Worldwide Distribution - USA (nationwide)  Distribution including Puerto Rico and the states of  AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.
The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system performance issues.
Worldwide Distribution-USA (nationwide) and the countries of  Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5'' x 96'', REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS  39702.
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5'' x 96'', REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS  39702
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5'' x 96'', REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS  39702
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5'' x 98'', (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS  39702
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS  39702
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
US Distribution including the states of  CT, FL, IL, NJ, NY, PA, TN, VA and WI.
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician.   Probe cover
No endotoxin (LAL) testing to proper level.
Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle).
unknown (firm did not maintain accurrate consistent logs)
Mira Health Products Ltd. recalled products marked as Dietary Supplements due to the use of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract in their raw materials.
Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK
enGen Track System with enGen Select v5.0 with autoverification enabled   Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
Autoverification and Custom Rules for enGen Laboratory Automation Systems using enGenTM Select v5.0
Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
enGen Track System with enGen Custom v3.2.2 (& below)   Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
Custom v3.2.2 & Below Configuration Files
Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems   Product Usage:  Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.
1) VITROS 250 (Product Code 8132086; Model # 3332); 2) VITROS 350 (Product Code 6802153; Model # 3330); 3) Mixing Cup Arrays (Product Code 1631779; Model # n/a)
6380 units (each unit contains 48 arrays with 10 microcups)
Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250  and VITROS 350 Chemistry Systems.  Increase in Software error due to affected Mixing Cup Arrays.
Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette.   United States; Bio-Rad Laboratories,  Hercules, CA 94547    The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
2906 kits (318 Kits in US; 2588 kits internationally)
D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
Distributed USA (nationwide) and the country of Canada.
Normative Data Template CD for use with the I-Portal devices.   Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC.  Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates.
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.
Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient's body, potentially leading to infection and serious injury.
Worldwide  Distribution and USA Nationwide.
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product  Usage:  The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
Nationwide;  GERMANY, AUSTRIA, CANADA, NOVIA SCOTAIA, COLOMBIA, LEBANON, GREECE, PERU, RUSSIA, INDIA, MEXICO, JAPAN, ARGENTIAN, IRELAND, ICE.A D ITALY, NUMBAI, TURKEY, THAILAND, UNITEDKINGDOM, SINGAPORE, FRANCE, BOLIVIA, ESTONIA, ISRAEL, NEW ZEALND, SPAIN, PAKISTAN, INDONESIA, ROMANIA, CHINA, TAIWAN, VIETNAM.
AllSet+'' Gold HLA-A Low Res SSP, 54310D; UniTray A Locus SSP, 7860010; UniTray A Locus SSP w/ Taq, 7860110; AllSet+'' Gold HLA-ABC Low Res SSP,   54340D; UniTray ABC SSP, 7800010; UniTray ABC SSP w/ Taq, 7800110;  AllSet+'' Gold HLA-AB/DR Low Res SSP, 54350D; UniTray AB/DR SSP, 810010; UniTray AB/DR SSP w/ Taq, 7810110;   AllSet+'' Gold HLA-AB/DR/DQ Low Res SSP, 54360D;  UniTray AB/DR/DQ SSP, 7850010;  UniTray AB/DR/DQ SSP w/ Taq  7850110.
HLA typing assay, associated with false negative results, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Nationwide; CANADA, NS, COLOMBIA, MUMBAI, SINGAPORE, ARGENTINA, BOLIVIA, ISRAEL, NEW ZEALAND, PAKISTAN, INDONESIA, QATAR, JAPAN, VIETNAM, CHINA, TAIWAN, YEMEN, INDIA, LEBANON,  EGYPT.
