Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.
Part Number 04175-0008 and Part Number 13-00106-00
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole.   --- CDRH Classification Name: Nebulizer (Direct Patient Interface)
Lot Number J0571670RA*/Serial Number 337170600007;  Lot Number J0571670R*/Serial Number 337170600007;  Lot Number J0571670/Serial Number 337170600007;  Lot Number L0197340/Serial Number 340150600003;  Lot Number K1900650/Serial Number 340150600003.
Intellicuff Standalone (PN 951001)    Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL
Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS  Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; Manufactured by PharmaTech LLC, Davie, FL
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL
US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV
Unifine Pentips 5mm x 31G pen needles, packaged in  30 ct pen needles.    Product Usage:  Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility.  This may appear as discoloring or yellowing of the device's protective seal.
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles.    Product Usage:  Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2     TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM,  LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2     TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2     TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2     TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2     TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2     TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2     TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12,  Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304.
Domestic: IL, WI    Foreign: None  VA/DOD: None
Jalebi, .5-1 lb. Clear Plastic clamshell containers
New Punjab Sweets, Inc.is initiating a voluntary recall of multiple products due to undeclared allergens wheat and milk.
No codes are available; no lot numbers, no expiration dates
Gur Para 1 lb. clear plastic clamshell containers.
Badusha, 1 lb. clear plastic clamshell containers.
Besan Burfi, 1 lb. clear plastic clamshell containers.
Namak Para 1 lb. clear plastic clamshell containers.
Mixed Sweets- variety 1 lb. clear plastic clamshell containers.
Besan Ladoo, 1 lb. clear plastic clamshell containers.
Laddu, 1 lb. clear plastic clamshell containers.
Sakkar Para, 1 lb. clear plastic clamshell containers.
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL)  in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
Philips Electronics North  America Corporation
1067 US customers  163 Canada, 917 International
ECG Out Cable  -  Heartstart MRx  M1783A/M5526A 12-pin Sync cables  All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641.  Manufactured - September 4, 2002   October 8, 2014
On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*.     *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning:  When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+.  If the user follows this warning, this problem cannot occur on the XL+.
M1783A/M5526A 12-pin Sync cables    All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
A&W All American Food Papa Sauce; 8/24 OZ. Pouches; Net Wt 12 LB. Paced Exclusively For Use By: A&W and its franchisees., Lexington, KY 40611; Use by: 04 29 18 and 04 30 18;
A plastic foreign object was inadvertently introduced into the product stream. The firm is recalling product as not all plastic has been accounted.
plastic cup with foil seal:  House Recipe Ranch Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Code:  B10127;    packed in cardboard case :  House Recipe; Distributed By Sysco Corporation; Houston Texas  77077; B10127; HR Rch 128/1.5 oz; 3060371; 20793SYS;
Gordon Choice Honey Mustard Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ; Code: 33217.;  Honey Mustard Dressing; Keep refrigerated; Net Content 1 Gallon; Ventura Foods, Brea, CA 92821, dtd: 053018; Sysco Reliance Honey Mustard Dressing Dijon; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Lot codes: B12817; Sysco Classic Dijon Style Honey Mustard Dressing & Dip; Net Contents 3.78 L; Prepared For Sysco Corporation, Toronto, Canada; Lot codes: B12817
Gordon: 52, 4 - 1 gal/cs.; Ventura: 192, 4-1 gal/cs. Reliance: 15, 2-1 gal/cs.;  Classic: 15, 2-3.78L/cs.
Sysco Imperial Tartar Sauce; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas  77077;  Code: 12817;       Classic Gourmet Dressings Select Tartar Sauce; Net Contents 1 Gal.; Ventura Foods, Brea, CA 92821; Code 05 30 18;  .    Culinary Secrets Deluxe Tartar Sauce; Net Contents 1 GAL; Marketed By Independent Marketing Alliance, Houston, TX 77079; Coded: 10127 ;
Imperial: 110, 4-1 gal/cs.; Classic Gourmet: 15, 4-1 gal/cs; Culinary Secrets: 6, 4 -1 gal/cs.
