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High RiskFDA
Cook Inc.
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606;...
Medical Devices·12,556 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Medical Devices·470 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Medical Devices·751 affected·Jan 31, 2018
High RiskFDA
3m Company - Health Care Business
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Medical Devices·158,179 affected·Jan 31, 2018
RecallCPSC
Walgreens Stores Nationwide And Online At Www.walgreens.com From March 2017 Through November 2017 For About $7.
Walgreens Pain and Itch Relief Cream Recalled by Natureplex Due to Failure to Meet Child Resistant Closure Requirement
Children's Products·74,000 affected·Jan 30, 2018
High RiskFDA
Sumano's Bakery
Sourdough French: Product number 2044; SKU 61659799; GTIN [00046567600932] ; UPC 831 49000044 20 pieces; Ingredients: Unbleached ...
Bakery & Grains·3,155 affected·Jan 30, 2018
High RiskFDA
Sumano's Bakery
Sourdough Baguette: Product number 2064; SKU 61659798; GTIN [00046567600949]; UPC 831 49000064 20 pieces; Ingredients: Unbleached...
Bakery & Grains·3,155 affected·Jan 30, 2018
High RiskFDA
Millennium Pharmaceuticals Inc.
VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride ...
Injectable Drugs·154,372 affected·Jan 30, 2018
High RiskFDA
Orthofix Srl
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX ...
Surgical Devices·408 affected·Jan 30, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic t...
Diagnostic Devices·6,000 affected·Jan 30, 2018
High RiskFDA
Encore Medical, Lp
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical ...
Medical Implants·387 affected·Jan 30, 2018
High RiskFDA
Kingston Pharma Llc
Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 mL); DIETARY SUPPLEMENT, UPC 050428581186
Produce·13,536 affected·Jan 29, 2018
High RiskFDA
Despana Brand Foods
DON BOCARTE ARTE EN EL PALADAR MIGAS BONITO DEL NORTE PESCA SELECTA DEL CANTABRICO; UPC: 8 43700227144
Food·120 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, IN...
Oral Drugs·34,125 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-12...
Oral Drugs·12,579 affected·Jan 29, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laborato...
Drugs·1,118,046 affected·Jan 29, 2018
RecallFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT,...
Drugs·554 affected·Jan 29, 2018
Medium RiskFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laborato...
Drugs·929,916 affected·Jan 29, 2018
RecallFDA
Mckesson Packaging Services
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a ...
Oral Drugs·24,120 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, IN...
Oral Drugs·28,941 affected·Jan 29, 2018
RecallFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, ...
Drugs·576 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder ...
Medical Devices·92 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoul...
Medical Devices·93 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder ...
Medical Devices·92 affected·Jan 29, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated...
Cardiac Devices·28,094 affected·Jan 29, 2018
RecallFDA
Iq Produce, Llc
Fresh Fragrant Pear; Label - Double Trees Product of China Shenzhen J.F. Fruit Co., LTD
Produce·2,402 affected·Jan 27, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Ma...
Oral Drugs·135,277 affected·Jan 26, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Ma...
Oral Drugs·7,826 affected·Jan 26, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmac...
Oral Drugs·4,006 affected·Jan 26, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmace...
Oral Drugs·160,489 affected·Jan 26, 2018
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other...
Medical Devices·5 affected·Jan 26, 2018
CriticalFDA
Biomerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card ...
Diagnostic Devices·13,961,320 affected·Jan 26, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Diagnostic Devices·42 affected·Jan 26, 2018
High RiskFDA
Raysearch Laboratories Ab
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, ...
Medical Devices·2,484 affected·Jan 26, 2018
High RiskFDA
Stryker Communications
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light Sy...
Surgical Devices·850 affected·Jan 26, 2018
RecallCPSC
Elkay Distributors From May 2017 Through June 2017 For Between $600 And $7,450.
Elkay Recalls Water Coolers and Bottle Filling Stations Due to Shock Hazard
Consumer Products·31,600 affected·Jan 25, 2018
RecallCPSC
Rockler Stores Nationwide, Rockler Catalog And Online At Rockler.com From January 2017 Through October 2017 For Between $300 And $400.
Rockler Recalls Murphy Bed Kits Due to Tip-Over and Entrapment Hazards (Recall Alert)
Furniture·2,300 affected·Jan 25, 2018
Medium RiskCPSC
Walmart, Kmart, Meijer, Mills Fleet Farm, Seventh Avenue, And Online At Amazon.com And Zulily.com From November 2015 Through November 2017 For About $8.
VTech Recalls Infant Rattles Due to Choking Hazard
Children's Products·280,000 affected·Jan 25, 2018
RecallCPSC
Kmart, Walmart And Online At Amazon.com And Zulily.com From February 2017 Through November 2017 For About $25.
VTech Recalls Lights & Lullabies Travel Mobiles Due to Injury Hazard
Consumer Products·37,000 affected·Jan 25, 2018
High RiskFDA
General Mills, Inc
Larabar Chocolate Chip Cookie Dough, 5 - 1.6 oz (45g) bars Net Wt 8.0 oz(226g), UPC 21908-48817. Case UPC 000-21908-41675-5
Bakery & Grains·147 affected·Jan 25, 2018
High RiskFDA
Coblentz Distributing Inc Dba Walnut Creek Foods
WALNUT CREEK FOODS Caramel Popcorn NET WT 15 OZ (425g) Ingredients: Evaporated Can Juice, Popcorn, Butter (cream, salt), Salt, Sodium Bic...
Dairy·324 affected·Jan 25, 2018
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets...
Oral Drugs·7,174 affected·Jan 25, 2018
High RiskFDA
Ge Healthcare
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays me...
Medical Devices·44 affected·Jan 25, 2018
High RiskFDA
Stryker Corporation
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Spor...
Medical Implants·155 affected·Jan 25, 2018
RecallCPSC
Bonita Marie Int., Gamestop, Wonderland Stores And Others Nationwide And Online At Amazon.com And Other Websites From September 2017 Through November 2017 For Between $7 And $10.
Fashion Accessory Bazaar Recalls Fidget Spinner Keychains Due to Choking Hazard
Consumer Products·20,000 affected·Jan 24, 2018
CriticalFDA
Panera, Llc
Panera Reduced-Fat Plain Cream Cheese, 2 oz. and 8 oz.
Dairy·120,783 affected·Jan 24, 2018
High RiskFDA
Bell Plantation Inc.
Ready-to-Eat Powdered Peanut Butter in 1 lb (16 oz.) plastic jars
Dairy·6,011 affected·Jan 24, 2018
CriticalFDA
Panera, Llc
Panera Plain Cream Cheese, 2 oz. and 8 oz.
Dairy·120,783 affected·Jan 24, 2018