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High RiskFDA
Howmedica Osteonics Corp.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthr...
Medical Implants·6 affected·Jan 12, 2018
High RiskFDA
Medline Industries, Inc.
BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
Medical Devices·6 affected·Jan 12, 2018
High RiskFDA
Cook Inc.
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator inte...
Medical Devices·4,451 affected·Jan 12, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interv...
Cardiac Devices·16 affected·Jan 12, 2018
High RiskFDA
Shimadzu Medical Systems
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiogra...
Medical Devices·17 affected·Jan 12, 2018
High RiskFDA
Alcon Research, Ltd.
Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION V...
Medical Devices·300 affected·Jan 12, 2018
High RiskFDA
Hill-rom, Inc.
Progressa Bed - AC-powered adjustable hospital bed
Medical Devices·2,117 affected·Jan 12, 2018
High RiskFDA
Alcon Research, Ltd.
Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrec...
Medical Devices·52 affected·Jan 12, 2018
High RiskFDA
Tecan Us, Inc.
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro ...
Diagnostic Devices·870 affected·Jan 12, 2018
High RiskFDA
Flexfrost
Flexfrost Protein Ice Cream Mint Chip Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
Dairy·960 affected·Jan 11, 2018
High RiskFDA
Flexfrost
Flexfrost Protein Ice Cream Coffee Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
Dairy·3,120 affected·Jan 11, 2018
High RiskFDA
Flexfrost
Flexfrost Protein Ice Cream Vanilla Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
Dairy·2,927 affected·Jan 11, 2018
High RiskFDA
Aveka Nutra Processing
SAF PRO RELAX +YF, Deactivated Dry Yeast, Product Code 73050, Net Wt. 50 LBS. (22.7 KG), manufactured for Lesaffre Yeast Company, Milwauk...
Food·3,128 affected·Jan 11, 2018
High RiskFDA
Flexfrost
Flexfrost Protein Ice Cream Chocolate Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
Dairy·1,200 affected·Jan 11, 2018
High RiskFDA
Flexfrost
Flexfrost Protein Ice Cream Cinnamon Chai Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
Dairy·440 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time C...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time C...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coas...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, F...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time C...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brow...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and...
Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, ...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wache...
Drugs·193 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coast...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), ...
Oral Drugs·0 affected·Jan 11, 2018
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) ...
Drugs·0 affected·Jan 11, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Medical Devices·63 affected·Jan 11, 2018
High RiskFDA
Ellex Iscience, Inc.
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScien...
Surgical Devices·90 affected·Jan 11, 2018
High RiskFDA
Claudio Wholesale, Inc. (dba) Claudio Specialty Foods
Sapori di Mare Colatura di Alici di Cetura; Anchovy Sauce; 100 ml, Lot #'s 03/2017 or 09/2017.
Food·216 affected·Jan 10, 2018
High RiskFDA
Aryzta North America
Italian White Bread Dough Sticks
Bakery & Grains·1,173 affected·Jan 10, 2018
High RiskFDA
Aryzta North America
Italian White Bread Dough Sticks
Bakery & Grains·1,872 affected·Jan 10, 2018
High RiskFDA
Spirit Pharmaceuticals, Llc
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Oral Drugs·144 affected·Jan 10, 2018
High RiskFDA
Hetero Labs, Ltd. - Unit Iii
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Het...
Oral Drugs·3,000 affected·Jan 10, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Medical Devices·7,020 affected·Jan 10, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Medical Devices·180 affected·Jan 10, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a st...
Medical Devices·165 affected·Jan 10, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·23,088,900 affected·Jan 9, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packagin...
Oral Drugs·2,853,500 affected·Jan 9, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·52,549,000 affected·Jan 9, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·205,088,000 affected·Jan 9, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·4,127,500 affected·Jan 9, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·21,584,100 affected·Jan 9, 2018
High RiskFDA
Hom'ade Foods
Mary B's Thins , 22 Biscuits, NET WT. 28.3 oz (1LB 12.3 OZ) 810g
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Butter Taste, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12 OZ)1247g; and Mary B's Butter Taste, 30 Biscuits, Family Pack, NET ...
Dairy·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Jumbo, 10 Biscuits, Extra Large, NET WT. 35 oz (2LB 3OZ) 992g
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Buttermilk, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Buttermilk, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12...
Dairy·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Buttermilk 0 Trans Fat 220 CT, Bulk Biscuits
Dairy·562,302 affected·Jan 8, 2018