Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for  volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
List Number: 02507; Serial Numbers: All.
There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.
Plum XL,  Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
List Number: 11555; Serial Numbers: All.  List Number: 11855; Serial Numbers: All.   List Number: 11859; Serial Numbers: All.
List Number 11555: 17,887 pumps; List Number 11855: 1,292 pumps; List Number 11859: 147,399 pumps
Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System.  Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
List Number: 11781; Serial Numbers: All.  List Number: 11845; Serial Numbers: All.   List Number: 11846; Serial Numbers: All.
List Number 11781: 1,828 pumps; List Number 11845: 13,700 pumps; List Number 11846: 22,671 pumps
Nationwide, Italy and Republic of South Korea
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977.  MADE IN INDIA.  NDC 59762-5030-1
Defective Container: Tamper evident ring failures discovered on some bottles.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
USA nationwide, Singapore, Ireland, Canada, Czech Republic, Saipan, Panama, Norway, and Nigeria.
KISS MY Face Grapefruit & Bergamot Foaming Soap: 1) Net Wt. 8.75 Fl Oz (258 mL), UPC 0 28367 83309 3; 2) Net Wt. 17.5 Fl Oz (516 mL), UPC 0 28367 83479 3.  Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.
Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination.
KISS MY Face Lemon & Ginger Foaming Soap: 1) Net Wt. 8.75 Fl Oz (258 mL) - UPC 0 28367 83473 1, 2) Net Wt. 17.5 Fl Oz (516 mL) - UPC 028367 834779.  Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.
KISS MY Face Lavender & Chamomile Foaming Soap: 1) Net Wt. 8.75 Fl Oz, UPC 0 28367 83308 6; 2) Net Wt. 17.5 Fl Oz (516 mL), 028367 834786.  Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.
KISS MY Face obsessively natural KIDS Self-Foaming Hand Wash, orange U smart, Net Wt. 8 Fl Oz (236 mL), UPC 0 28367 83591 2. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Worldwide Distribution -  US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
ExacTrac software version 5.5.5 is included in the following model / catalog numbers:    1) 20818B ET SOFTWARE 5.5.5;   2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5;   3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5;   4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5;   5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5;   6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5;   7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5;   8) 49660A ET INFRARED SOFTWARE 5.5.5;   9) 49961 ET DATA PREP/REVIEW SYSTEM;   10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT;   11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT;   12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT;   13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT;   14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT;   15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.
Siemens SOMATOM Emotion 16 and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
Blood product, with a low platelet concentration, was distributed.
US Distribution including the states of FL, NJ and MN.
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device.   For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
SBi RingFix Olive Wires   Product Usage:  These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside.
Nationwide and Foreign distribution to South Korea and England
True Liquid Hand Soap, 15 oz container. Redwood Fragrance
Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.
True Liquid Hand Soap, 15 oz container. Marine Fragrance
True Liquid Hand Soap, 15 oz container. Chamomile Lavender Fragrance
True Liquid Hand Soap, 15 oz container. Gardenia Fragrance
True Liquid Hand Soap, 15 oz container. Champagne Fragrance
True Liquid Hand Soap, 15 oz container. Feu de Bois Fragrance
True Liquid Hand Soap, 15 oz container. Fleurs de Baies Fragrance
True Liquid Hand Soap, 15 oz container. Apricot Fragrance
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL  60045 USP, NDC 0409-1559-10.
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, labeled as leukoreduced were not tested to verify the White Blood Cell count, was distributed
Oklahoma Blood Institute - Sylvan N Goldman Center
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor with no arm inspection, were distributed.
Nationwide Distribution including AZ, CA, FL, and NY.
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant.  For in vitro diagnostic use.
Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.
Worldwide Distribution - USA (nationwide) and Canada.
Arrow Percutaneous Sheath Introducer Kits   The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
Worldwide Distribution -  US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03
Product does not function as intended up to the expiry date on the product labeling.  There is a link between the age of the product and staining intensity.
US Distribution including the states of  PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System    The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Class II Recall - US Distribution including the states of  IL,VA, TN, PA, TX, MN, GA, MI, IN, OH, FL, CA, OR, NY, ME, MO, OK, CO and NJ.
AXIOM Luminos dRFsystem    The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.
AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MO, MS, NC ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA WI, WY, and Hawaii  Foreign: Ireland, Barbados
Greens+ Vegan Crisp Bars - Dark Chocolate Almond Blueberry in 1.4 oz packages.
