Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
100% APPLE CIDER 1 Gallon (3.78L) UV TESTED KEEP REFRIGERATED UPC 0 85591 00128 1
Myers Cider Mill LLC, of Monroeville, Ohio has issued a  voluntary recall of apple cider due to a process deviation.
All products with press dates between 9/1/16 - 10/15/16
AL, CA, FL, MS, NC, NJ, NY, TN, and TX.  Outside the US:  Israel
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445.  Sterilized using Ethylene Oxide
The sterile packaging may contain small channels in the seal of the pouch,  If the channels are present, the package integrity may be compromised which may affect sterility assurance.
Lot Number:  163010  Expiration date:  June 2021
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package  UPN), M001316580, single unit, inner package UPN)
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling.  The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
Lot:  00116127, Expiration Date:  September 30, 2018
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use,  60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873,   Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC  43386-069-60
Nationwide Distribution  to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS,  MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C.
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0  RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs
Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only.  There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile.  This could cause an end user to use a non-sterile sheath as if it were sterile.
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only .  There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502   The Hyfrecator 2000 Electrosurgical Unit is indicated for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only.  There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO  -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile.  This could cause an end user to use a non-sterile sheath as if it were Sterile.
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only,  There is no problem with the Hyfrecator 2000 Electrosurgical Units ---  ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---
US Nationwide.    AUSTRALIA  BANGLADESH  BRAZIL  CANADA  CHINA  GERMANY  INDIA  ITALY  KUWAIT  PAKISTAN  SAUDI ARABIA  THAILAND  UNITED ARAB EMIRATES  CYPRUS  GREECE  NETHERLANDS
TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring  and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.
P1900  SN: K328AM6065 to Q245AM0691  PR1900   SN: L082AL7316 to R343AL4516  U1900   SN: L257AM0541 to O311AM7169  Scale Upgrade Kit P1957A produced after March 13, 2013 (not serialized).
A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
Worldwide Distribution - USA (nationwide) Distribution
Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery.  The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
Maggi 2 Minute Noodles, Net Wt. 19.75 oz., 2.46 oz. and 9.87 oz.
Product was distributed throughout the US and to Australia, Belgium, Canada, Finland, Germany, Hong Kong, Israel, Italy, Japan, New Zealand, Norway, Poland, Portugal, the Russian Federation, Singapore, Spain, Sweden, Switzerland, Turkey, and the UK.
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.     After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.
Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool:  When the StrataMR valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in CSF fluid performance.  This condition may result in the following adverse health consequences:  ventriculomegaly, headaches, nausea, vomiting and lethargy.  If left untreated, underdrainage has the potential to lead to coma and death.
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI.  Foreign: None
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional  reformatter (BRF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full.  This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.
Cobas 8100 bi-directional reformatter (BRF)  module with Software Version 02-xx   Catalog Number: URF module: 07441657001
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Cobas 8100 bi-directional reformatter (BRF)  module with Software Version 02-xx   Catalog Number: 743995400
I.M. Healthy, Unsweetened SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
Potential contamination of product with E. coli O157.
I.M. Healthy Raisin & Cranberry Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
40,752 individual cases; 42 25LB bags; 558 6-pack 12oz bags
I.M. Healthy Blueberry Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
I.M. Healthy, Original Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
162,000 individual packets; 60 25LB bags; 18,640 50oz bags; 1,428 6-pack 12oz bags
I.M. Healthy, Chocolate SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
18,900 15oz jars; 296 4LB tubs; 175,968 individual cups
I.M. Healthy, Chunky SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
Dixie Diners' Club Carb Not Beanit Butter, 15oz., Dixie USA, Inc., P.O. Box 1969, Tomball, TX 77377
I.M. Healthy, Creamy SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
642,060 15OZ jars; 32,034 4LB tubs; 436,608 individual cups; 1,275 45LB pails
I.M. Healthy Apple Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
12,528 individual packets; 17 25LB bags; 360 6-pack 12oz bags
I.M. Healthy, Honey Creamy SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
B'Gan Quality Product, SoyNut Butter, Creamy; Dist. By: S. Bertram Inc, Linden, NJ 07036
PerkinElmer Life and Analytical Sciences, Wallac, OY
Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
Specimen Gate Laboratory; Product Number: 5002-0180  Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Lake Fresh Whole Smoked Tilapia Net Wt 8 oz  Capital Street LLC Old Bridge, NJ 08857 UPC 0680296079
NYSDAM sampling and analysis has determined that Lake Fresh Smoked Tilapia is un-evsicerated.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Hot Cocoa Snowballs contain chocolate shell filled with dry hot cocoa mix, 100g (3.5 oz), the product is packaged in a clear plastic box.
undeclared soy lecithin and milk (cream was declared)
undeclared soy lecithin and milk (cream was declared).
