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High RiskFDA
Zingerman's Bakehouse, Inc.
Zingerman's Bakehouse Graham Crackers 1 lb
Bakery & Grains·1 affected·Nov 2, 2012
High RiskFDA
Zingerman's Bakehouse, Inc.
Zingerman's Bakehouse Northern Corn Bread Net wt. 18 ounces
Bakery & Grains·18 affected·Nov 2, 2012
High RiskFDA
Zingerman's Bakehouse, Inc.
Zingerman's Bakehouse Country Scone Net wt. 3 ounces
Food·3 affected·Nov 2, 2012
High RiskFDA
Zingerman's Bakehouse, Inc.
Zingerman's Bakehouse Mary's Wild Oats Cranberry Almond Granola 1 lb
Bakery & Grains·1 affected·Nov 2, 2012
High RiskFDA
Bristol Myers Squibb Manufacturing Company
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC...
Oral Drugs·21 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Produ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
Del Mar Reynolds Medical, Ltd.
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both...
Respiratory Devices·3 affected·Nov 2, 2012
High RiskFDA
California Medical Laboratories Inc
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Surgical Devices·112,462 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70k...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50k...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
California Medical Laboratories Inc
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under ...
Surgical Devices·112,468 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Pro...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Pr...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
Maquet Inc.
Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support...
Medical Devices·63 affected·Nov 2, 2012
High RiskFDA
Biomet, Inc.
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are prima...
Medical Implants·4 affected·Nov 1, 2012
High RiskFDA
Biomet, Inc.
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to...
Medical Devices·36 affected·Nov 1, 2012
High RiskFDA
Ameridose Llc
All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be a...
Drugs·0 affected·Oct 31, 2012
High RiskFDA
Ameridose Llc
All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be acces...
Drugs·0 affected·Oct 31, 2012
High RiskFDA
Cooper Surgical, Inc.
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endos...
Surgical Devices·1,215 affected·Oct 31, 2012
High RiskFDA
B Braun Medical, Inc.
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary f...
Medical Devices·1,970 affected·Oct 31, 2012
High RiskFDA
Hill-rom, Inc.
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift System...
Medical Devices·3,816 affected·Oct 31, 2012
High RiskFDA
J T Posey Company
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for ...
Medical Devices·1,673 affected·Oct 31, 2012
High RiskFDA
Orthohelix Surgical Designs Inc
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Medical Devices·2,399,041 affected·Oct 30, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Digital Diagnost Stationary radiographic system
Diagnostic Devices·360 affected·Oct 30, 2012
High RiskFDA
Alara Pharmaceutical Co
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San...
Oral Drugs·7,432 affected·Oct 29, 2012
High RiskFDA
Schoep's Ice Cream Co, Inc
Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter P...
Dairy·4,140 affected·Oct 26, 2012
High RiskFDA
Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides w...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Hospira Inc.
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethern...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Red Chamber Company
Frozen Yellowfin Tuna Loin 3/5, 30lbs/case.
Seafood·750 affected·Oct 25, 2012
High RiskFDA
Hospira Inc.
Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Injectable Drugs·361,600 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to b...
Medical Devices·7,734 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASA...
Medical Devices·7,734 affected·Oct 25, 2012
High RiskFDA
Philips Healthcare Inc.
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital...
Diagnostic Devices·551 affected·Oct 25, 2012
High RiskFDA
Animas Corporation
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the tre...
Diabetes Devices·1,938 affected·Oct 25, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Medical Devices·476 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD ...
Medical Devices·7,734 affected·Oct 25, 2012
High RiskFDA
Carl Zeiss Meditec, Inc.
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation ther...
Medical Devices·36 affected·Oct 25, 2012
High RiskFDA
Dauphin Holdings, Inc. Dba Arnolds Candies
Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavorin...
Dairy·100 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along sutu...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography ...
Medical Devices·765 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Nidek Inc
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator ...
Medical Devices·21 affected·Oct 24, 2012
High RiskFDA
Sekisui Diagnostics Llc
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Typ...
Diagnostic Devices·63 affected·Oct 24, 2012