Undeclared milk protein in chocolate coating.
Greens+ Vegan Crisp Bars - Dark Chocolate Peanut Butter in 1.4 oz packages.
Greens+ Vegan Crisp Bars - Dark Chocolate Almond Coffee Crisp in 1.4 oz packages.
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS,   NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM
Composix'' LP with Echo PS'' 10x13 HUXH0294 HUXL0314    Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Composix'' LP with Echo PS'' 6x10 Reorder Number:  0144610   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Composix'' LP with Echo PS'' 6x8 Reorder Number:  0144680   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Bard Composix'' LIP Mesh with Echo PS'' 7''x9'' Reorder Number:  0144790   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Bard Composix'' LIP Mesh with Echo PS'' 8''x10'' Reorder Number:  0144810   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
BardVentralight'' ST Mesh with Echo PS'' 10''x13'' Reorder Number:  5955113   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Lot Number:  HUXK0900, HUXK0901, HUXL1148
Bard Ventralight'' ST Mesh with Echo PS'' 12''x14''  Reorder Number:  5955124   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Bard Ventralight'' ST Mesh with Echo PS'' 4.5'' Circle Reorder Number:  5955450   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Lot Number:  HUXH0535, HUXH0696, HUXK0747
Bard Ventralight'' ST Mesh with Echo PS'' 4''x6'' Reorder Number:  5955460   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Bard Ventralight'' ST Mesh with Echo PS'' 6'' CircleReorder Number:  5955600   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Lot Number:  HUXH0694, HUXL1149, HUXL1150, HUYA1005
Bard Ventralight'' ST Mesh with Echo PS'' 6''x10'' Reorder Number:  5955610   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Bard Ventralight'' ST Mesh with Echo PS'' 6''x8'' Reorder Number:  5955680   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Lot Number: HUXH0688, HUXK0743, HUXL0803, HUXL0804
Bard Ventralight'' ST Mesh with Echo PS TM 7''x9''  Reorder Number:  5955790   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Bard Ventralight'' ST Mesh with Echo PS'' 8'' Circle Number:  5955800   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Bard Ventralight'' ST Mesh with Echo PS'' 8''x10'' Reorder Number:  5955810   Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Lot Number: HUXH0691, HUXL0336, HUXL0495, HUXL0660, HUXL1006, HUXL1007, HUXL 1147
Distributed Nationwide including Puerto Rico and the states of AL, AK,AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM , NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.
BG3515-5 US 5mL BioGlue Surgical Adhesive.    BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Monoswift  PGCL [poly (glycolide-co-caprolactone)]  Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936.  Product is labeled sterile.  The product is sealed inside an inner foil pouch with an outside Tyvek pouch.  It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle
US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total).
CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.
Worldwide Distribution - USA including Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, South Dakota and Internationally to Australia, Austria, Belgium, Chile, Finland, Germany, Great Britain, Greece, Israel, Italy and Russia.
Integra Licox Test Kit REF BC10R Rx Only    An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.
Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous ''calibration test failure'' message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).
The products were sold to wholesale distributors in the following states: Alabama, Arizona, California, Texas, Washington, Nevada, New York,  Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts, and Ohio.   Wordwide to Canada.
CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA CAPSULES  CAPTAIN KRATOM PREMIUM THAI POWDER 15 Grams  CAPTAIN KRATOM PREMIUM BALI CAPSULES 15 Grams  CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 15 GRAMS  CAPTAIN KRATOM PREMIUM THAI LEAF 15 Grams  CAPTAIN KRATOM 30 grams Thai Capsules XL  CAPTAIN KRATOM PREMIUM THAI CAPSULES 8 Grams MINI  CAPTAIN KRATOM PREMIUM THAI RESIN 6 Grams  CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 30 GRAMS
Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals and Kratom Pro products because they may be contain Kratom (mitragyna speciosa).
Arena Ethnobotanicals and Kratom Pro, sizes: 1oz, 4oz, and 8oz.
Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA,  NDC 57613-003-18
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA,  NDC 57613-013-15.
E & M Corporation, Dba Noh Foods International Of Hawaii
US distribution - HI, CA, FL, VA, ID, UT, NV, IL OR, WI, WA. Also Australia, French Polynesia.  Mail order sales to FL, CA, MI, NM, WA, NY, NJ, TN, OR, MN, IA, ID and Canada.
