Samsung GU60A system-  Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - US (nationwide and Puerto Rico):     Units were also distributed globally to the following countries:  Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzegovina, Bulgaria, Canada, Chile, Columbia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Ecuador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Italy, Jamaica, Japan, Jordan, Kazakhstan, South Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, and Uzbekistan
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope.  LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries
Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope  base, which could contribute to a caster breaking or detaching from the base.
CADD(R) Medication Cassette Reservoir with clamp and female Luer.  Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
The medication cassette reservoir, part number  21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed  incorrectly.
US Nationwide Distribution in the states of KY, MD, NY, PA, VA
.  Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank.    product Usage:  Provides sterile environment to protect patient from infection
Burn Sheet has possibility of being shredded.
Burn Sheet:  Dukal Part # 7305, 30-01, CSM Part # R505-091.      First Aid Kit: CSM Part # K608-061 36M.      Burn pad lot numbers: JT36112, JT09113, JT17513.
Neusoft NeuViz 128 Multi-slice  CT Scanner System    Product  Usage:  The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
NeuViz 128 Multi-slice CT Scanner System with  software  version  1.0.7.4038+P16  or previous version
Neusoft Medical NeuViz  64  Multi-slice  CT  Scanner  System, including:  NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version,  NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version    Product Usage:  The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
NeuViz  64  Multi-slice  CT  Scanner  System, including:  NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version,  NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version
HEALTH WARRIOR CHIA BAR APPLE CINNAMON NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Cashews and Almonds)
Ingredient used in the manufacture of these products was recalled due to a potential for Listeria monocytogenes contamination.
HEALTH WARRIOR CHIA BAR VANILLA ALMOND NT WT 25 g (.88 g) ALLERGENS: Contains
HEALTH WARRIOR CHIA BAR COCONUT NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Almonds, Cashews, Coconut)
HEALTH WARRIOR CHIA BAR ACAI BERRY NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Cashews)
HEALTH WARRIOR CHIA BAR DARK CHOCOLATE NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Almonds, Cashews). Produced on equipment that also processes other tree nuts, peanuts, soy, wheat and milk.
ISS ONE Blueberry Cobbler Flavored Protein Bar  NET WT 2.12 oz (60 g) ALLERGY ALERT: This Contains Milk, Almonds and Soy (Lecithin), This Product is Manufactured in A Facility That Processes Peanut, Tree Nut and Wheat Ingredients
ISS ONE Salted Caramel Flavored Protein Bar  NET WT 2012 oz (60 g) ALLERGY ALERT: This Contains Milk, Almonds and Soy (Lecithin). This Product is Manufactured in A Facility That Processes Peanut, Tree Nut and Wheat Ingredients
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System  Model: DREX-UI80    Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.
The issue was identified as a firmware problem with the generator.
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert.   The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom
mcompass 2-channel Balloon Catheters    The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.
Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers:    a) ENF-Y50P-40  b) ENF-Y50P-50  c) ENF-Y60P-40  d) ENF-Y60P-50  e) ENF-Y60P-90  f) ENF-Y80P-40  g) ENF-Y80P-50  h) ENF-Y80P-80  i) ENF-Y80P-90  For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
Inadequate detectability of radiopaque stripes
a) ENF-Y50P-40, lot number KS1608011  b) ENF-Y50P-50, lot number KS1608012  c) ENF-Y60P-40, lot number KS1608013  d) ENF-Y60P-50, lot number KS1608014  e) ENF-Y60P-90, lot number KS1608015  f) ENF-Y80P-40, lot number KS1606035  g) ENF-Y80P-50, lot number KS1606036  h) ENF-Y80P-80, lot number KS1606037  i) ENF-Y80P-90, lot number KS1606038
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers:    a) ENF-50P-40  b) ENF-50P-50  c) ENF-50P-80  d) ENF-60P-40  e) ENF-60P-50  f) ENF-60P-80  g) ENF-80P-40  h) ENF-80P-50  i) ENF-80P-80  j) ENF-100P-110  For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
a) ENF-50P-40, lot number KS1606031  b) ENF-50P-50, lot number KS1606028  c) ENF-50P-80, lot number KS1608007  d) ENF-60P-40, lot number KS1608008  e) ENF-60P-50, lot number KS1606029  f) ENF-60P-80, lot number KS1608009  g) ENF-80P-40, lot number KS1606032  h) ENF-80P-50, lot number KS1606030  i) ENF-80P-80, lot number KS1606034  j) ENF-100P-110, lot number KS1608010
Worldwide Distribution - USA (nationwide) Distribution to the states of :  AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and  WV., and to the countries of  : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and  Switzerland.
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2.    The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm.    Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Defective container: Oral solution leaking from container.
Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806    Product Usage:  The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Caribena yellow maradol papaya packed in 35 pound cases
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only  The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Product was shipped to the following states: AL, AZ, CA, FL, IL, IN, MN, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT & WI.    Product was also shipped to Canada.
CORN TREATS CONCENTRATED CARAMEL CORN MIX NET WT 1 LB-6 OZ (22 OZ or 623 g) Manufactured by GOLD MEDAL PRODUCTS CO.
Missing ingredient statement on the label and undeclared soy.
Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
Blood product, mislabeled as crossmatch compatible, was distributed.
Amrita Sunflower Butter & Jelly  15g Protein Bar, 60gm  UPC: 853009004414
Product may be contaminated with Listeria monocytogenes
Best Buy date between 04/24/2018 to 05/31/2018
Amrita Dark Chocolate Quinoa 15g Protein Bar, 60gm  UPC: 853009004438
Amrita Chocolate Chip Coconut 15g Protein Bar, 60gm  UPC: 853009004391
Amrita Apricot Strawberry Protein Bar, 50gm   UPC :853009004056
Amrita Cranberry Raisin Energy Bar, 50gm   UPC: 853009004032
Amrita Mango Coconut Energy Bar, 50gm  UPC: 853009004018
Amrita Apple Cinnamon Energy Bar, 50gm  UPC: 853009004049
Amrita Chocolate Maca 15g Protein Bar, 60 gm  UPC: 853009004056
Amrita Pineapple Chia Energy Bar, 50gm  UPC: 853009004025
Papayas Maradol cavi, Grown and Packed by: CARICA DE CAMPECHE, DISTRIBUTED BY: AGROSONS LLC
Product may be contaminated with Salmonella.
Worldwide Distribution - US Distribution to the states of : MI, IL and TX.,  and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia,  Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel
Rigid Arm Supports (PN:  106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
Valery Brand Maradol Papayas sold fresh in 35 pound boxes. Labeled grown and packed by Carica de Campeche
The recalling firm received papayas from a Mexican grower associated with an outbreak of Salmonella.
All Valery Brand Maradol papayas distributed from July 10 to July 13, 2017.
Artis zee/zeego and Artis Q/Q.zen system,  x-ray, angiographic  AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet.  Loss of coolant can results in a cooling system failure and subsequent system failure.  This leek can occur sporadically in affected systems.
Artis zee biplane MN- Serial number: 149402  149401
Artis zee floor MN - Serial number: 140221  140226  140406
To distributors in NC, CA, NY, IA, PA, CT, TX, NJ, KS, KY. IL:. CO 7 Distributors at multiple addresses.
Mary's Gone Crackers Original Crackers:  Organic, Gluten Free, Non-GMO, Vegan.  6.5 oz. (184 g) box;    Ingredients: Whole grain brown rice, whole grain quinoa, brown flax seeds, brown sesame seeds, filtered water, sea salt, wheat free tamari (water, whole soybeans, salt, vinegar).  Contains: Soy.    Unit UPC: 8 97580 00010 6;  Case UPC: 8 97580 00030 4;
1,988 cases (12 x 6.5 oz. boxe per case).
Recall of crackers due to pieces of blue grade plastic liner found inside the packaged cracker product.
The product was distributed thru out the United States.  The firm took orders for the product via internet.
Bourbon Street Mix, 157 25 lbs cases and 2,509 one (1) lb bags.
According to the firm ( Nuts.com) undeclared cashews were in the Bourbon Street Mix.   The firm learned of the problem through a customer complaint. The firm is doing a recall of the product due to undeclared allergens.
Product was distributed to retail grocery stores in Missouri, Illinois, and Indiana.
German chocolate cakes labeled as Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow, Net Wt. 1 lb 1 oz (482 g), UPC 0 41218 31168 6
German Chocolate cakes were labeled as Chocolate Iced Yellow Cake.  German Chocolate contains pecans that are not listed on the Iced Yellow Cake label.
Best by date between 8/12/17 through 8/14/17
The product has been recalled due to the potential to be contaminated with Listeria monocytogenes.
CARLA'S PASTA, INC. BASIL PESTO SAUCE: BULK, Mfd. Date 06/20/17, KEEP FROZEN NET WT. 13.40 LBS (6.08 kg) 00021605014209
Product may be contaminated with Listeria monocytogenes.
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers:    REF S-200956 - 5mm PIN, SIZE 46   REF S-200957 - 5mm PIN, SIZE 50  REF S-200958 - 5mm PIN, SIZE 58
It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ  07054, NDC 60432-065-00.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars   1.76 oz (50g)  Outer Box: UPC:  60265220102-8
26,328 consumer units (outer carton boxes)
Mislabeled Outer Box labeled as : KIND Breakfast Dark Chocolate Cocoa Bars  may contain KIND Breakfast PROTEIN Dark Chocolate Cocoa Bars.
Best Before Date of 03/05/2018 and only   Lot Code BK17156A2 (Outer Box)
(a) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 12oz. pouch,   UPC: 8-56088-00315-6    (b) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 2oz. cup  UPC:  8-56088-00311-8
Product labeled containing pecans actually contains almonds
a)LOT CODES: JUNE 29,2018 & AUGUST 11,2018  (b) LOT CODES: AUGUST 11, 2018
Dude Products Facial Wipe, 3 in 1, 30 count per pack
Firm received complaints of mold on Dude Products Facial Wipe
Distributed throughout the United States
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
American National Red Cross (The), Lewis and Clark Region
Blood product, for which unit sterility was compromised during collection, was distributed.
Mayo Clinic Rochester Division of Transfusion Medicine
Blood and Blood Products for Reprocessing
Blood products, collected from an ineligible donor, were distributed.