Milk Chocolate Almond Toffee Tree contains 3D chocolate holiday tree with toffee and almonds, net wt. 140g (4.9 oz), Product packaged in clear plastic box with ribbon.
Assorted Bonbons are molded chocolates with ganache fillings in assorted flavors, No package weight.  Product packaged in a black plastic tray and then tray is placed in a paper box with clear plastic lid.
Dark Chocolate Pretzel Bar contains dark chocolate and pretzels, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
Hazelnut Truffles are dark chocolate with hazelnut ganache, 3.9 oz (110g), individually wrapped in clear cellophane and then wrapped in a paper box.
Dark Orange Bar is dark chocolate with bits of candied orange zest, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
Espresso Caramels are caramels flavored with expresso, 3.9 oz (110g), individually wrapped in cellophane and then wrapped in a paper box.
undeclared soy lecithin and milk  (butter and cream were declared).
Black and Tan Bar contains dark chocolate and white chocolate with cocoa nibs, 1.2 oz (33g), Product wrapped in metal foil and then wrapped in a paper box.
Dark Chocolate Hazelnut Bar is dark chocolate with milk chocolate and hazelnuts, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
White Chocolate Sweet & Salty Almond Bar is also called Salty Almond Bar.  It  is white chocolate almond with sea salt, 1.2 oz (33g), product is wrapped in metal foil and then wrapped in paper box.    The ingredients statements declared: 32% caramelized white chocolate, almonds, salt
Milk Chocolate Almond Heart contains solid milk chocolate with almonds, 110g (4 oz), the product is packaged in a clear plastic box.
Maple-Pepper Caramels are caramels with maple syrup and black pepper, 3.9 oz (110g), individually wrapped in cellophane and then wrapped in a paper box.
undeclared soy lecithin and milk  (cream and butter were declared).
Hot Cocoa Heart is dark chocolate shell filled with dry cocoa mix, 2.8 oz (80g), the product is packaged in a clear plastic box.
undeclared soy lecithin and milk (cream and butter were declared)
Dark Chocolate Toffee Santa, dark chocolate with bits of toffee, 150g (5.3 oz), the product is packaged in a clear plastic box.
Dark Chocolate Coconut Bar is dark chocolate with white chocolate and coconut, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
undeclared soy lecithin and milk (cream and butter were declared).
Dark Chocolate Peppermint Snowflakes are dark chocolate flavored with peppermint oil, 100g (3.5 oz), the product is wrapped in a plastic heat sealed bag.
Worldwide: United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.
Lot 1570 (expiry 22 March 2017),   Lot 1580 (expiry 13 April 2017),   Lot 1590 (expiry 27 April 2017)
Klassic COCONUT DESSICATED COCONUT, 25 LBS. NET, ORGANIC MEDIUM BMO25, PRODUCT OF PHILIPPINES
Gerber Products Company dba Nestle Infant Nutrition
Connecticut, Massachusetts, Maine, New Jersey and New York
Vulto Creamery Miranda soft wash-rind raw milk cheese cut and wrapped in clear plastic
Possible contamination with Listeria monocytogenes.
Vulto Creamery Ouleout soft wash-rind raw milk cheese cut and wrapped in clear plastic
Vulto Creamery Walton Umber raw milk cheese cut and wrapped in clear plastic
Vulto Creamery Hamden raw milk cheese cut and wrapped in clear plastic
Vulto Creamery Andes raw milk cheese cut and wrapped in clear plastic
VEGETARIAN TUNA FISH, 5 1/3 oz.. cans, 24 cans per case.     Product of Taiwan  UPC CODE: 0 76277 10500 1    Companion Foods Corp. Taipei, Taiwan
20 cartons (24 x 5 1/3 oz. tins per carton)
An FDA inspection at  the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list.  Wheat is listed in the Contains statement.
