Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Retail stores located in Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, North Carolina, New York, New Jersey, New Mexico, Nevada, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia.
Organic traditions brand DARK CHOCOLATE HAZELNUTS,  NET WT. 3.5 oz (100 g) - UPC 8 54260 01400 6, and NET WT. 8 oz (227 g) - UPC 8 54260 00701 5 -- Product of Italy --- Distributed by Organic Traditions - Cheektowaga, NY 14227
The imported products were found to contain undeclared milk (casein) based on analyses by the Canadian Food Inspection Agency (CFIA).
Organic traditions brand DARK CHOCOLATE ALMONDS WITH CHILI, NET WT. 3.5 oz. UPC 8 54260 01550 8, and NET WT. 8 oz. UPC 8 54260 00707 7;  the product was also distributed in cartons containing 2 x 12 lbs. bulk bags (totaling 24 lbs.). -- Product of Italy --- Distributed by Organic Traditions - Cheektowaga, NY 14227
Organic traditions brand DARK CHOCOLATE ALMONDS, NET WT. 3.5 oz. (100 g) - UPC 8 54260 01500 3, and NET WT. 8 oz. (227 g) - UPC 8 54260 00705 3;  the product was also distributed in cartons containing 2 x 12 lbs. bulk bags (totaling 24 lbs.). -- Product of Italy --- Distributed by Organic Traditions - Cheektowaga, NY 14227
Organic traditions brand DARK CHOCOLATE HAZELNUTS WITH CHILI, NET WT. 3.5 oz. (100 g) - UPC 8 54260 01450 1, and NET WT. 8 oz. (227 g) - UPC 8 54260 00703 9; the product was also distributed in cartons containing 2 x 12 lbs. bulk bags (totaling 24 lbs.). -- Product of Italy --- Distributed by Organic Traditions - Cheektowaga, NY 14227
Worldwide Distribution - US Distribution to the states of :  IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes:  1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001    Patent airway management.
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc.    Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
Possible inner labeling and packaged device not matching the outer label on the box.
Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc.,       Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
Catalog Number 350-21-13, Serial Range 4536756 - 4536764, Expiration August 2024
Nationwide     Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
PENTARAY NAV High-Density Mapping Catheter.
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Distributed to the following states: CA, CO,  GA, IL, IN, MI, NM, NY,  OH, PA, TN, TX, UT, WA, WI.      Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FA, HI, IA, IS, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT & WA; International - Canada, Guam and Japan
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261  Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.
Listeria monocytogenes contamination of non-sterile plated media
Lot Number: 7032978 - Exp Date May 24, 2017                          7048902 - Exp Date June 9, 2017
Worldwide Distribution - US (Nationwide) and Canada
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017  The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature.  After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
BD Precision Glide Needle 18G x 1  RB, Catalog 305195    Product Usage:  These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
Hub damage resulting in breakage and/or leakage during use.
Lot Number: 6152995  Expiration Date: 31-Jul-21
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 &  FVG8135
GE Medical Systems Information Technologies, Inc.
Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software  The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Worldwide Distribution - US including CA, NC & TN  Internationally: Canada
system, which performs identification and susceptibility testing
Potential unexpected movement of robot arm
Big Gain Wisconsin, 2205, 20% Total Calf B45 Fly, Medicated.  For dairy calves from birth to 5 weeks of age.  Active Drug Ingredient Lasalocid 45.0 g/ton and Diflubenzuron 4.56 g/ton.    Net Wt. Bulk or 50 Lb (22.67 kg).  Manufactured by:  Big Gain Wisconsin, LLC, W9077 Schutz Rd., Lodi, WI  53555
Calf Starter Feed may contain excess Salt.
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg),  1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336    Product Usage:  Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.
Distribution of unapproved devices with incorrect air compression level setup
Serial numbers: EMM16100968 and EMM16100967  MFG DATE: 2016.10.10
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses)    Product Usage:  Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor whose suitability was not adequately determined, was distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with a low platelet count, was distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Pooled Cryoprecipitated AHF units, not prepared in accordance with specifications, were distributed.
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor whose suitability was not adequately determined, were distributed.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and  Philippines
ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:  (a) 16037-64-01; MedNet 6.1  b) 16037-64-02; MedNet 6.1  c) 16037-64-03; MedNet 6.1  d) 16037-64-04; MedNet 6.21      The ICU Medical MedNet  Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.
Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when:  1.	Medication entries are built with the same displayed name and diluent amount AND;  2.	The piggyback or interruptible settings differ from one CCA to another AND;  3.	The drug library is exported then imported into the MedNet Meds program.    The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered.  Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when:  1.	The Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND;  2.	The medication entry built as the Full rule set has a blank medication amount with the medication units in  mg  AND;  3.	Both medication entries have different piggyback options set AND;  4.	The drug library is exported then imported into the MedNet Meds program.    In this case, the piggyback options will be changed during an import of such drug library.
Environmental samples collected by FDA at the firm resulted in 8 out of 50 samples positive for Listeria monocytogenes in zones in direct contact with product.
No Sugar Added Butter Pecan Ice Cream 3 gallons
Worldwide Distribution - US Nationwide and in the countries of  UK, and Japan and via distributors in the other countries
Fukuda Denshi patient monitor model DS-8100M and DS-8100N    Product Usage:  Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a  Short-term Battery Error  message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup).
all DS-8100 units manufactured and distributed worldwide.
Distribution was made to AL, MD, ME, NC, and TN.  There was no foreign/military/government distribution.
CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Product may have incorrect cation information detailed on the product label.
GOYA Adobo, All Purpose Seasoning with Pepper, Goya Foods, Inc. 28 OZ
Positive results for Salmonella from environmental test conducted at plant and finished product.
GOYA Adobo, All Purpose Seasoning with Cumin, Goya Foods, Inc. 28 OZ
Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY  The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures.  The breakage occurred at the very distal end of the conical part of the skull pin tip.
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only,  Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC  342806263013
US Nationwide distribution in the states of GA, IN, FL, and PA
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads:  a) Incision and Drainage Tray, REF 47-763.04  b) Incision and Drainage Tray, REF 47-763.06  c) Incision and Drainage Tray, REF 47-763.07  d) Cricothyreotomy Ambulance Kit, REF 89-6752.01  e) Incision and Drainage Tray, REF 89-6818.02  f) Plastic Pack, REF 89-7212.04  g) Plastic Pack, REF 89-7212.05    Product Usage:  Custom surgical and procedural kits
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Krispy Kreme Doughnuts, Glazed Pumpkin Spice Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Foreign Matter (a 1/8  long x 8mm, white & blue strand) found on product.
Products manufactured on 11/01/2017, with Sell by Date: 11/11/2017.
Krispy Kreme Doughnuts, Glazed Blueberry Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Foreign Matter (a 1/8  long x 8mm, white & blue strand) was found on the product.
Krispy Kreme Doughnuts, Glazed Mini Crullers, Net Wt. 10 oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Products manufactured on 11/01/2017, with Sell by Date: 11/07/2017.
Krispy Kreme Doughnuts, Glazed Cake, Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Krispy Kreme Doughnuts, Glazed Mini Crullers, Krispy Juniors, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Krispy Kreme Doughnuts, Original Glazed Doughnuts, Net Wt. 9.4oz (half dozen) and Net Wt. 18.7oz (one dozen), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Krispy Kreme Doughnuts, Original Glazed Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Juanita's Brand OJOS Mexican Pastry.  Product are pink balls of cake rolled in coconut packed in a flex plastic bag of varying weight. 6 units per bag.  UPC 48867 00216.
Juanita 's Brand OJOS Mexican Pastry, 6 counts in plastic bag, is recalled due to undeclared coconut.
Best Before (30 days from production date).  Production dates between 9/1/17-11/7/17.
Raley's Purely Made Dry Roasted Unsalted Peanuts; 12 oz. (340 g) clear plastic bag.  No artificial ingredients.    Some packages may be labeled as Raley's Purely Made Macadamia Nuts, 6.5 oz. (184 g) clear bag
Some packages of Dry roasted unsalted peanuts packed in 12 oz. clear package may be packed in a bag labeled as  macadamia nuts.
Thru out the United Sates and two foreign countries
FLAVORx Sweetening Enhancer , the product is packaged as follows:    Vet Sweetening Enhancer AQ, 2oz Bottle, Lot #161269 / Exp. Date 12/2018    Package type: Amber Glass Boston Round Bottles
FLAVORx Inc. has decided to recall the following product FLAVORx Sweetening Enhancer, which is a food additive used as a Pharmacy Compounding Material, because of subsequent testing of the product in there ongoing stability program  indicated that there was microbial growth in their sweetening enhancer product.
