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High RiskFDA
Datascope Corporation
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a c...
Cardiac Devices·996 affected·Apr 12, 2017
High RiskFDA
Medline Industries, Inc.
PICC Tray, STERILE, 12 packs each per case.
Medical Devices·144 affected·Apr 12, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM...
Cardiac Devices·3,096 affected·Apr 11, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM ...
Cardiac Devices·37 affected·Apr 11, 2017
High RiskFDA
Biomet Microfixation, Llc
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Surgical Devices·33 affected·Apr 11, 2017
High RiskFDA
Vertical Pharmaceuticals, Inc.
Vertical Pharmaceuticals OB Complete with DHA Prenatal Multivitamin, 60 softgels Rx Only, Manufactured for: Vertical Pharmaceuticals, LLC...
Supplements·5,734 affected·Apr 10, 2017
High RiskFDA
Quaker Oats Co
Tropicana 100% JUICE, orange juice From Concentrate with Other Natural Flavors, 24-10 FL OZ (296 mL) BOTTLES, (TOTAL 240 FL OZ (1.8 GAL) ...
Beverages·3,730 affected·Apr 10, 2017
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system test...
Medical Devices·159 affected·Apr 10, 2017
High RiskFDA
B Braun Medical Inc
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Medical Devices·417,600 affected·Apr 10, 2017
High RiskFDA
Fagron, Inc
Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (...
Drugs·1,313 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric ...
Injectable Drugs·851 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT...
Injectable Drugs·1,951 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solut...
Injectable Drugs·2,156 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 240...
Injectable Drugs·2,335 affected·Apr 6, 2017
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride...
Drugs·590 affected·Apr 6, 2017
High RiskFDA
Fagron, Inc
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle ...
Drugs·15,283 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2...
Injectable Drugs·4,001 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutio...
Ophthalmic Drugs·5,165 affected·Apr 6, 2017
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride...
Drugs·295 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2...
Injectable Drugs·2,352 affected·Apr 6, 2017
High RiskFDA
Amendia, Inc
01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 17...
Medical Implants·15 affected·Apr 6, 2017
High RiskFDA
Fresh Express Incorpated
Organic Marketside Spring Mix, net Wt. 5 oz. (142g) packed in rigid plastic container, UPC code 6 8113132897 5.
Food·1,019 affected·Apr 5, 2017
High RiskFDA
Malgor & Co., Inc.
Cedeira Octopus in Oil Spiced Piquant, Net Weight 4.4oz (125g)
Food·1,008 affected·Apr 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determ...
Diabetes Devices·0 affected·Apr 5, 2017
High RiskFDA
Bausch & Lomb Surgical, Inc.
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece ...
Medical Devices·0 affected·Apr 5, 2017
High RiskFDA
Boston Scientific Corporation
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral v...
Surgical Devices·137 affected·Apr 5, 2017
High RiskFDA
Perouse Medical
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 01...
Medical Devices·18,431 affected·Apr 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Diabetes Devices·0 affected·Apr 5, 2017
High RiskFDA
Diagnostic Hybrids, Inc.
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The...
Diagnostic Devices·101 affected·Apr 4, 2017
High RiskFDA
Smiths Medical Asd Inc.
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Medical Devices·736,000 affected·Apr 4, 2017
High RiskFDA
Lakeside Foods, Inc
Season's Choice Garden Fresh Sweet Peas, Net Wt 16 oz (1lb) 454g, Keep Frozen. UPC 41498-164294.
Frozen Food·1,920 affected·Apr 3, 2017
High RiskFDA
Medisca, Inc.
ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10...
Drugs·0 affected·Apr 3, 2017
High RiskFDA
Cell Distributors
Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784...
Ophthalmic Drugs·2,634 affected·Apr 3, 2017
High RiskFDA
Medisca, Inc.
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), an...
Drugs·0 affected·Apr 3, 2017
High RiskFDA
Medisca, Inc.
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATT...
Drugs·0 affected·Apr 3, 2017
High RiskFDA
Medisca, Inc.
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 387...
Drugs·0 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) conc...
Diagnostic Devices·12,665 affected·Apr 3, 2017
High RiskFDA
Intersurgical Inc
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pe...
Medical Devices·144 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human ser...
Diagnostic Devices·50,645 affected·Apr 3, 2017
High RiskFDA
Mederi Therapeutics, Inc
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesopha...
Surgical Devices·1,458 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high dens...
Diagnostic Devices·91,996 affected·Apr 3, 2017
High RiskFDA
Natus Medical Incorporated
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part N...
Medical Devices·4,371 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human se...
Diagnostic Devices·128,718 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for...
Diagnostic Devices·188 affected·Apr 3, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon Pro, Part No. 10270012
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon 5 Pro, Part No. 10270015
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Medical Devices·293,867 affected·Apr 1, 2017