Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Castile Soap Towelette (SKU T-3112-1S and SKU T-30120-1S
Product is contaminated with Nesterenkonia lacusekhoensis.
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea,  & Belgium.
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after)  Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
25 devices (4 domestically in U.S.A. and 21 internationally)
Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
and the same message  window appeared. This sam
Covidien Dover  PRECISION PRM 16FR SIL COUDE CATH SECURE  Item Code: PP16CSD  Castile soap towelettes are used to clean the genital area for male and female patients
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Covidien Dover  PREC PRM 18FR SILVER FLY TY  Item Code: PP18XSD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  P400 PREM U/M 18FR SIL FLY     Item Code: P4P18SD   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP   Item Code:  24035  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  P400 PREM U/M 18FR SIL COUDE CATH SECURE   Item Code: P4P18CSD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  PREM U/M 14FR TMP SNS CSD  Item Code:  P4P14TSD P400   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL   Item Code:  24015  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  P400 PREM UM 16FR SILV TMP CSD   Item Code: P4P16XTSD   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover   P400 UM 18FR SIL COUDE SECURE   Item Code: P4P18CSDK  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover P400 PREM U/M 18FR UL FOLY CSD   Item Code:  P4P18ULD   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover   PREC PRM 16FR SILVER FLY TY  Item Code:  PP16XSD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover MIDSTREAM KIT CASTILE SOAP  Item Code:  2040SA   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  PRECISION PRM 18FR SIL COUDE CATH SECURE   Item Code:  PP18CSD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover MIDSTREAM KIT RING CASTILE  Item Code:  4090SA   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  MIDSTREAM KIT CASTILE SOAP  Item Code:  2090SA  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE  Item Code:  P4P16CSD     Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover P400 PREM U/M 16FR SIL FLY  Item Code: P4P16SD   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  PREM 16FR UL LTX FOLEY TRY CSD  Item Code:  PP16ULD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover   P400 PREM U/M 16FR UL FOLY CSD  Item Code:P4P16ULD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover   P400 PREM U/M 16FR SLVR FLY  Item Code: P4P16XSD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover PREM U/M 14FR SLVR FLY  Item Code:  P4P14XSD P400   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  P400 UM 16FR SIL COUDE SECURE  Item Code:  P4P16CSDK  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  KIT/STERILE PRESERVE CULT   Item Code:  8000SA  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD      Item Code: P18ULD   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover CATCH KIT SOAP  Item Code: 5205  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  PREM U/M 14FR SIL FLY  Item Code:  P4P14SD P400   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover EASY CATCH MIDSTREAM KT W/CAST  Item Code:   25015   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover   PRECSION PRM 18FR SIL FLY  Item Code: PP18SD   Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover  P400 PREM U/M 16FR TMP SNS CSD  Item Code: P4P16TSD  Castile soap towelettes are used to clean the genital area for male and female patients
Covidien Dover PRECSION PRM 16FR SIL FLY   Item Code:  PP16SD   Castile soap towelettes are used to clean the genital area for male and female patients
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
The implantable pulse generator (IPG) model 2408  had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm).  The following functions may not be available:  Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Serial Numbers:  01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
Distributed in the states of PA and MN, and the country of Switzerland.
Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
Model/Catalog: IRR-Clip-30  Lot # J023101962
Nationwide Distribution -- AR, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, WA, WI and District of Columbia.
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size  4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ.    Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous  that had a textured outer surface.
Parade Salted Peanuts Dry Roasted, Net Wt. 8 oz   Distributed by Federated Group, Inc. 3025 W. Salt Creek Ln Arlington Heights, IL 60005 UPC 050700569376
Parade Salted Peanuts Dry Roasted, 8 oz can may contain undeclared wheat.
HEB Creamy Creations Caramel Pecan Turtle Ice Cream Half Gallon/Cont. Net. 1.89 L packaged in cardboard container
SELL BY: 20 APR(ABR)16, 10 MAY(MAY)16, 07 JUN(JUN)16, 18 JUL(JUL)16
Blood products, in which labeling/labels applied to blood units or products with incorrect or missing information, were distributed.
Fabi-Saa Mote Blanco Net Wt. 14 oz. (397 g)   Imported and Distributed by Fabi-Saa Inc.   Belleville, NJ 07109 UPC 874093000090   Made in USA
Fabi-Saa Mote Blanco contains undeclared sulfites at 2.61 mg.
American Red Cross Blood Services Tennessee Valley Region
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom eligibility was inadequately determined, was distributed.
Blood product, collected within a year from a donor who lived in a malarial endemic area, was distributed.
US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
cobas p 512 pre-analytical system    Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
Source plasma product, in quarantine pending post donation investigation regarding prior incarceration, was distributed.
US: AL, AZ, CA, NC, TX, FL, GA, SC, ID, IL, LA, MI, NC, NE, MS, NV, NY, OR, Puerto Rico, TN, UT, VA, WA, WI, VT    Non US: British Columbia
Fruit & Nut Medley, Snacks Fit for a King, King Size, 12 per case.  NP- UPC 61054645419 and 61054645119.