Vet Sweetening Enhancer AQ, 2oz Bottle, Lot #161269 / Exp. Date 12/2018
Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #170361 / Exp. Date 03/2019    #100 per box 1oz bottles,  #50 per box 4oz bottles    Package type: Amber Glass Boston Round Bottles
Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #170361 / Exp. Date 03/2019
FLAVORx Sweetening Enhancer , the product is packaged as follows:    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / Exp. Date 12/2018    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #4281712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #5181712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8151712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8311712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #9011712 / Exp. Date 03/2019       #50 per box 4oz bottles    Package type: Amber Glass Boston Round Bottles
Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / Exp. Date 12/2018    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #4281712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #5181712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8151712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8311712 / Exp. Date 03/2019    Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #9011712 / Exp. Date 03/2019
The American National Red Cross - Southern Region
Blood product, in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products, collected from an unsuitable donor due to a donor screening deviation, were distributed.
Roasted & Salted Cashews and Chocolate Covered Cashews; packaged in clear plastic containers; NET WT 18 oz. (1 LB 2 oz.), 510 g; UPC   8-86926-46877-9
Packages are mislabeled and actually contain undeclared mixed nuts instead of chocolate covered cashews.
Product was shipped to the following states: AL, AR, GA, IL, IN, KY, MI, MO, MS, NC, OH, SC, TN, VA & WV.
Comforts FOR BABY Purified Water with Flouride Added 1 GAL (3.78 L) UPC 0 41260 37597 2 DISTRIBUTED BY TH KROGER CO., CINCINNATI, OHIO 45202
107,874 cs/ (4 x 1 gallon jugs) and 1 gallon jugs
the firm received a complaint of mold found in the product.
Plant Code:: 51-4140 SELL BY: 05/18/18, SELL BY APR 26 18 - JUN 29 18 & SELL BY JUL 17 18 THRU OCT 10 18
Detroit City Nut LLC, initiated a voluntary recall of Dark Chocolate Almonds, Dark Chocolate Raisins, and Dark Chocolate Peanuts due to a supplier's recall for undeclared allergen milk.
UPC Codes: Dark Chocolate Peanuts  019962003592 and  Lot# 20316
UPC Codes 019962003394  Dark Chocolate Almonds 019962003493 Lot #20318
Product shipped to one customer in Virginia.
Virginia Diner, Inc. is initiating a voluntary recall of Chocolate Covered Cashews that were placed in  60 cans and sold to one direct account because of  mislabeling and peanuts were found in the cans. (Undeclared Peanut Allergen )
One distributer located in Virginia as well as their  dairy store in Maryland .
106, 18 lb buckets and 36,  40 lb buckets were made and distributed
The firm had a deviation from the Standard of Procedure in the manufacture of Clover Hill Dairy, Soft Ricotta. The facility was temporarily storing whey in a raw milk silo, without cleaning and sanitizing the silo after raw milk use.   The firm recalled the Clover Hill Dairy, Soft Ricotta.
Saranac Pasta and Seafood Salad  2x10lbs or 2x5lbs plastic tubs.
Lots: 299, 304, 311, 318, 325  Lot code on product via individually applied sticker
The firms sells their product via online sales as well as thru their retail stores located in Virginia, West Virginia, Maryland, Delaware, Pennsylvania, New Jersey, and North Carolina.
89291 Cashew Tower (Plow and Hearth Chocolate Covered Cashews). Net weight: 10 ounces .  The product is package as a Individual can is sealed tin with a plastic lid / Tower is packaged in a clear acetate (plastic) sleeve.
Plow and Hearth was notified by a manufacture of their product labeled as chocolate covered cashews were actually salted peanuts.  The firm has decided to initiate a recall of the product. (Undeclared Allergen Issue).
WOLDONG WORLD'S BEST KIMCHI WHOLE CABBAGE KIMCHI PREMIUM 3LBS (1.36kg), UPC: 8 46034 04853 9 and 7LBS (3.17kg), UPC: 846034048546.
Product contains undeclared sesame seeds.
DSM Biomedical JEN Device, Part No. 64050-04    Genius B/MC (Blood and Bone Marrow) System, 30mL Disposable Kit, Part No. 64050-04
Misbranded Genius PRP System and B/M/C Systems were distributed.
Genius PRP (Platelet Rich Plasma) System, 30mL Disposable Kit, Part No. 64000-05
JP s Delicacies LLC of Bloomfield NJ discovered during a walk thru of area stores,  bulging bottles of Holi Aioli, Lemon Basil, 12oz Bottle, expiration date of 7/18/18.  The firm has decided to initiated a recall because the products do not meet the firm s manufacturer standards.
Vista Information System P/N 25201, Vista Version 4.01
Terumo BCT's Vista Information System (version 4) with a defect or glitch on the Trima Accel Automated Blood Collection  System, was distributed.
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Plateletpheresis products, not meeting product specifications, were distributed.