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High RiskFDA
Black River Industries
Sweet Basil Leaf in 2 Lb. plastic bottles and 25 pound bulk boxes.
Food·80 affected·Nov 8, 2018
High RiskFDA
Allergan
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Path...
Injectable Drugs·111,132 affected·Nov 8, 2018
High RiskFDA
Icu Medical Inc
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indi...
Medical Devices·31,050 affected·Nov 8, 2018
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Sri...
Oral Drugs·4,212 affected·Nov 7, 2018
High RiskFDA
Hager & Meisinger Gmbh
Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/1...
Medical Devices·2,500 affected·Nov 7, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Diagnostic Devices·146 affected·Nov 7, 2018
High RiskFDA
L. Perrigo Company
Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed b...
Oral Drugs·70,170 affected·Nov 6, 2018
High RiskFDA
The Binding Site Group, Ltd.
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrato...
Medical Devices·60 affected·Nov 6, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 a...
Surgical Devices·15 affected·Nov 6, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are i...
Surgical Devices·14 affected·Nov 6, 2018
High RiskFDA
Conagra Foods, Inc.
Duncan Hines Classic Classic Yellow cake mix 15.25oz. 12 retail units per case 644209307494
Bakery & Grains·56,645 affected·Nov 5, 2018
High RiskFDA
Conagra Foods, Inc.
Duncan Hines Classic Classic White cake mix 15.25oz. 12 retail units per case 644209307500
Bakery & Grains·102,674 affected·Nov 5, 2018
High RiskFDA
Cedar Lake Tea
Apricot Chai Tea, 8 oz. Loose. UPC 41427-96317
Beverages·34 affected·Nov 5, 2018
High RiskFDA
Conagra Foods, Inc.
Duncan Hines Signature Confetti Cake cake mix 15.25oz. 12 retail units per case 644209414550
Bakery & Grains·11,295 affected·Nov 5, 2018
High RiskFDA
Conagra Foods, Inc.
Duncan Hines Classic Butter Golden cake mix 15.25oz. 12 retail units per case 644209307593
Dairy·34,927 affected·Nov 5, 2018
High RiskFDA
Capintec Inc
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Medical Devices·65 affected·Nov 5, 2018
High RiskFDA
Covidien Llc
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Surgical Devices·32,071 affected·Nov 5, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Medical Devices·9,097 affected·Nov 5, 2018
High RiskFDA
Bound Tree Medical, Llc
Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 V...
Injectable Drugs·339 affected·Nov 2, 2018
High RiskFDA
Bound Tree Medical, Llc
Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, ...
Drugs·2,654 affected·Nov 2, 2018
High RiskFDA
Bound Tree Medical, Llc
curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Trainin...
Drugs·1,283 affected·Nov 2, 2018
High RiskFDA
Golden State Medical Supply Inc.
IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: S...
Oral Drugs·12,502 affected·Nov 2, 2018
High RiskFDA
Bound Tree Medical, Llc
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 A...
Drugs·7,063 affected·Nov 2, 2018
High RiskFDA
Sandoz Inc
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Labora...
Oral Drugs·1,550 affected·Nov 2, 2018
High RiskFDA
Sandoz Inc
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Labora...
Oral Drugs·5,100 affected·Nov 2, 2018
High RiskFDA
Golden State Medical Supply Inc.
IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: S...
Oral Drugs·15,917 affected·Nov 2, 2018
High RiskFDA
Golden State Medical Supply Inc.
IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by...
Oral Drugs·2,439 affected·Nov 2, 2018
High RiskFDA
Sandoz Inc
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
Oral Drugs·18,832 affected·Nov 2, 2018
High RiskFDA
Sandoz Inc
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laborat...
Oral Drugs·7,817 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. ...
Medical Devices·115 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
Medical Devices·135 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
Medical Devices·73 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transdu...
Medical Devices·297 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
Medical Devices·49 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 ...
Medical Devices·20 affected·Nov 2, 2018
High RiskFDA
Ascom (us) Inc.
Ascom Telligence Nurse Call System
Medical Devices·57 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) n...
Medical Devices·234 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-...
Medical Devices·1,375 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) wi...
Medical Devices·468 affected·Nov 2, 2018
High RiskFDA
Stephanix
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Rem...
Diagnostic Devices·17 affected·Nov 2, 2018
High RiskFDA
Sysco Charlotte
Belgioioso CHEESE GORGONZOLA WHEEL HALF 8#
Dairy·20 affected·Nov 1, 2018
High RiskFDA
Sysco Charlotte
LIGHT COW CHEESE LAUGHING COW BAY BEL¿
Dairy·1 affected·Nov 1, 2018
High RiskFDA
Sysco Charlotte
Chicken of the Sea CRAB MEAT SUPER LUMP PSTRZD
Meat & Poultry·4 affected·Nov 1, 2018
High RiskFDA
Sysco Charlotte
Sea Wings CRAB MEAT PAST SUPER LUMP ASIA
Meat & Poultry·22 affected·Nov 1, 2018
High RiskFDA
Sysco Charlotte
Sea Wings CRAB MEAT CLAW PAST ASIA
Meat & Poultry·184 affected·Nov 1, 2018
High RiskFDA
Sysco Charlotte
Packer Apple Fresh Slices
Food·2 affected·Nov 1, 2018
High RiskFDA
Sysco Charlotte
Rivoire CHEESE GRUYERE COMTE BLOCKS 3.5#
Dairy·7 affected·Nov 1, 2018
High RiskFDA
Sysco Charlotte
Yoplait YOGURT VANILLA PARFAIT POUCH
Dairy·309 affected·Nov 1, 2018