BRAISED BAMBOO SHOOT TIPS WITH CHILI, 10 oz. cans, 24 cans per case.     Product of Taiwan  UPC CODE: 0 76277 10058 3    Companion Foods Corp. Taipei, Taiwan
1,082 CTNS (24 x 10 oz. tins per carton)
FAT-CHOY STYLE VEGETABLE SOUP, 15 oz. cans, 24 cans per case.     Product of Taiwan  UPC CODE: 076277 10960 9    Companion Foods Corp. Taipei, Taiwan
30 cartons (24 x 15 oz. tins per carton)
SZECHUAN STYLE KUNG-PAO SAUCE (HOT PAPAO LAJAN), 10 oz. cans, 24 cans per case.     Product of Taiwan  UPC CODE: 0 76277 10395 9    Companion Foods Corp. Taipei, Taiwan
140 Cartons (24 x 10 oz. tins per carton)
LOT NUMBERS: 4808-BV25A,6225-BV25B  BEST BEFORE DATES: 8/8/2017, 2/25/2019;    LOT NUMBERS: 6225-BV25B  BEST BEFORE DATES: 2/25/2019.
VEGETARIAN MINCED MEAT WITH SHIITAKE 5 1/3 oz.. cans, 24 cans per case.     Product of Taiwan  UPC CODE: 0 76277 10932 6    Companion Foods Corp. Taipei, Taiwan
50 cartons (24 x 5 1/3 oz, tins per carton)
LOT NUMBERS: 2019.08.08AB  BEST BEFORE DATES: 8/8/2019;
BRAISED BAMBOO SHOOT TIPS 10 oz. cans, 24 cans per case.     Product of Taiwan  UPC CODE: 0 76277 10060 6    Companion Foods Corp. Taipei, Taiwan
BRAISED BEAN CURD (MOCK CHICKEN)10 oz. cans, 24 cans per case.     Product of Taiwan  UPC CODE: 0 76277 10419 2    Companion Foods Corp. Taipei, Taiwan
New York, New Jersey, Connecticut, Rhode Island, New Hampshire, Massachusetts, Maine, Vermont, Pennsylvania, Delaware, Maryland, West Virginia, Virginia, Washington DC, North Carolina, South Carolina, Kentucky, Florida, Ohio, Michigan, Indiana, Wisconsin, Illinois, Tennessee, Alabama, Mississippi, Louisiana, Arkansas, Iowa, Minnesota, North Dakota, South Dakota, Nebraska, Texas, Missouri, Kansas, Oklahoma, Colorado, New Mexico, Wyoming, and Montana.
LIDIA'S MARINARA, NET WT 25 oz (708g), UPC 897712001018 ---  Manufactured for Nonna Foods LLC Woodbury, NY 11797
750 jars of Lidia's Vodka Sauce were mislabeled as Lidia's Marinara Sauce
The product may contain undeclared milk due potential product mix-up.
Best By Date  06/13/2019 (found on the neck of the jar)
7-Eleven, Mantecada MUFFIN, Net Wt. 4 oz. , UPC 05254859241-7, in clear flexible plastic, Distributed by 7-Eleven, Inc., Irving, TX 750634.
Good Plenty Brand Supreme Abalone Noodles, 21.2 oz. box.  Each box contains Retort pouch of Noodles and Abalone.  These two pouches are packed together in the box; 10 boxes per case.
During an FDA foreign inspection, it was discovered that Wheat was not properly declared on the product labeling. Wheat is an ingredient in the noodles contained in the product. Wheat is listed in the Contains statement.
Noodle Pack: serial numbers :1-238, expiration date:23/Dec./2017  Abalone Pack: serial numbers : 1-217, expiration date:23/Dec./2017
Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609.
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand
Bedside monitor  CSM-1901(Life Scope G9) with main unit CU-192RA.  The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Lot/Unit Codes: G9  Serial Number: 230 (UDI: 01049319211121682100230)  Serial Number: 232 (UDI: 01049319211121682100232)    Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software.    Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.
Miranda, 5 lb. wrapped in paper;        Vulto Creamery, Walton, NY.
Firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.
Hamden, 3.5 lbs. wrapped in paper    Vulto Creamery, Walton, NY.
