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High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·2,088 affected·Dec 21, 2015
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·7,850 affected·Dec 21, 2015
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·12,285 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in ...
Diagnostic Devices·1,009 affected·Dec 21, 2015
High RiskFDA
Baxter Corporation Englewood
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Medical Devices·4,695 affected·Dec 21, 2015
High RiskFDA
Northeast Laboratory Services, Inc.
NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemo...
Medical Devices·11,720 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry Syste...
Diagnostic Devices·994 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro...
Diagnostic Devices·885 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, ...
Diagnostic Devices·802 affected·Dec 21, 2015
High RiskFDA
Acist Medical Systems
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only...
Surgical Devices·48,614 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitr...
Diagnostic Devices·163 affected·Dec 21, 2015
High RiskFDA
Northeast Laboratory Services, Inc.
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemo...
Medical Devices·9,300 affected·Dec 21, 2015
High RiskFDA
Conmed Corporation
Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number H...
Surgical Devices·991 affected·Dec 21, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked Baguette 22202, 25 UNITS - 8.75 OZ, NET WT. 13.67 LB (6.2 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Sub Grande 22089; 36 UNITS - 5.9 OZ, NET WT. 13.27 LB (6.02 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Petit Pain 22203, 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 UNITS - 1.25 OZ, NET WT. 18.75 LB (8.5 kg), in a ca...
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked Assorted Dinner Rolls 22213; 240 UNITS - NET WT. 22.5 LB (10.2 kg), packed in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Mini Baguette 22205; 48 UNITS - 5 OZ, NET WT. 15 LB (6.8 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Dinner Roll 22245; 120 units - 1.25 OZ NET WT. 9.37 LB (4.25 KG), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Sub Roll 22201, 72 UNITS - 3.25 OZ, NET WT. 14.62 LB (6.63 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked Assorted Petit Pain 22032; 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Cyberonics, Inc
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Medical Devices·4,935 affected·Dec 18, 2015
High RiskFDA
Instrumentation Laboratory Co.
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and ...
Diagnostic Devices·108 affected·Dec 18, 2015
High RiskFDA
Endochoice, Inc.
Fuse 1C Colonoscope
Medical Devices·253 affected·Dec 18, 2015
High RiskFDA
Value Plastics, Inc.
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, ...
Medical Devices·33,000 affected·Dec 18, 2015
High RiskFDA
C.r. Bard, Inc.
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization f...
Surgical Devices·1,428,000 affected·Dec 18, 2015
High RiskFDA
Stryker Spine
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitat...
Medical Devices·31 affected·Dec 18, 2015
High RiskFDA
Swinomish Fish Company, Inc
Native Catch Salmon Bacon, Traditional flavor. UPC 7 83583 27965 9. Traditional Salmon Bacon is ground and seasoned skinless/boneles...
Seafood·66 affected·Dec 17, 2015
High RiskFDA
Swinomish Fish Company, Inc
Native Catch Salmon Bacon, Peppered flavor. UPC: 7 51778 15900 0. Peppered Salmon Bacon is ground and seasoned skinless/boneless salm...
Seafood·67 affected·Dec 17, 2015
High RiskFDA
Arthrex, Inc.
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 -...
Medical Implants·2,378 affected·Dec 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Medical Devices·677 affected·Dec 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Medical Devices·427 affected·Dec 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Medical Devices·117 affected·Dec 17, 2015
High RiskFDA
Merge Healthcare, Inc.
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30...
Medical Devices·164 affected·Dec 17, 2015
High RiskFDA
Ge Inspection Technologies, Lp
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Medical Devices·55 affected·Dec 16, 2015
High RiskFDA
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid and rescue IABP
Medical Devices·1,243 affected·Dec 16, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia...
Respiratory Devices·84 affected·Dec 15, 2015
High RiskFDA
Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions an...
Medical Devices·25 affected·Dec 15, 2015
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Medical Devices·14,094 affected·Dec 15, 2015
High RiskFDA
Globalmed Logistix
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Medical Devices·118 affected·Dec 15, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesi...
Respiratory Devices·2 affected·Dec 15, 2015
High RiskFDA
Bd Diagnostic
BD Viper LT software, version 3.00H
Medical Devices·2 affected·Dec 14, 2015
High RiskFDA
Benlan, Inc.
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral ...
Medical Devices·120 affected·Dec 11, 2015
High RiskFDA
A.r.food Brokerage Corp.
Label reading in part: "ECONO***Gandules Verde***Hervidos en Agua y Sal*** Green Pigeon Peas***PREMIUM***NET WT. 15 oz (425g)***PRODUCTO ...
Food·4,052 affected·Dec 10, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing ...
Cardiac Devices·5 affected·Dec 10, 2015
High RiskFDA
Ascom Us, Inc.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Medical Devices·319 affected·Dec 10, 2015
High RiskFDA
Iba Dosimetry Gmbh
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Medical Devices·0 affected·Dec 10, 2015