Invitrogen by Life Technologies:   54350D ALLSET GOLD HLA ABDR LOW RES, 54360D ALLSET GOLD HLA ABDRDQ LOW RES, 54370D ALLSET GOLD HLA DR LOW RES SSP,   54380D ALLSET GOLD HLA DRDQ LOW RES,7810010 AB/DR SSP UNITRAY 10 TESTS, 7810110 AB/DR SSP UNITRAY W/TAQ 10 TS,   7820010 DR 4T SSP UNITRAY 40 TESTS,7840010 DR/DQ 2T SSP UNITRAY 20 TESTS,7840110 DR/DQ 2T SSP UNITRAY W/TAQ 20T.                         7850010 AB/DR/DQ SSP UNITRAY 10 TESTS  7850110 AB/DR/DQ SSP UNITRAY W/TAQ 10T
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed.
Nationwide;  NETHERLANDS, GREECE, RUSSIA, INDIA, SOUTH AFRICA, FRANCE, GERMANY, ITALY, TURKEY, UNITED KINGDOM, DUBAI, IRELAND, SWITZERLAND, NEW ZEALAND, SWEDEN, SPAIN, INDONESIA, SAUDI ARABIA, JAPAN, URUGUAY, CHINA, TAIWAN.
Invitrogen by Life Technologies:    DRB1-15 SSP UniTray Kit, 450102D; DRB1-15 SSP UniTray Kit with Taq Polymerase, 450112D; AllSet+'' Gold SSP HLA DRB1-15/16 High Res Kit, 54290D.
Blood Centers of the Pacific - Irwin Center
Red Blood Cells Deglycerolized Leukocytes Reduced
Blood product, failed to meet the minimum specification for percent red blood cell recovery, was distributed.
Inova Health Care Services, Inova Blood Donor Services
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
US: Nationwide (AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY,LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV); FOREIGN: Austria, Belgium, Canada, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom
OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain
*** US PRODUCTS *** 1) 6 mL Vials. List Number 04943-04-01. Lot Codes and Expiration Dates: EMFG, 11/2014; FBDN, 02/2015; FEBU-3, 05/2015, FEBU-1, 05/2015. 2) 11 mL Vials. List Number 04943-04-02. Lot Codes and Expiration Dates: EMFF, 11/2014; FEBU-2, 05/2015. 3) 13 mL Vials. List Number 04943-04-03. Lot Codes and Expiration Dates: EMFG-1, 11/2014; EMGL, 11/2014; EMGM, 11/2014, EMGN, 11/2014.    *** FOREIGN PRODUCTS *** 4) 6 mL Vials. List Number 04943-90-01. Lot Codes and Expiration Dates: EDEG-2, 05-2014; EKFE, 9-2014. 5) 6 mL Vials. List Number 04943-27-01. Lot Codes and Expiration Dates: EDEG, 05-2014. 6) 6 mL Vials. List Number 04943-03-01. Lot Codes and Expiration Dates: 33008XN, 10-2015.; 33004XN, 10-2015. 7) 11 mL vials. List Number 04943-90-02. Lot Codes and Expiration Dates: EDEG-3, 05 -2014; EFKE-1, 09-2014. 8) 11 mL Vials. List Number 04943-27-02. Lot Codes and Expiration Dates: EDGE-1, 05-2014. 9) 33 mL Vials. List Number 04943-27-03. Lot Codes and Expiration Dates: EDEH, 05-2014; EDEF, 04-2014; EHGM, 08-2014. 10) 33 mL Vials. List Number 04943-90-03. Lot Codes and Expiration Dates: EFFW, 06-2014; EHEK, 09-2014.
*** US PRODUCTS *** 6 mL Vials: 14,527 vials. 11 mL Vials: 14,104 vials. 33 mL Vials: 13,306 vials.
Some particles were observed in a limited number of OroCAM units. The particles if present could clog the pump mechanism and could also potentially result in under-administration.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide. No foreign.  Includes military/govt/VA consignees.
BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Products were recalled due to possible Listeria monocytogenes contamination.
Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC  NM XHot 12-13 oz Z, Product Item Number 1021-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 28 oz each per case totaling 10.5 lbs.
Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 28 oz each per case totaling 10.5 lbs.
Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 56 oz each per case totaling 21 lbs.
Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 56 oz each per case totaling 21 lbs.
Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 56 oz each per case totaling 21 lbs.
GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM  Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM  Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags.
Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags.
Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed.
Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package  Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA  Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France  Made in USA  non-sterile
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation.  ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.
RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
Watson Laboratories, Inc.-(Actavis) - Florida
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
Failed Stability Testing: This product is below specification for preservative content.
Product trade name  t:slim'' Insulin Delivery System  Generic name  Insulin Infusion Pump       510(k) Number K111210 cleared on Nov. 9, 2011    Description of the product - The Tandem t:slim'' Insulin Delivery System (t:slim System or t:slim) is an Insulin Infusion Pump, product code LZG, per 21 CFR 880.5725.  The t:slim System consists of the following components and accessories: (1) a software-controlled, programmable insulin infusion pump (t:slim Pump) capable of both basal and bolus delivery of insulin; (2) a dedicated, disposable 3mL (300 unit) insulin cartridge; (3) UnoMedicals Comfort'' Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a Becton Dickinson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pumps internal battery, cartridge Instructions for Use, and Users Guide.
Tandem Diabetes Care, Inc. announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump.  The affected cartridges may be at risk for leaking.  The cause of the recall was identified during Tandems internal product testing, and has not been associated with any complaints or adverse events reported by customers.  However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN  38132   Orthopaedic - filler, bone void
Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
nationwide to various retail stores and internet companies
PASKESZ PREMIUM BELGIAN CHOCOLATE, KOSHER PARVE, Holographic Coins, Net Wt. 0.5 oz (14g)  packaged in  a carton containing 12 boxes with each box containing 24 mesh bags x 0.5 oz (14g) total weight 12 oz (336g), each mesh bag contains 5 pieces, ITEM 30178.  MADE IN HOLLAND FOR: PASKESZ CANDY CO., Inc. Brooklyn, NY 11232.
2,334 Total cases (not including 1,472 cases and 6 boxes in stock, quarantined)
Paskesz Candy Co., Inc. has recalled PREMIUM BELGIAN CHOCOLATE coins due to Undeclared Milk.
Kinnikinnick Gluten Free Bread Crumbs Panko Style - gluten free, dairy free, nut free. 350g/12.5oz.  UPC 62013360015 3 2
20140111, 2014AL20, and 2014JL23.  The last two lot codes were part of the first expanded recall.   Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December, 2013.  The 1/23/14 announcment states Up to and including Best Before 2014AU09, 20140809, and 140809.
Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk.  The labels also have a logo on them which indicate the product is dairy free.
Kinnikinnick Gluten Free Pancake and Waffle Mix, gluten free, dairy free, nut free. 454 g/ 16 oz  UPC 62013300512 2
20140502, and 20140417.   Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013.  The 1/23/14 notice states up to and including Best Before 2015JA06, 20150106, and 150106.
Kinnikinnick Gluten Free Original Homestyle Waffles Frozen  Contains a logos on the package indicating it is gluten free, dairy free, and nut free.   210 g/7.4oz Qty/pkg - 6.  UPC 62013300198 1.
2014AL15, 2014JN24, 2014MA07, and 2014JL29.   Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013.  The new notification states Up to and including Best Before 2014AU10, 20140810, and 140810..
Kinnikinnick Gluten Free Cinnamon and Brown Sugar Homestyle Waffles - Frozen - gluten free, dairy free, nut free. 210 g/7.4oz Qty/pkg - 6  UPC 62013300199 8
2014AL15, 2014JN25, and 2014JL14.   Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013.  The expanded recall notice dated 1/23/14 states up to and including 2014AU11, 20140811 and 140811.
Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI.   Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop).  An E-Stop will interrupt a current scan, resulting in an incomplete study.
The product is distributed in KS and MO only to local grocery stores.
Farm To Market Bread Co. San Francisco Sourdough, net weight 1 lb., unbleached enriched flour, water, sea salt, vitamin C.  Farm to Market Bread Co., Kansas City, MO.
The product label does not list wheat flour as an ingredient.  Undeclared allergen.
Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110.    510(k):  91-2109  K061342.  91-2110  K051942.         The Malibu'' System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.