King Henry is recalling Fruit and Nut Medley because it may contain undeclared FD&C Yellow #6.
US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France,  Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal,  Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela.
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary  anastomosis during cardiac revascularization.
542  (351 SCC Touchpads and 191 PSC touchpads)
Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.
serial numbers: See attached distribution list.  128 RT -3100 and 2565 RT-5100.
Chappaqua Crunch Simply Granola with Blueberries & Bananas, in 13 ounce clear plastic pouch. UPC:7 86516 16007 9
Product may be contaminated with Salmonella.
Best by dates Feb 5, 2016 through May 31, 2016. Best by dates are on the back of the plastic pouch.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
CA, MI, OR and TN.    No distribution to schools or military.  No distribution outside the U.S.
Product is blanched then frozen and placed in a plastic lined cardboard box.    UPC 1 06 81241 05167 8
ConAgra is recalling one lot of Watts Bros Super Sweet Cut Corn bulk packed, due to the potential to be contaminated with Listeria monocytogenes.
Lot code on package P: 2015. 12. 05.  Manufacturing date December 5, 2015.  Expiration date December 5, 2017 (E: 2017. 12. 05).
US Distribution to states of: FL, NJ, AZ, and NC.
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization    The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.
Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.
The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.
International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10    (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
ShopRite Dry Roasted Unsalted Cashews 7 oz. (198 g)  Distributed by Wakefern Food Corp., Elizabeth, NJ 07207  UPC 4119001620
Recalled product may be mislabeled as ShopRite Unsalted Dry Roasted Cashews.
Domestic: Indiana, Kentucky, Michigan, Ohio, Pennsylvania,  Tennessee, Wisconsin and West Virginia.    Foreign: None  VA/DOD: None
Dark Chocolate Covered Coffee Beans, packaged in 12 oz. tubs
Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds).
US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile   for use as an alternative to a face mask for achieving and maintaining control of the airway during routine  emergency anesthetic procedures.
Total Numbers of unit distributed: 45990 pes (USA)
Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the  problem  during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product  and,ultimately,patient complications.
Catalog Number:408300000    Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239,  1795914      Catalog Number: 408400000  Size #4 All lots from 1632799 through lot number 1790075.      Catalog Number:408500000  Size #5 All lots from 1632802 through lot number 1810863.
Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
QFT TB Antigen Tube.    QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
The total amount of product distributed 152,900 Tubes
Potential for obtaining a false positive  result  due  to  the  possibility  of  endotoxin presence.
ICA GOURMET SEASONINGS, SESAME GARLIC DIP, 02-4772R1, NET WEIGHT 25 POUNDS, INGREDIENTS CORP. OF AMERICA, INC.
Glass shards were found in a sealed bag of dehydrated minced garlic.  Parts of this shipment of garlic were used to manufacture other products.
BIG BOB GIBSON B-B-Q Seasoning and dry rub, 6.35 oz, 180.0225 g., Distributed by Mrs. Stratton's Salads, Inc., Birmingham, AL, UPC 8366577777
ICA GOURMET SEASONINGS, No Salt Added, nsa SEASONING, House Seasoning, NET W. 20 oz  (1 LB. 4 OZ.) 567g, Packed by Ingredients Inc., Memphis, TN
KD's GOOD STUFF SEASONING, NET WT. 5#, KD's, 5395 McKinstry, Moscow, TN, 38057
ICA GOURMET SEASONINGS, SIDE CAR HOUSE BLEND LESS SALT, 02-3992R4, NET WEIGHT 25 POUNDS, INGREDIENTS CORP. OF AMERICA, INC.
C & J BUTCHER SHOP, Recipe #10 BBQ Sauce, Net Wt. 763 oz. and 18.5oz., developed by & Available only from C&J Butcher Shop, Granbury, TN 76048
Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally  to CHINA.
Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
US Nationwide Distribution in the states of CA ,CO, OH, OR
Neurotherm  Curved Radiofrequency (RF) cannnula 10 cm   18 gauge, 10 mm active tip  Model Number: C-1010-R-18    Product Usage:  The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.
Straight needle labeled as a curved needle
Dried lactose powder, product sold under brand Wine-King Beer-King,  packaged in three consumer-sized plastic bags of 4 oz., 1 Lb. and 5 Lb. net weight.
55/4 oz. bags; 247/1 lb. bags; and 45/5 lbs. bags
Dried Lactose powder product, which is used in brewery to make beer, does not declare whey or milk and the label declared lactose only.
Bi-Lo, Fresh Cantaloupe, Chunks Medium Container, Chunks Large Container, Halves and Slices, various net wt., in clear plastic containers.
Product sample result tested positive for Listeria species.
Cantaloupe Chunks Medium Container  UPC 020436000000, SELL BY 2/24/16, Cantaloupe Chunks Large Container  UPC 020463100000, SELL BY 2/24/16 and Cantaloupe Halves  UPC 020434600000, SELL BY 2/24/16.