Ouleout, 1.5 lbs. wrapped in paper    Vulto Creamery, Walton, NY.
Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
VIDAS Estradiol II, Ref 30431-01, 60 tests  The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
LATANOPROST OPHTHALMIC SOLUTION, 0.005%,  125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only,  Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ ---  NDC 57237-041-99
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
US:AK, AL, AR, AZ, CA,  CO, CT, DE, FL,  GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, NE, NJ, NM,  NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY.      OUS: Canada
Shred Carrots, 3 lb Food Service plastic bag.
J&J Distributing Company reported that a small amount of shred carrots were contaminated with metal pieces. The shred carrots were used as ingredient for other RTE items.
Kowalski's Markets, Carrot, Apple, Hummus Wrap UPC 6-10014-09915-2 & Vegetable Wrap UPC 6-10014-08723-4 , 11 oz in plastic container.
Kowalski's Markets, Salad Super Kale, UPC 6-10014-14316-9,  9 oz in plastic container.
Mix General Tso Chik, 2 lbs  Food service plastic bag for Food Service (Supervalu & Franchise).    Chinese Chicken Salad, 2.65 lbs for Food Service (Franchise) in Food service plastic bag.
Kowalski's Markets, Protein Powerhouse, UPC 6-10014-14692-4,  8 oz in plastic container.
Detox Salad, 8 oz. Plastic deli container with various brand names: Cub Foods (Fresh) UPC 610014-155698 , Cuttin' Time UPC 610014-160876, .Country Market UPC610014-154929 , Jerry's UPC 610014-154103.
Cub Foods (Fresh), Cranberry Walnut Salad, UPC 0-41144-37302-5,  20 0z. Plastic deli container.  Kowalski's Markets, Salad Greens, Cranberry Walnut Salad, UPC 6-10014-14320-6, 9 oz. Plastic container.
Rainbow Coleslaw, 5 lbs for Food Service (Franchise) in Food service plastic bag.
Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures.  It has a soft wristband with a secure hook and loop fastener.  The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe.  A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.
Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.
Product was distributed throughout the United States and Canada.
AESCULAP MINOP InVent 30 Trocar System, non-sterile      Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
Aesculap Implant Systems LLC is recalling the Minop Trocar due to the  possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189.  Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Lasik Tray, part number DDS1045-2  Product packaged in a convenient manner for use in a general clinical procedure
Eye Pack, part numbers WAL1085(B and WAL1085(C\  Product packaged in a convenient manner for use in a general clinical procedure
Vitrectomy Pack, part number AMS4952    Product packaged in a convenient manner for use in a general clinical procedure
Custom Tray, part numbers PSS1111 and PSS1111(A.    Product packaged in a convenient manner for use in a general clinical procedure
Ophthalmic Pack, Part number WAL1107(A and WAL1190    Product packaged in a convenient manner for use in a general clinical procedure
Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A.  Product packaged in a convenient manner for use in a general clinical procedure
Vitrectomy Kit, part number CMP1016(A.  Product packaged in a convenient manner for use in a general clinical procedure
Cataract Kit, part numbers CAT1467AM and CAT1538(B.    Product packaged in a convenient manner for use in a general clinical procedure
Cataract Kit - Dr. Slingsby, part number CMP1017(B.  Product packaged in a convenient manner for use in a general clinical procedure
ENT Pack, part number AMS2727  Product packaged in a convenient manner for use in a general clinical procedure
Setup Pack, part number AMS3112(A  Product packaged in a convenient manner for use in a general clinical procedure
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1  Product packaged in a convenient manner for use in a general clinical procedure
Dicken Eye Pack, part number CPA-3202-2.    Product packaged in a convenient manner for use in a general clinical procedure
PRK Tray, part number DDS1044    Product packaged in a convenient manner for use in a general clinical procedure
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A  Product packaged in a convenient manner for use in a general clinical procedure
Minor Operation Kit, part number AMS1530  Product packaged in a convenient manner for use in a general clinical procedure
Ortho Basic Pack, part number AMS6459	    Product packaged in a convenient manner for use in a general clinical procedure
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x  11.5mm.  Catalog Number(s): 15636K
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA
ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18.  Sterilized with Ethylene Oxide.      The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip.  The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft.  The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.
