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High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, N...
Injectable Drugs·597,498 affected·Mar 18, 2015
High RiskFDA
Hansen Medical Inc
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Surgical Devices·19 affected·Mar 18, 2015
High RiskFDA
Biomet, Inc.
LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and h...
Medical Devices·45 affected·Mar 18, 2015
High RiskFDA
Zimmer Gmbh
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Medical Devices·30 affected·Mar 18, 2015
High RiskFDA
Kraft Foods Group Inc.
Kraft Macaroni & Cheese Boxed Dinner Original Flavor, 7.25oz.,packaged in blue and yellow cardboard box. There are four different package...
Dairy·242,000 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·4 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·70 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injecti...
Injectable Drugs·43 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·12 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mc...
Injectable Drugs·56 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·8 affected·Mar 17, 2015
High RiskFDA
Akorn, Inc.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx ...
Oral Drugs·8,400 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·8 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·6 affected·Mar 17, 2015
High RiskFDA
Akorn, Inc.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16)...
Oral Drugs·326,666 affected·Mar 17, 2015
High RiskFDA
Akorn, Inc.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16...
Oral Drugs·27,648 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·15 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·30 affected·Mar 17, 2015
High RiskFDA
American Catheter Corp
American Catheter / Cholangiogram Catheter 9100 Series.
Surgical Devices·890 affected·Mar 17, 2015
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac paci...
Medical Implants·6,040 affected·Mar 17, 2015
High RiskFDA
Bard Peripheral Vascular Inc
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: ...
Medical Devices·29,342 affected·Mar 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by c...
Medical Devices·79 affected·Mar 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Medical Devices·66 affected·Mar 17, 2015
High RiskFDA
Drake's Fresh Pasta Company, Inc.
Cheese Ravioli, RV 301, 96 Ct. Deep Frozen, MF# RV301 and Frozen Cheese Ravioli (Jumbo) Mama Ricottas, MF# RV366, 192 ct., Manufactured b...
Dairy·169 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstru...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstru...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with...
Medical Devices·2,611 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruct...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Arcos, Inc
Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn ...
Medical Devices·28 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruct...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover ...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstructi...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Diasorin Inc.
DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro ...
Diagnostic Devices·451 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of s...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction ...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgi...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a va...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of sur...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Gourmet Kitchen, Inc.
Lobster & Shrimp Spring Rolls Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
Seafood·120 affected·Mar 15, 2015
High RiskFDA
Gourmet Kitchen, Inc.
Spicy Shrimp Chopsticks 80 PCS S5038 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & s...
Seafood·394 affected·Mar 15, 2015
High RiskFDA
Gourmet Kitchen, Inc.
Spinach & Goat Cheese Pizza (Focaccia) Mackenzie Limited Spinach & Goat Cheese Focaccia 18 PCS #SGC18 Products are placed on plastic t...
Dairy·176 affected·Mar 15, 2015
High RiskFDA
Gourmet Kitchen, Inc.
Shrimp Maui; Maui Shrimp 100 pcs S5036 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shri...
Seafood·135 affected·Mar 15, 2015
High RiskFDA
Gourmet Kitchen, Inc.
Asparagus Roll Ups; Asparagus Roll-Up 100 PCS v2002 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelle...
Food·315 affected·Mar 15, 2015
High RiskFDA
Focus Diagnostics Inc
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Diagnostic Devices·300 affected·Mar 15, 2015
High RiskFDA
Prothera, Inc.
Klaire Labs Ther-Biotic Children's Chewable 125+ Billion CFU's Multi-Species Probiotic Supplement 60 Chewable Capsules. UPC 7 09616 01...
Supplements·3,484 affected·Mar 13, 2015