Hawaiian Coconut Pudding, Haupia Luau Dessert; Packaged in Net Wt. 2  oz. (57 g); Net wt. 4 oz. (114 g) and Net wt. 48 oz. (3 lb) 1.36 kg.  Ingredients: Sugar, coconut ''powder, corn starch, locust bean gum, carrageenan, maltodextrin.  2 oz UPC 073562000504;  4 oz UPC 073562000559;  3 lb UPC 073562000511,    NOH Foods of Hawaii, Honolulu, HI
Consumer complaint initiated testing of the product by University of Nebraska who found >5000 ppm of milk allergen.
Worldwide distribution, including US nationwide, Argentina, Australia, Austria, Canada, Cayman Islands, Chile, Denmark, Finland, France, Germany, India, Iraq, Israel, Italy, Latvia, Malaysia, Mexico, Netherlands, Panama, Peru, Poland, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Turkey and United Kingdom.
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal.  In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.
Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.
MACROLYTE Premie Dispersive Electrode, REF 440-2400,  CONMED CORPORATION.  The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where  s is the shift).
Domestic - 12,600 units, Foreign - 44,280 units
ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection.  The complaints have been confirmed by ConMed.
Worldwide Distribution - US Nationwide,  ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, VENEZUELA, VIETNAM, and YEMEN.
Kenex Radiation Shield and surgical lamps  installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.   Kenex Suspension installed with Radiation shield and lamp with following model numbers:  E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC.    Product Usage:  Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.
GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Sales to retail stores are located in MI, MN, IL, ID, MT, NC, GA, PA, OK, TX, KY, MA, FL, and NY.  The one wholesale customer is in MI.
American Spoon Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tart Cherries, , Sugar, Lemon Juice, Pectin. ALLERGY INFORMATION: Manufactured in a facility that also processes soybeans, milk, eggs, fish, and tree nuts. Refrigerate after opening American Spoon Foods PETOSKEY, MICHIGAN 49770 800 222 5886 UPC 0 19363 01010 6
code 3322 The code is a 12 digit code printed on the side of the jar as: 3322000*** and with a Best Flavor by date of 11/2016.  The missing digits include the sequential batch number for the day and a sequential jar number for each jar in the batch.
American Spoon, Sour Cherry Preserves, 9.5 oz (UPC 019363010106) may contain mold.
REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82001 9
The nutritional panel on the packaging incorrectly states the sodium content as 35g, when it should read 35mg.
REDVINES FRUIT VINES Bites Strawberry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82006 4
Lily Bloom's Kitchen Chocolate Coconut Poparoons
Poparoons do not contain a lot number or code
Lily Bloom's Kitchen Poparoon flavors that contain milk which was not listed on the label include lemon, key lime, strawberry, blueberry and chocolate dipped in a white chocolate coating.
Raclette du Haut Livradois  Ste Fromagere du Livradois 63980 Fournols  13lbs or cut and wrapped (weight may vary)  wrap in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated
Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Montboissie du haut- Livradois  Manufactured by Ste Fromagere du Livradois 63980  Fournols  13lbs or cut and wrapped (weight may vary)  wrapped in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated
Worldwide distribution.  US Nationwide including PR and DC, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Cape Verde, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Herzegovina, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, LAO People's Dem, Rep., Latvia, Lebanon, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nahar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam and Yemen.
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
A customer reported that the table top had become free floating.  A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
Stryker Instruments Div. of Stryker Corporation
Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing.  This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.
The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints
The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest ---   Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.
enGen (TM) Laboratory Automation Systems Configured with enGen (TM) Select or Custom (TM) v3.2.2 and below with Data Innovations, LLC Instrument Manager (TM) v8.06 with Data Innovations, LLC TCA Driver v8.04.0020 and below
Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.
Worldwide Distribution -- USA, including the states of AK, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WY and the territory of Puerto Rico; and, the countries of Brazil, Canada, Chile, Colombia, Cuba, Honduras, and Mexico.
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
Potential for patient to be marked incorrectly.  Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)
Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6;  SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL
New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).
Retail locations in MN,OH, KY, NY, CO, WA, CA, MO, IN, MI
Dragonfly Brand Crushed Chili Powder, Net Wt.  6.3 oz plastic tubs. Product of Thailand  UPC 7 21557-53317 8    Packed for:  U.S. Trading Co., 21118 Cabot Blvd., Hayward, CA  94545
44 cartons (48 x 6.3 0z tubs per carton)
IEH sample of Crushed Chili Powder collected at retail was positive for Salmonella Ba reilly.