Volt Resistance Heated Slipper Black (All sizes)  Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Volt Resistance Heated Slipper Gray (All sizes)  Deep penetrating heat garment and wraps
Volt Resistance Unisex Rechargeable Heated Slipper  (All sizes)  Deep penetrating heat garment and wraps
Volt Resistance Heated Socks (All sizes)  Deep penetrating heat garment and wraps
Volt Resistance Heated Elbow Garment   Deep penetrating heat garment and wraps
Volt Resistance Heated Therapy Foot Wrap  Deep penetrating heat garment and wraps
Volt Resistance Heated Neck Garment   Deep penetrating heat garment and wraps
Volt Resistance Heated Lower Back Garment  Deep penetrating heat garment and wraps
Volt Resistance Heated Therapy Knee Wrap  Deep penetrating heat garment and wraps
Volt Resistance Heated Slipper  (All sizes)  Deep penetrating heat garment and wraps
Volt Resistance Frostie Heated Gloves (All sizes)  Deep penetrating heat garment and wraps
Volt Resistance Heated Therapy Shoulder Wrap  Deep penetrating heat garment and wraps
Distributed in WA and sold to internet customers through www.2020lifestyles.com.
20/20 LifeStyles Yogurt Peanut Crunch Bar.    Bar   UPC 7 8571 00052.  Each bar has net weight 2 oz.  Box  UPC 7 8571 00053.  Each box has 12/2 oz. bars.  Case UPC 78571 00054.  Each case has 12 boxes and it is for shipment only  and not for resale.
Product is recalled due to a potential contamination with E. coli O157:H7.
B.B. 22JUL17 2046     This lot means Best By July 22, 2017 and Julian date 2046 represents the production date.
United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden,  Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland,  Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar,   Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India, Hungary,   Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland,   Estonia, Egypt, Ecuador, Denmark, Czech Republic, Croatia, Colombia,   Chile, Canada, Bulgaria, Brunei Darussalam, Brazil, Belgium, Austria,   Australia, Argentina, Vietnam.  Uruguay, Taiwan, Slovakia, Singapore, Reunion, Qatar, Panama, Pakistan, Jordan,   Indonesia, Guadeloupe, Czech Republic
GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.
Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
MEDTECH ROSA Spine 1.0.2  The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.
MEDTECH ROSA Brain 3.0  The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.
The recalled product was distributed to the following state: OH.  There are no Canada accounts for this recall.  There are no Mexico accounts for this recall.  There are no government accounts for this recall.
Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ --  NDC 0054-0338-19
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
Merge Hemo software.  The firm name on the labeling is Merge Healthcare, Hartland, WI.  Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
24 sites potentially have the affected versions
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Worldwide - US Nationwide distribution in the states of: AL, CA, GA, IL, LA, MA NY, OH, PA, TN, TX and VA and the countries of:  AR  AT  BE  BG  BN  BO  BY  CA  CH  CL  CO  CZ  DE  EG  ES  FI  FR  GB  GR  HR  HU  ID  IE  IL  IN  IT  LT  MX  MY  NL  NO  NP  PA  PE  PK  PL  PT  RO  RS  RU  SA  SE  SK  TH  TR  TW  UG  UZ  VN  ZA
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL  60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04)  and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04),  and e) 100 grams (NDC 38779-0891-09)  Bottles,  Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC.  PLATTSBURGH, NY 12901; Product Code 0732
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter;  Product number: 400-0200.273; Catalog number 89900.      Cardiovascular:  The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter.  Kinking could result in disruption of normal clinical workflow or loss of imaging.
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter;  Product number: 400-0200.289; Catalog number 89800.      Cardiovascular:  The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.
Economic &amp; Technological Development Zon
Product distributed to NY, TX, SC, CO, MN and NJ
Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by  Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China  (NDC 44132-002-05)
cGMP Deviations; lack of quality assurance.
Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)
Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China  (NDC 44132-012-01),
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
Distribution was made nationwide to medical facilities.  Foreign distribution was made to Canada, as well as other countries.  Government/military distribution was also made.
iConnect Enterprise Archive (ICEA) software.  The firm name on the labeling is Merge Healthcare, Hartland, WI.
333 sites potentially have the affected versions
An error message can occur resulting in the prior studies being unavailable for viewing.
US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi  Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD  21801, USA.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD  21801, USA.
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD  21801, USA.