Model Number(s):      91-2109 (8.0 Plus)       91-2110 (Standard).    Lot AL549784F:  91-2109 Malibu Polyaxial Screwdriver 8.0 Plus.  Lot AL552404F:  91-2110 Malibu Polyaxial Screwdriver Standard.  Lot AL546768F:  91-2110 Malibu Polyaxial Screwdriver Standard.    The devices are not distributed as sterile and do not have a expiration date.
Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient  injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided  in the kit was retrieved and used.
Panko Style Bread Crumbs, 12.5 oz, UPC 620133600153, NB Item #636886
Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.
Pancake and Waffle Mix, 16 oz, UPC 620133105122, NB Item#645556
Original Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001981, NB Item #616953
Cinnamon and Brown Sugar Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001998, NB Item #616961.
Gourmet Bar in the following flavors: bacon, cayenne pepper, crispy orange, curry, mendiant dark, mendiant light Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com
2264 units wholesale (total for all products), plus internet sales
Product may contain undeclared allergens
Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread, peppermint, red velvet, vanilla Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com
Dry fruits covered in chocolate in the following flavors: orange peel, mango cayenne, pear Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com
Chocolate Gift Boxes: SC 6 Oreos, SC Small 12 Chocolate, SC Small 6 chocolate Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com
Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com
U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
Horizon Medical Imaging, Picture Archive Communication System (PACS).
Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
Distributors in California, Indiana, Iowa, Michigan, Missouri, Pennsylvania, and Tennessee with further distribution to retail stores nationwide.
Pringles, the Original, Net Weight 5.68 oz (161 g) UPC code  0 38000 84496 6                                                       Ingredients: INGREDIENTS:  DRIED POTATOES, VEGETABLE OIL (CONTAINS ONE OR MORE OF THE FOLLOWING: CORN OIL, COTTONSEED OIL, SOYBEAN OIL, AND/OR SUNFLOWER OIL), CORN FLOUR, WHEAT STARCH, MALTODEXTRIN, SALT, RICE FLOUR AND DEXTROSE.  CONTAINS WHEAT INGREDIENTS    Product was placed in 226 display shippers with a variety of Pringles products.  PRINGLES US 4-FLV 84ct ALT SHPR UPC 38000 84832  PRINGLES US 3FLV MXD 728/164G PALLET UPC 38000 84620
individual cans codeL 3269KT70 0830 - L 3269KT70 0930 BEST BY 12/26/2014    Manufacturing Code on Shippers  PRINGLES US 4-FLV 84ct ALT SHPR  KT 12064C and KT12074A    PRINGLES US 3FLV MXD 728/164G PALLET  KT 12264
~ 75 affected cans w/in the ~ 4,760  produced w/in time frame
Panko Style Bread Crumbs net wt. 350g 12.5 oz. gluten free, dairy free, nut free
Up to and including Best Before 2014AU09, 20140809, 140809
Gorgonzola Gems Jalapeno Peppers With Gorgonzola and Cream Cheese Blend 8 oz. (227 g) packages, 6/pack
Lot #'s 1024020A and 1023020B (Products also contain a BEST BEFORE NOV 15 14 code, and UPC code 2113010895)
product has the potential to be contaminated with Listeria monocytogenes
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2)  5444-01-102 Host Bone; Howmedica Osteonics Corp.  325 Corporate Drive, Mahwah, NJ 07430 USA.    Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920 Martigny, Switzerland.
Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets)
Gano Excel USA is recalling the C'Real Spirulina because it contains undeclared wheat and soy.
One lot of Standardized Bermuda Grass Pollen Allergenic Extract, with a decreased potency, was distributed.
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI....
Failed Tablet Specifications: Broken Tablets Present.
US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX.   OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.
Boston Scientific, 2.5mm Coyote'' OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN#  H74939186251210, Catalog # 39186-25121.
Boston Scientific is initiating this Recall Removal of one lot of the Coyote'' OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote'' MONORAIL'' PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention.
Boston Scientific, Coyote'' MONORAIL'' PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.