Bi-Lo, Mixed Melon Chunks (in Medium, and Large containers), containing Cantaloupe, Honeydew and Watermelon, various net wt. in clear plastic containers.
Mixed Melon Chunks Medium Container  UPC 020436300000, SELL BY 2/24/16 and  Mixed Melon Chunks Large Container  UPC 020436400000, SELL BY 2/24/16
Bi-Lo, Mixed Fruit Bowl (in Medium, and Large containers), containing Strawberries, Grapes, Honeydew, Cantaloupe, Pineapple, Watermelon, Blueberries, Blackberries, Raspberries and Kiwi, various net wt., in clear plastic containers.
Mixed Fruit Bowl Medium Container  UPC 020448300000, SELL BY 2/24/16 and Mixed Fruit Bowl Large Container  UPC 020448100000, SELL BY 2/24/16.
Bi-Lo, Walters Fruit Tray Cantaloupe (Cantaloupe, Grapes and Strawberries), various net wt., in clear plastic trays.
U.S. distribution to the following; CA, KS, TX, NE, NY, IL, MT, MO, UT, ID, AZ, HI, TN, OR, NJ, GA, WI, FL.    Foreign distribution to the following; QC, UK, PH
NP Nutra  Spinach Powder Organic   SKU: 790  Net Weight: 22.72kg  Gross Weight: 24kg  Product of USA
Np Nutra is recalling Spinach Powder (Organic) because of potential Salmonella contamination.
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
Cross contamination with other products: metronidazole
American Natl. Red Cross-Greater Chesapeake & Potomac Region
Misbranded Red Blood Cells were distributed.
Nationwide Distribution to  IL, NY, MT, and MN.
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media.  It is used for diagnostic image viewing and post processing during interventional procedures.   .
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
DiGiorno pizzeria thin crust spinach & mushroom pizza, UPC 71921-58570,  Keep Frozen.  Net Wt. 18 oz (1 lb 2 oz) 511g
Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.
Production code:  6009525952.  Best Before:  Aug 2016
Lean Cuisine Marketplace Ricotta Cheese & Spinach Ravioli, UPC 13800-93052,  Keep Frozen.  Net Wt. 8 oz (226g)
Production codes:  6004595912, 6005595912.  Best Before:  Feb 2017
Stouffer's spinach souffle.  Simple Dishes.  Keep Frozen. Net Wt. 12 oz (340 g)  UPC 13800-10585.
Production codes  5353595528, 5353595538 and Best Before:  July 2016
Stouffer's vegetable lasagna.  Keep Frozen. Sold in the following sizes and UPC:  1.  Party Size  Net Wt. 96 oz (6 lb) 2.72kg  UPC 13800-19002.  2.  Net Wt. 10 1/2 oz (297g)  UPC 13800-10323.  3.  Family Size Net Wt. 37 1/2 oz (2 lbs. 5 1/2 oz) 1.06 kg, UPC 13800-55510.  4.  Food Service Professional Product Net Wt. 6 lbs (2.72 kg)  UPC 13800-30322.(this product is not available in retail stores)
Lean Cuisine Marketplace Mushroom Mezzaluna Ravioli, UPC 13800-58358,  Keep Frozen.  Net Wt. 8-5/8 oz (244g)
Production codes:  5348587812 and 5349587812.  Best Before:  Jan 2017
DiGiorno Rising Crust Spinach and Mushroom Pizza, UPC 71921-00335, Keep Frozen.  Net Wt. 30.3 oz (1 lb 14.3 oz) 858g
Lean Cuisine Craveables Deep Dish Spinach & Mushroom pizza, UPC 13800-13520,  Keep Frozen.  Net Wt. 6-1/8 oz (173g)
Lean Cuisine Marketplace Spinach Artichoke Ravioli, UPC 13800-55806,  Keep Frozen.  Net Wt. 9 oz (255g)
Production codes:  5362587812, 5363587812.  Best Before:  Jan 2017
DiGiorno Thin & Crispy Spinach and Garlic Pizza, UPC 71921-45143, Keep Frozen.  Net Wt. 11.9 oz (337g)
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products, for which quality control testing for residual white blood cell count was not performed, were distributed.
St Mary's Hospital and Medical Center, Inc.
Apheresis products collected from a donor who should have been deferred for reactive syphilis test were distributed.
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Distributed to Colorado, Wyoming, Utah, and New Mexico (149 King Soopers and City Market stores).  No foreign or govt/military/VA consignees.
Bakery Fresh Goodness Apple Strudel 5 count, 24oz, packaged in Plastic container, distributed by King Soopers Bakery, Denver, CO.
King Soopers is recalling Apple Strudel 5 Count because they were incorrectly labeled and does not declare pecans in the ingredient statement.
Insects (Whole Body), Mite Dermatophagoides farinae
Six (6) 10mL vials have been distributed to one customer.
Misbranded allergenic extracts, were distributed.