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High RiskFDA
Siemens Healthcare Diagnostics Inc.
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use i...
Diagnostic Devices·1,555 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the...
Medical Devices·1,965 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior app...
Medical Devices·340 affected·May 15, 2020
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Medical Devices·8 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appr...
Medical Devices·495 affected·May 15, 2020
CriticalFDA
Ventura Foods Llc
Garlic Sauce; Net Wt. 8LB. (3.62 kg); PJ Item #1104; UPC 26700 16345; Manufactured for: PJ Foods Service, Inc; Louisville, KY 40299, USA....
Beverages·1,876 affected·May 14, 2020
High RiskFDA
Cj Haide (ningbo) Biotech Co., Ltd
Aminature L-Cysteine HCl Anhydrous 100 mesh 25KG DRUM
Food·40 affected·May 14, 2020
CriticalFDA
New Hoque & Sons, Inc.
"Radhuni Curry Powder, 400 grams (14.11 oz.)***Ingredients: Coriander, Tumeric, Chili, Bitsalt, Aniseed, Sodium Chloride, Garlic, Cumin, ...
Food·33 affected·May 14, 2020
RecallFDA
Invagen Pharmaceuticals, Inc.
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manuf...
Oral Drugs·2,202 affected·May 14, 2020
High RiskFDA
Neocis Inc.
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the p...
Medical Implants·70 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary i...
Medical Devices·3 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixati...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary interna...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for ...
Medical Devices·78 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary ...
Medical Devices·2 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary i...
Medical Devices·1 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary inte...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary in...
Medical Devices·1 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation a...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and...
Medical Devices·10 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for t...
Medical Devices·48 affected·May 14, 2020
High RiskFDA
Neocis Inc.
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the p...
Medical Implants·70 affected·May 14, 2020
High RiskFDA
Willamette Valley Pie Company, Llc.
Willamette Valley Pie Company Raspberry Rhubarb Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. a...
Beverages·48 affected·May 13, 2020
High RiskFDA
Willamette Valley Pie Company, Llc.
Willamette Valley Pie Company Cherry Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as ...
Beverages·48 affected·May 13, 2020
High RiskFDA
West-ward Columbus Inc
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx on...
Oral Drugs·68,376 affected·May 13, 2020
RecallFDA
West-ward Columbus Inc
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC...
Oral Drugs·3,336 affected·May 13, 2020
High RiskFDA
Johnson Sea Products, Inc.
Home Style Crab Cakes in a plastic wrapped foam tray, 12 oz. (Four, 3 oz. crab cakes per package). 12 packages per case.
Seafood·23 affected·May 12, 2020
CriticalFDA
Ramar International Corporation
Peekaboo Ice Cream + hidden Veggies; Organic Mint Chocolate Chip with Hidden Spinach, 14 oz. carton: UPC: 868540000115 Manufactured...
Dairy·255 affected·May 12, 2020
High RiskFDA
Diasorin Molecular Llc
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of vari...
Medical Devices·304 affected·May 12, 2020
High RiskFDA
Covidien Llc
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery pr...
Surgical Devices·12,610 affected·May 12, 2020
High RiskFDA
Diasorin Molecular Llc
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX...
Medical Devices·13,943 affected·May 12, 2020
CriticalFDA
Medtronic Vascular Galway Dba Medtronic Ireland
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Surgical Devices·103 affected·May 12, 2020
High RiskFDA
Covidien Llc
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic ...
Surgical Devices·12,610 affected·May 12, 2020
High RiskFDA
Med Tec Inc
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Medical Devices·171 affected·May 12, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Curcumin 50mg/mL, 10 mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Curcumin, 4mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Torrent Pharma Inc.
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130,...
Oral Drugs·6,228 affected·May 11, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use ...
Diagnostic Devices·0 affected·May 11, 2020
High RiskFDA
Biomet, Inc.
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640,...
Medical Implants·38 affected·May 11, 2020
CriticalFDA
K F K Seasonings Llc
Organic Ground Oregano, Item # 90206. Packaged in 40 lbs. or 50 lbs. cases and sold under brand KFK Seasoning. This product contains Or...
Food·500 affected·May 8, 2020
CriticalFDA
K F K Seasonings Llc
Chili Powder, Mild, Organic is a blend, Item # 90030. Packaged in 1 lb. bags and sold under brand Azure Market. This product contains "...
Food·96 affected·May 8, 2020
CriticalFDA
Icu Medical Inc
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Injectable Drugs·93,648 affected·May 8, 2020
High RiskFDA
Ge Healthcare
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional...
Cardiac Devices·221 affected·May 8, 2020
High RiskFDA
Merge Healthcare, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage...
Medical Devices·62 affected·May 8, 2020
High RiskFDA
Unfi General Corporate
Wild Harvest Organic Fresh Basil packaged in the following sized plastic containers: Net Wt 2 oz (57g), UPC 11535-50762, Net Wt 0.25...
Food·77 affected·May 7, 2020