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High RiskFDA
Icu Medical, Inc.
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: ...
Medical Devices·600 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
Medical Devices·15 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Vasc Custom Kit - contains Devon Light Glove Used during surgery
Medical Devices·3 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Skin and Vein Pack - contains Devon Light Glove Used during surgery
Medical Devices·3 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery
Surgical Devices·4 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Head & Neck Pack - contains Devon Light Glove Used during surgery
Medical Devices·2 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Blepharoplasty Pack - contains Devon Light Glove Used during surgery
Medical Devices·1 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Bl...
Medical Devices·900 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Suction Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of...
Medical Devices·75 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
General Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Glaucoma Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
Medical Devices·3 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Pediatric Pack - contains Devon Light Glove Used during surgery
Medical Devices·1 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Custom Pack - contains Devon Light Glove Used during surgery
Medical Devices·1 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Medical Devices·13 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (Whit...
Medical Devices·1,500 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Standard Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 ...
Medical Devices·5,100 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Vein & Vascular Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Hand Pack - contains Devon Light Glove Used during surgery
Medical Devices·4 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
ENT Pack - contains Devon Light Glove Used during surgery
Medical Devices·2 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
Medical Devices·5 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Hand Pack - contains Devon Light Glove Used during surgery
Medical Devices·3 affected·Apr 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction o...
Medical Devices·75 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used dur...
Medical Devices·55 affected·Apr 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction ...
Medical Devices·75 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Face Lift Pack - contains Devon Light Glove Used during surgery
Medical Devices·0 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
Medical Devices·13,800 affected·Apr 20, 2015
High RiskFDA
Stradis Healthcare, Llc.
Podiatry Pack - contains Devon Light Glove Used during surgery
Medical Devices·4 affected·Apr 20, 2015
High RiskFDA
Guayaki S.r.p., Inc.
Guayaki Brand Yerba Mate - Revel Berry; 16 oz aluminum can, Best By 12SEP16. UPC 6 32432 73777 5 Guayaki Yerba Mate is a high energy...
Produce·26,641 affected·Apr 17, 2015
High RiskFDA
Valeant Pharmaceuticals North America Llc
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA...
Oral Drugs·93,237 affected·Apr 17, 2015
High RiskFDA
Spacelabs Healthcare Inc
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Modu...
Cardiac Devices·1,999 affected·Apr 17, 2015
High RiskFDA
Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Medical Devices·11 affected·Apr 17, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag...
Medical Devices·5,359 affected·Apr 17, 2015
High RiskFDA
Tarmac Products, Inc.
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle,
Topical Drugs·41,743 affected·Apr 16, 2015
High RiskFDA
Tarmac Products, Inc.
Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle
Drugs·16,248 affected·Apr 16, 2015
High RiskFDA
Tarmac Products, Inc.
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)
Topical Drugs·104,810 affected·Apr 16, 2015
High RiskFDA
Medtronic Neuromodulation
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Medical Devices·86,851 affected·Apr 16, 2015
High RiskFDA
Wright Medical Technology, Inc.
PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
Medical Devices·126 affected·Apr 16, 2015
High RiskFDA
Wright Medical Technology, Inc.
PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
Medical Devices·124 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 5000051...
Surgical Devices·4,136 affected·Apr 16, 2015
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Echelon MRI System
Medical Devices·68 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 57...
Medical Devices·77,588 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Cat...
Surgical Devices·26,108,946 affected·Apr 16, 2015
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Oasis MRI System
Medical Devices·210 affected·Apr 16, 2015