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High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickn...
Medical Devices·126 affected·May 7, 2013
High RiskFDA
Zimmer Surgical Inc
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness ...
Medical Devices·84 affected·May 7, 2013
High RiskFDA
Spinefrontier, Inc.
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an...
Medical Implants·61 affected·May 7, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Medical Devices·4 affected·May 7, 2013
High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable gr...
Medical Devices·13 affected·May 7, 2013
High RiskFDA
Medical Information Technology, Inc.
MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) ...
Medical Devices·56 affected·May 7, 2013
High RiskFDA
Ortho-clinical Diagnostics
ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use w...
Diagnostic Devices·31 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Pro...
Diagnostic Devices·101 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm troca...
Medical Devices·2,716 affected·May 6, 2013
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive...
Surgical Devices·2,101 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm tr...
Medical Devices·5,364 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qua...
Diagnostic Devices·381 affected·May 6, 2013
High RiskFDA
Alphatec Spine, Inc.
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segm...
Medical Devices·1,814 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm tro...
Medical Devices·23,050 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quant...
Diagnostic Devices·69 affected·May 6, 2013
High RiskFDA
The Anspach Effort, Inc.
Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and...
Medical Devices·183 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are i...
Medical Devices·2,705 affected·May 6, 2013
High RiskFDA
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·45 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, an...
Diagnostic Devices·98 affected·May 6, 2013
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for In...
Surgical Devices·2,101 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are...
Medical Devices·126,925 affected·May 6, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the...
Medical Devices·17,719 affected·May 6, 2013
High RiskFDA
Nipro Medical Corporation
NIPRO Safe Touch Safety Scalp Vein Set
Medical Devices·176,000 affected·May 4, 2013
High RiskFDA
Green Mountain Coffee Roasters
Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Reta...
Food·288,144 affected·May 3, 2013
High RiskFDA
Gruma Corp
Senora Verde Taco Dinner Kit, 12ct, 9.75 oz (276g), 12 cartons per case.
Food·132 affected·May 3, 2013
High RiskFDA
Talenti Gelato
Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062
Produce·420 affected·May 3, 2013
High RiskFDA
Kareway Product Inc
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA -...
Drugs·24,048 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter...
Surgical Devices·4 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Can...
Medical Devices·73 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR...
Surgical Devices·6 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release H...
Surgical Devices·56 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment...
Medical Devices·229 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 ...
Medical Devices·2 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
Surgical Devices·10 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Ele...
Surgical Devices·447 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref....
Surgical Devices·34 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Respos...
Medical Devices·259 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122...
Medical Devices·907 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instr...
Surgical Devices·4 affected·May 3, 2013
High RiskFDA
Conmed Corporation
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunctio...
Cardiac Devices·49,010 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip A...
Surgical Devices·13 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Fla...
Medical Devices·90 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 -...
Surgical Devices·30 affected·May 3, 2013
High RiskFDA
Nestle Usa, Inc - Northbrook Pizza Head Office
california Pizza Kitchen crispy thin crust, White, Crispy thin crust pizza topped with garlic creme fraiche sauce, spinach, garlic, mozza...
Dairy·16,163 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·43 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·56 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·32 affected·May 2, 2013