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High RiskFDA
Cardinal Health 200, Llc
ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up...
Medical Devices·3,236 affected·Mar 22, 2019
High RiskFDA
Stryker Communications
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provi...
Surgical Devices·946 affected·Mar 22, 2019
High RiskFDA
Microline Surgical, Inc.
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Medical Devices·115 affected·Mar 22, 2019
High RiskFDA
Impossible Foods
Impossible Foods Bulk, 5 lb. vacuum sealed plastic-pack. Keep Frozen; This is a plant product that is looks like and is used like groun...
Meat & Poultry·1,649 affected·Mar 21, 2019
High RiskFDA
Better Made Snack Foods Inc.
Better Made Snack Foods Family Size $3.99 Original Potato Chips 10oz. flexible pouch bag UPC code of 041633063048 12 bags per case
Snacks & Candy·660 affected·Mar 21, 2019
High RiskFDA
Conmed Corporation
ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED ...
Medical Devices·69,385 affected·Mar 21, 2019
High RiskFDA
Roi Consolidated Service Center (csc)
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow I...
Surgical Devices·312 affected·Mar 21, 2019
High RiskFDA
Conmed Corporation
ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED ...
Medical Devices·11,835 affected·Mar 21, 2019
High RiskFDA
Conmed Corporation
ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" b...
Medical Devices·2,931 affected·Mar 21, 2019
High RiskFDA
Community Products, Llc
Rifton TRAM Standard Base, SKU K310, powered lift device
Medical Devices·3,282 affected·Mar 21, 2019
High RiskFDA
Community Products, Llc
Rifton TRAM Low Base, SKU K320, powered lift device
Medical Devices·1,079 affected·Mar 21, 2019
High RiskFDA
Roi Consolidated Service Center (csc)
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High...
Surgical Devices·261 affected·Mar 21, 2019
High RiskFDA
Flowonix Medical Inc
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Medical Devices·809 affected·Mar 21, 2019
High RiskFDA
Conmed Corporation
ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED ...
Medical Devices·5,034 affected·Mar 21, 2019
High RiskFDA
Kingston Pharma Llc
DG health NATURALS For Infants 2+ Months+ baby Cough Syrup + Mucus, Natural Grape Flavor, 2 FL OZ (59 mL), UPC: 8 54954 00250 0, Product...
Baby Food & Formula·15,240 affected·Mar 20, 2019
High RiskFDA
Century Snacks Llc
Snak Club Honey Bliss Nut Mix: Honey Butter Flavored Almonds, Peanuts, Pumpkin Seeds, Pistachios, Pecans & Honey Sesame Sticks. NET WET...
Dairy·7,398 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Me...
Cardiac Devices·16 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health prof...
Medical Devices·27 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained h...
Medical Devices·11 affected·Mar 20, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR...
Medical Devices·120 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detect...
Medical Devices·35 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medici...
Medical Devices·37 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of rad...
Medical Devices·6 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radiois...
Medical Devices·31 affected·Mar 20, 2019
High RiskFDA
Lupin Somerset
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Labora...
Oral Drugs·76,422 affected·Mar 19, 2019
High RiskFDA
Allergan Sales, Llc
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S...
Ophthalmic Drugs·72 affected·Mar 19, 2019
High RiskFDA
Carestream Health, Inc.
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Conso...
Medical Devices·37 affected·Mar 19, 2019
High RiskFDA
Union Fish Company
Vega White Headless Shrimp, 21/15 and 26/30 count size. Frozen block in plastic bag, 6 x 4 lbs. per master carton. Product of the Phi...
Seafood·2,400 affected·Mar 18, 2019
High RiskFDA
Ideal Implant Incorporated
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc...
Medical Implants·1,704 affected·Mar 18, 2019
High RiskFDA
Opgen Inc
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic T...
Diagnostic Devices·80 affected·Mar 18, 2019
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer
Diagnostic Devices·149 affected·Mar 15, 2019
High RiskFDA
Biomerieux, Inc.
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the ide...
Diagnostic Devices·10,784 affected·Mar 15, 2019
High RiskFDA
Response Biomedical Corp.
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #0703...
Cardiac Devices·543 affected·Mar 15, 2019
High RiskFDA
Ge Healthcare, Llc
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiov...
Diagnostic Devices·22 affected·Mar 15, 2019
High RiskFDA
Remedyrepack Inc.
Losartan 50mg Tablet, 30 count each blister card.
Oral Drugs·33 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for pr...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prep...
Medical Implants·473 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prep...
Medical Implants·260 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteoto...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy ...
Medical Implants·264 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing os...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw...
Medical Implants·233 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific in...
Medical Devices·7 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepar...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Trilliant Surgical, Llc
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Medical Implants·20 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepa...
Medical Implants·8 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepari...
Medical Implants·8 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has...
Medical Implants·197 affected·Mar 14, 2019