Worldwide Distribution - USA (nationwide) including the countries of  Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
Medrad Continuum MR Infusion system- non-wireless system   The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.
Medtronic Model 8780 Ascenda Intrathecal Catheter.   The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039.   The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
Hologic M-IV Mammography System; Model M4--00001.   Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Gavina Northwest Blend Dark Whole Bean Bag Net Wt. 5lb,    Product label reads in part ''***085895***DECAF EUROPEAN BLEND 5LBS WHOLEBEAN BAG***''
F. Gavina and Sons Inc. is recalling Gavina Northwest Blend Dark whole beans because it was mislabeled as decaffeinated product.
US. No International.   US States: CA, HI, MO, FL, MN, MS, MN, NC, NE.
Rockman (Brand) Raw Peanuts with Red Skin, 12 oz.   Packaged in plastic pouch. 12oz/60bags/carton.    Labeled as ''PEANUT'' on packaging.    Product labeling reads in part: ''ROCKMAN***PEANUT N.W.: 12 OZ (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF CHINA***DISTRIBUTED BY: ROCKMAN COMPANY (USA) INC.***COMMERCE, CA***PRODUCT OF CHINA***''.
Rockman Company USA, Inc. inititated the recall of raw peanuts due to mold and mis-labeling: missing Allergen Statement, missing Nutrition Facts Information, missing List of Ingredients, and inaccurate Distributor address and phone number.
Rockman (Brand) Skinless Peanut, 12 oz.   Description: blanched skinless peanut.    Packaged in plastic pouch. 12oz/60bags/carton.    Product labeling reads in part: ''ROCKMAN***SKINLESS PEANUT 12 0Z (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF CHINA***DISTRIBUTED BY: ROCKMAN COMPANY (U.S.A.) INC.***COMMERCE, CA***PRODUCT OF CHINA***''.
Rockman Company USA, Inc. inititated the recall of raw peanuts due to mold and mis-labeling and blanched peanuts due to mis-labeling.
Distributed to one foreign consignee in Lebanon.
Wound Drain - Label reads in part ''Elutia ***Hubless Coated Silicone Surgical Wound Drain***'' Two different sizes, 10 units per box:  19 Fr Round Hubless part number 7110;   24 Fr Round Hubless part number 7118.    AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products.  All of the affected products were appropriately sterilized
Sterile Cord Blood Collection Unit, Anticoagulant Citrate Phosphate Dextrose Solution (CPD), Code 791-08 (PALL Medical label) and 791-09V (ViaCord label),  UPC code for Pall product code: 791-08: (Case box): (01) 30636207307966 There is no UPC code issued to the ViaCord product. --- The systems are packaged STERILE within a ''sterilization pouch'' (1 system/pouch) and placed within a foil envelope (1 pouch/ envelope).  There are 24 units packaged per case box.
Pall Sterile Cord Blood Collection System Code 791-08: Lot number 1356443 (Expiry Date 10/2016); ViaCord's Sterile Cord Blood Collection System, Code 791-09V: Lot numbers 1356441 and 1356442 (Expiry Date 10/2016)
Sterile Cord Blood Collection Systems, with a limited number of reports of a blood leaks, were distributed.
Siemens Ysio Systems    Product Usage:  The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.
Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
PATH THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc.  Orthopaedic surgical instrument.
Difficulty removing the cup adaptor from the impaction handle during surgery
The product was distributed to one customer in MI, and internationally (Taiwan)
115 V Blanketrol II, Model 222S Hyper-Hypothermia System .  Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but no alarms will alert the user of the loss of therapy condition.
Spacelabs Medical Ultraview SL'' Command Module, Model 91496.    Detector and alarm, arrhythmia. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000.  The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.
Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
Bread was distributed to 16 retail makets in Oregon and 1 retail market in Washington.
KrustaVita Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag.  UPC: 8 5243000200 6.
Royal Rye LLC is recalling their KrustaVita Bread of Life rye bread due to undeclared soy.
Nationwide Distribution including CA and IN
Toshiba Infinix X-Ray Interventional System  INFX-8000V/UU.  An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been found that although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, and does not stop.