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High RiskFDA
Philips Medical Systems (cleveland) Inc
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by com...
Medical Devices·257 affected·Aug 31, 2012
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and ...
Medical Devices·124 affected·Aug 31, 2012
High RiskFDA
Accuro Medical Product Llc
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 6...
Medical Devices·919 affected·Aug 31, 2012
High RiskFDA
Zimmer, Inc.
Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and se...
Surgical Devices·195 affected·Aug 31, 2012
High RiskFDA
Stryker Sustainability Solutions
STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT...
Medical Devices·1,311 affected·Aug 30, 2012
High RiskFDA
Medtronic Sofamor Danek Usa Inc
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc....
Medical Devices·1,014 affected·Aug 30, 2012
High RiskFDA
Medtronic Sofamor Danek Usa Inc
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid...
Medical Devices·247 affected·Aug 30, 2012
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL ...
Injectable Drugs·148,630 affected·Aug 29, 2012
High RiskFDA
Sadie's Salads
Sadie's Salads Macaroni and Cheese, 5 lb and 10 lb plastic tubs
Dairy·0 affected·Aug 28, 2012
High RiskFDA
Sadie's Salads
Sadie's Salads Macaroni Salad, 5 lb, 10 lb and 30 lb plastic tubs
Produce·0 affected·Aug 28, 2012
High RiskFDA
Sadie's Salads
Sadie's Salads No Sugar Vegetable Pasta Salad, 4 lb and 8 lb plastic tubs
Produce·0 affected·Aug 28, 2012
High RiskFDA
Sadie's Salads
Sadie's Salads Egg Salad, 5 lb, 10 lb plastic tubs
Produce·0 affected·Aug 28, 2012
High RiskFDA
Meijer Distribution, Inc
Product Name: Walnuts 160z. Brand Name: Markets of Meijer Meijer Distribution, Inc. Grand Rapids, MI49544 UPC 8-8692619782-2
Food·1,440 affected·Aug 28, 2012
High RiskFDA
Sadie's Salads
Sadie's Salads Egg-N-Olive Salad, 5 lb, 10 lb plastic tubs
Produce·0 affected·Aug 28, 2012
High RiskFDA
Sadie's Salads
Sadie's Salads Potato Salad, 5 lb, 10 lb and 30 lb plastic tubs
Produce·0 affected·Aug 28, 2012
High RiskFDA
James G. Cole, Inc.
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Drugs·253 affected·Aug 28, 2012
High RiskFDA
Dispensing Solutions, Inc
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing S...
Drugs·18 affected·Aug 28, 2012
High RiskFDA
Hospira Inc.
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Injectable Drugs·172,350 affected·Aug 28, 2012
High RiskFDA
Hospira Inc.
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC...
Injectable Drugs·26,100 affected·Aug 28, 2012
High RiskFDA
Biomerieux Inc
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking ...
Medical Devices·350 affected·Aug 28, 2012
High RiskFDA
Hospira Inc.
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Medical Devices·191,094 affected·Aug 28, 2012
High RiskFDA
Spinefrontier, Inc.
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into ...
Medical Implants·17 affected·Aug 28, 2012
High RiskFDA
Friendly Ice Cream Corp.
Friendly's Fudge Nut Brownie Sundae Extreme, 48 oz. carton UPC: 0-29839-00657-1
Food·19,860 affected·Aug 27, 2012
High RiskFDA
Friendly Ice Cream Corp.
Friendly's Brand Nutty Caramel Crunch Sundae, 6 0z. UPC: 0-29839-00050 Weis Crunchy Caramel Nut Sundae, 6 0z cup UPC 0-41497-01573-3
Food·86,136 affected·Aug 27, 2012
High RiskFDA
Zimmer, Inc.
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip...
Medical Devices·1 affected·Aug 27, 2012
High RiskFDA
Spacelabs Healthcare, Llc
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the...
Medical Devices·527 affected·Aug 27, 2012
High RiskFDA
Cinnabar Specialty Foods Inc
Neera's Tikka Curry Rich and Creamy All Natural Simmering Sauce, 16 fluid ounces/ 473 ml. Packaged in jar. Packaged at 12/16oz units/case...
Meat & Poultry·79 affected·Aug 25, 2012
High RiskFDA
Iradimed Corporation
The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion adm...
Medical Devices·719 affected·Aug 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomograph...
Medical Devices·328 affected·Aug 24, 2012
High RiskFDA
Volcano Corporation
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607...
Medical Devices·1,020 affected·Aug 24, 2012
High RiskFDA
Biomet, Inc.
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and os...
Medical Devices·268 affected·Aug 23, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into...
Medical Devices·12 affected·Aug 22, 2012
High RiskFDA
Spinefrontier, Inc.
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to pla...
Medical Implants·19 affected·Aug 22, 2012
High RiskFDA
American Licorice Co
Original Snaps Classic Chewy Candy; packed in 5.5 oz bags, 4.5 oz theatre box and 12 oz. tins. UPC 5.5 oz - 4136408300; 4.5 oz Theatre...
Snacks & Candy·15 affected·Aug 21, 2012
High RiskFDA
Pacific Northwest Tofu, Llc
Stir Fried Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu ...
Food·0 affected·Aug 21, 2012
High RiskFDA
American Licorice Co
RED VINES Mixed Bites; Red and Black licorice mixed bites. UPC: 4136400288 and 4136451277. Family Mix Half Pallet; UPD 4136421697; Fam...
Food·1 affected·Aug 21, 2012
High RiskFDA
Pacific Northwest Tofu, Llc
Gourmet Firm Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tof...
Food·0 affected·Aug 21, 2012
High RiskFDA
American Licorice Co
Red Vines Black Licorice Twists; No preservatives and Always Fat Free Packaged in the following configurations: One Pound Pac: Red and...
Food·1 affected·Aug 21, 2012
High RiskFDA
Pacific Northwest Tofu, Llc
Teriyaki Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu So...
Food·32 affected·Aug 21, 2012
High RiskFDA
Pacific Northwest Tofu, Llc
Hot & Spicy Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu...
Food·10 affected·Aug 21, 2012
High RiskFDA
Ranbaxy Inc.
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, ...
Oral Drugs·32,208 affected·Aug 21, 2012
High RiskFDA
Caraco Pharmaceutical Laboratories Ltd.
Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-...
Oral Drugs·2,424 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) t...
Medical Devices·135,712 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) t...
Medical Devices·268,022 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissu...
Medical Devices·433,528 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) t...
Medical Devices·94,301 affected·Aug 21, 2012
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel &am...
Medical Devices·30 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) t...
Medical Devices·104,355 affected·Aug 21, 2012