affected·Nov 17, 2017
High RiskFDA
Stryker Corporation
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Medical Devices·60,753 affected·Nov 17, 2017
High RiskFDA
Philips Electronics North America Corporation
IntelliVue X3 Patient Monitor.
Medical Devices·975 affected·Nov 17, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infus...
Medical Devices·73,611 affected·Nov 17, 2017
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate ...
Medical Devices·8 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated syste...
Medical Devices·87 affected·Nov 17, 2017
High RiskFDA
Stryker Corporation
STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600);...
Medical Devices·60,753 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system ...
Medical Devices·29 affected·Nov 17, 2017
High RiskFDA
Z-medica, Llc
QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may...
Surgical Devices·4,890 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system...
Medical Devices·118 affected·Nov 17, 2017
High RiskFDA
Sichuan Youjia Foodstuffs Co., Ltd
BAMBOO SHOOTS SAUCE (Marinated Bamboo) packaged in a glass jar, net wt. 220g. UPC: 6 930841 008230
Food·40 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Dark Chocolate Almonds, Natural Dark Chocolate Almonds, 12/7 oz., and 12/12 oz.
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Natural Dark Chocolate Cranberries
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Dark Chocolate Coffee Beans, Natural Dark Chocolate Coffee Beans
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Dark Chocolate Almond Bark, 12/8oz.
Snacks & Candy·0 affected·Nov 16, 2017