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High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product...
Surgical Devices·80,200 affected·Apr 24, 2018
High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product ...
Surgical Devices·23,150 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Th...
Medical Devices·2,772 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement The...
Medical Devices·1,256 affected·Apr 24, 2018
High RiskFDA
Ziegenfelder Company, Inc.
Budget $aver Monster Cherry-Pineapple Pops Net Contents 36 FL OZ
Food·2,340 affected·Apr 23, 2018
High RiskFDA
Ziegenfelder Company, Inc.
Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZ
Food·1,176 affected·Apr 23, 2018
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limite...
Oral Drugs·8,160 affected·Apr 23, 2018
High RiskFDA
Tandem Diabetes Care Inc
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary R...
Diabetes Devices·55 affected·Apr 23, 2018
High RiskFDA
Healthy Food Ingredients
Great Value Organic Ground Flax Seed, Net Wt. 16 oz. (1 LB) 454g. UPC 78742-14161, and Net Wt. 32 oz. (2 LB) 907g, UPC 78742-14165 Dist...
Food·8,182 affected·Apr 21, 2018
High RiskFDA
Exela Pharma Sciences Llc
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For...
Oral Drugs·5,256 affected·Apr 20, 2018
High RiskFDA
Pintler Medical Llc
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where pat...
Medical Devices·24 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Medical Devices·33 affected·Apr 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient resc...
Medical Devices·4 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LX...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox ...
Oral Drugs·1,908 affected·Apr 19, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Diagnostic Devices·7,543 affected·Apr 19, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, ...
Diagnostic Devices·20,373 affected·Apr 19, 2018
High RiskFDA
Microaire Surgical Instruments, Llc
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAir...
Medical Devices·2,009 affected·Apr 19, 2018
High RiskFDA
Maquet Sas
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part ...
Surgical Devices·187 affected·Apr 19, 2018
High RiskFDA
Eastland Food Corporation
Asian Best, Tamarind Candy Hot Flavor Net Weight: 4 oz. Units Per Carton: 72 units
Snacks & Candy·970 affected·Apr 18, 2018
High RiskFDA
Stuffed Foods Llc
Stuffed FOODS Edamame Burger, MFG ITEM # 06100 UPC: 108500821003752 3 - 3lb plastic bags in box
Food·1,552 affected·Apr 18, 2018
High RiskFDA
Naturebox, Inc.
Whole Wheat Chocolate Animal Cookies; 5 oz. pouch, 5 lb. Corporate bags UPC: 8 58950 00508 6 Ingredients: Whole Wheat Flour, Unbleac...
Dairy·1,034 affected·Apr 18, 2018
High RiskFDA
Canon Medical System, Usa, Inc.
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Medical Devices·43 affected·Apr 18, 2018
High RiskFDA
Shawnee Milling Company, Inc.
Hilltop Hearth Self-Rising Flour, Katy s Kitchen Self-Rising Flour, Springwell A1 Flour all packaged in 50 pound paper bags
Food·1,350 affected·Apr 17, 2018
High RiskFDA
Grato Holdings, Inc.
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Supplements·845 affected·Apr 16, 2018
High RiskFDA
Grand Canyon Foods International Llc.
Southwestern Gourmet Butter Popcorn Grand Canyon Foods, Phoenix, AZ
Dairy·898 affected·Apr 16, 2018
High RiskFDA
Traditional Medicinals Inc
Traditional Medinicals organic EveryDay Detox Lemon; Naturally Caffeine Free Herbal Tea; 16 wrapped tea bags - Herbal Supplement NET ...
Beverages·9,108 affected·Apr 16, 2018
High RiskFDA
Traditional Medicinals Inc
Traditional Medicinals Throat Coat Lemon Echinacea; Lemon Echinacea, Naturally Caffeine Free Herbal Tea' 16 wrapped tea bags - Herbal S...
Beverages·6,980 affected·Apr 16, 2018
High RiskFDA
Grand Canyon Foods International Llc.
Southwestern Gourmet Prickly Pear Popcorn Grand Canyon Foods, Phoenix, AZ
Snacks & Candy·2,079 affected·Apr 16, 2018
High RiskFDA
Grato Holdings, Inc.
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Supplements·27,860 affected·Apr 16, 2018
High RiskFDA
Grato Holdings, Inc.
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA ...
Supplements·32,213 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-4...
Medical Devices·40,738 affected·Apr 16, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Medical Implants·1 affected·Apr 16, 2018
High RiskFDA
Trimed Inc.
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation ...
Surgical Devices·722 affected·Apr 16, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Medical Implants·2 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-...
Medical Devices·81,338 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, ...
Medical Devices·131,093 affected·Apr 16, 2018
High RiskFDA
Spinal Elements
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Dev...
Medical Implants·19 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 10...
Medical Devices·22,132 affected·Apr 16, 2018
High RiskFDA
Cook Inc.
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 1082700252264...
Surgical Devices·40 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/1000431...
Medical Devices·68,117 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001,...
Medical Devices·37,485 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 10011620...
Medical Devices·139,351 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-3...
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring...
Cardiac Devices·986 affected·Apr 16, 2018