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High RiskFDA
Biomet, Inc.
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System,...
Medical Implants·76 affected·Apr 17, 2020
High RiskFDA
Alcon Research Llc
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIG...
Medical Devices·84 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Stand...
Medical Implants·91 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: ...
Medical Implants·1 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibi...
Medical Implants·11 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vangua...
Medical Implants·105 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Medical Implants·12 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Com...
Medical Implants·54 affected·Apr 17, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Medical Devices·20 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArCo...
Medical Devices·122 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 6...
Medical Devices·46 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Sys...
Medical Devices·2,361,885 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial...
Medical Devices·107 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip S...
Medical Devices·58 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prost...
Medical Implants·15 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatmen...
Medical Devices·53,895 affected·Apr 17, 2020
RecallCPSC
Online At Amazon.com From January 2020 Through March 2020 For About $17.
Dr. Adorable Recalls Sweet Birch Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively on Amazon.com (Recall Alert)
Children's Products·12 affected·Apr 16, 2020
RecallCPSC
Ace Hardware, Menards, Tru Value, Do It Best, Fred Meyer, And Other Stores Nationwide From November 2019 Through January 2020 For Between $109 And $190.
MTD Southwest Recalls Trimmers and Polesaws Due to Laceration Hazard
Tools·2,660 affected·Apr 16, 2020
CriticalCPSC
Polaris Dealers Nationwide From October 2016 Through October 2019 For Between $15,300 And $27,500.
Polaris Recalls Model Year 2018 to 2020 Ranger XP 1000 Off-Road Vehicles Due to Fire Hazard (Recall Alert)
Vehicles / Atvs·80,000 affected·Apr 16, 2020
CriticalCPSC
Polaris Dealers Nationwide From August 2019 Through December 2019 For Between $15,890 And $29,000.
Polaris Recalls Model Year 2019 to 2020 Ranger XP 1000 Off-Road Vehicles Due to Fire Hazard (Recall Alert)
Vehicles / Atvs·7,000 affected·Apr 16, 2020
RecallCPSC
Polaris Dealers Nationwide From October 2019 Through December 2019 For Between $9,500 And $24,000.
Polaris Recalls PRO XD and Ranger Utility Vehicles Due to Injury Hazard (Recall Alert)
Vehicles / Atvs·10,100 affected·Apr 16, 2020
RecallCPSC
The Vitamin Shoppe Stores Nationwide And Online At Vitaminshoppe.com From April 2019 Through January 2020 For Between $15 And $22.
The Vitamin Shoppe Recalls Energy Formula Multivitamins Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
Children's Products·2,800 affected·Apr 16, 2020
RecallCPSC
Grocery Stores And Online At Amazon.com And Wyndmerenaturals.com From January 2020 Through March 2020 For Between $7 And $12.
Wyndmere Naturals Recalls Birch Sweet Essential Oil and Aches & Pains Synergistic Essential Oil Blend Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
Children's Products·2,850 affected·Apr 16, 2020
CriticalFDA
Whole Foods Market
Whole Foods Market Queso Sauce PLU code printed on the product scale labels beginning with 74135 sold in clear plastic deli-style contain...
Food·9 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
Medical Devices·0 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Becton Dickinson & Company
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Medical Devices·16,099,310 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Absorb Health Llc
Absorb Health Advanced Joint Relief Joint Health; 510mg; 90 CAPSULES; Manufactured for: Absorb Health, 106 Countryside St NW, Supply, NC ...
Food·70 affected·Apr 15, 2020
RecallFDA
Dole Fresh Vegetables Inc
Hearts of Romaine. Product is fresh and packaged in 9 ounce (255g) plastic bags.
Food·6 affected·Apr 15, 2020
RecallFDA
Dole Fresh Vegetables Inc
Dole "Classic Kit Light Cesar" fresh salad mix. Salad and topping Net Wt.7.7 OZ (218g), Dressing Net 2.2 FL OZ (65ml), Total Net Wt. 10 O...
Produce·6 affected·Apr 15, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807...
Oral Drugs·11,258 affected·Apr 15, 2020
CriticalFDA
Summitt Labs
KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.81...
Drugs·236 affected·Apr 15, 2020
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-...
Oral Drugs·9,000 affected·Apr 15, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United State...
Oral Drugs·4,518 affected·Apr 15, 2020
High RiskFDA
B & B Pharmaceuticals, Inc.
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams...
Drugs·3,825 affected·Apr 14, 2020
CriticalFDA
Masterpharm Llc
Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty ...
Oral Drugs·7,260 affected·Apr 14, 2020
High RiskFDA
Becton Dickinson & Co.
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Ki...
Diagnostic Devices·10,568 affected·Apr 14, 2020
High RiskFDA
Becton Dickinson & Co.
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kit...
Diagnostic Devices·236 affected·Apr 14, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical person...
Cardiac Devices·94,034 affected·Apr 13, 2020