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High RiskFDA
Orthopediatrics Corp
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic impl...
Medical Implants·969 affected·Aug 19, 2019
High RiskFDA
Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during...
Medical Devices·153 affected·Aug 19, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Medical Devices·305 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
Medical Devices·21 affected·Aug 19, 2019
RecallFDA
Coopersurgical, Inc.
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Surgical Devices·4,930 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
Medical Devices·78 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
Medical Devices·1 affected·Aug 19, 2019
High RiskFDA
Orthopediatrics Corp
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic impla...
Medical Implants·211 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
Medical Devices·236 affected·Aug 19, 2019
High RiskFDA
Pepsico Inc
Diet Mountain Dew (Dewnited Michigan) 20 oz. plastic bottle Promotional give away as individual units
Food·1,000 affected·Aug 16, 2019
High RiskFDA
Kashat Wholesale, Inc.
Ground Cinnamon 4oz plastic container 24 containers per wholesale case
Food·360 affected·Aug 16, 2019
High RiskFDA
Abbott Nutrition, Division Of Abbott Laboratories
Similac Pro-Sensitive, 2 fl. oz. plastic bottles packed 12 per carton.
Food·13,440 affected·Aug 16, 2019
High RiskFDA
Sca Pharmaceuticals, Llc
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuti...
Injectable Drugs·922 affected·Aug 16, 2019
High RiskFDA
Irrimax Corporation
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Medical Devices·1,031 affected·Aug 16, 2019
RecallCPSC
Authorized Ssr Motorsports Dealers Nationwide From February 2019 Through June 2019 For Between $800 And $1,200.
SSR Motorsports Recalls Off-Highway Competition Motorcycles Due to Crash and Injury Hazards (Recall Alert)
Vehicles / Atvs·420 affected·Aug 15, 2019
High RiskFDA
Awers Inc
Grained Salmon Caviar 95g (Sockeye Salmon Caviar), refrigerated, packed in a metal tin with Cyrillic lettering. The tin is green, with re...
Seafood·4,288 affected·Aug 15, 2019
High RiskFDA
Foremost Foods International, Inc.
Frozen Whole Yellow Tail Fusiler-200 Up
Frozen Food·43 affected·Aug 15, 2019
High RiskFDA
Normand-info S.a.s.u.
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Medical Devices·6,479 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
Medical Devices·0 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 65 mm Item # 195752
Medical Devices·857 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
Medical Devices·2 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Diagnostic Devices·0 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 75 mm Item # 195251
Medical Devices·110 affected·Aug 15, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Medical Devices·88 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 59 mm Item # 195750
Medical Devices·50 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 63 mm Item # 195245
Medical Devices·8 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 75mm Item # 195275
Medical Devices·369 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 87 mm Item # 195278
Medical Devices·78 affected·Aug 15, 2019
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
QuickGraft¿ Model # 430PST
Medical Devices·9 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 73 mm Item # 195250
Medical Devices·84 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Diagnostic Devices·2,581 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 83 mm Item # 195759
Medical Devices·384 affected·Aug 15, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Medical Devices·166 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
Medical Devices·906 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 91 mm Item # 195279
Medical Devices·82 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·25,840 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 79 mm Item # 195252
Medical Devices·99 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 67 mm Item # 195247
Medical Devices·74 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 83 mm Item # 195277
Medical Devices·180 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·486 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Diagnostic Devices·16,983 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
Medical Devices·1,282 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vit...
Diagnostic Devices·25,383 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 65 mm Item # 195246
Medical Devices·43 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 63mm Item # 195269
Medical Devices·322 affected·Aug 15, 2019
High RiskFDA
Bioseal Corporation
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XX...
Medical Devices·900 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
Medical Devices·1,210 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 69 mm Item # 195248
Medical Devices·123 affected·Aug 15, 2019