Imperial:  Code: 12817;    lot date 11/28/2017  Classic Gourmet: Code 05 30 18;    Culinary Secrets: Coded: 10127;   lot date 12/1/2017
Sysco Imperial Glazed Hot Bacon Dressing; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas  77077; Code: B12917
Single-serve plastic packet Italian Dressing;  Case packing:  Sysco Classic  Cls Italian 500 12Gm ; 47014SYS; B13017;  single-serve plastic packet: Chef's Quality Creamy Italian;   Chef's Quality; 60/1.5 OZ Pouches Net Wt 5.6 LB; 16689CHQ, B33317;
Smokehouse 220 Sweet & Spicy Barbecue Sauce; Net Wt. 16 OZ.; Ventura Foods, Brea, CA  92823; Coded: 05 30 18.
Single-serve plastic pack:  Newman's Own Lite Sesame Ginger; Net Wt. 1.5 OZ.;  Produced exclusively for Newman's Own, Inc., Westport CT  06880    Carton:  Newman's Own, Inc., Westport  CT  06880; 100/1.5 OZ; Lite Sesame Ginger, code: 042918
Classic Gourmet Dressing; Country French; Net Wt 1.5 OZ.; Ventura Foods, LLC, Lot codes: 33317; Culinary Secrets Country French Dressing; Net Wt. 1.5 OZ.; Lot Codes: 04 29 18; Sysco Reliance French Style Dressing; Net Contents 1 GAL; Lot codes: B12817; Gordon Choice California-Style Red French Dressing; Net Contents 128 FL OZ; Code: B33217;Gordon Choice California-Style Red French Dressing; Net Contents 128 FL OZ; Code: B33217; Bulk single serve- foodservice Packet: French Dressing; Case: Classic Sysco; Cls French 500 12GM; B13017, 47008SYS; Classic Gourmet Dressings Bistro Creamy French, Net Contents 1 Gal; Lot Codes: B12871; Sysco Reliance French Style Dressing; Net Contents 1 GAL; Lot codes: B12817; Classic Gourmet Dressings, Select, Kahlena French-Style; Net Contents 1 Gal; Codes: B1291, B12917, B12817
plastic cup with foil seal:  House Recipe Bleu Cheese Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Code:  B10127;    packed in cardboard case :  House Recipe; Distributed By Sysco Corporation; Houston Texas  77077; B10127; HR BluChs 128/1.5 oz; 3060413; 20789SYS;
Rio Pacific Foods Deluxe BBQ Sauce; 3.78 litre; Produced in the USA for Funnybones Foodservice Ltd, Hertfordshire AL7 1HW; Lot #120117
Gordon Choice Thousand Island Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ; Code: B33217.
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI.      Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
Persona Partial Knee System, Size 8, Finishing Guide
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Blood and Blood Products for Reprocessing
Blood product, in which donor suitability was not adequately determined, was distributed.
American National Red Cross, Penn Jersey Region
Apheresis products for which white blood cell count testing was not performed, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
The American National Red Cross - Southern Region
College Business & Technology Park; Blanchardstown Road North
Raplixa Delivery Kit, not meeting labeling claims, were distributed.
Product Codes:    DEMOPF009, PF009, SAPF009
Phadia 1000 Instrument, Article Number 12-3800-01.
command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
Affirm Lateral Arm Upright Biopsy Accessory. Product Number:	ASY-09880
CM1517, CM1617, CM1717, CM1817, CM1917, CM2017, CO2117, CM2217, CM2317, and CM2417.    The codes are interpreted as:    CM = Chum Salmon  CO = Coho Salmon    first and second digit = sequential batch number of the year.  third and fourth digit = calendar year 2017.
The product was distributed thru out the United States. AL, AR, CA, CT, FL, GA, PA, OH, NJ, NY,IA,  ID, IL, SC, MD, MT, IN, NH, MI, NC, MN, SD, WA, VA,
Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz  (48 g) and   NET WT. 3-1/2 OZ (98 g) 25 Count
Gel Spice, Inc. is recalling three beef flavored bouillon cube products because they contain undeclared allergens --  soy and wheat.
Product was distributed nationwide in the USA.
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico  Worldwide
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Model's;  L210, L211, and L231  - NOT APPROVED IN US
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products for which quality control procedures were not performed, were distributed.
US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
Platelet products, in which platelet yield did not meet specifications, were distributed.
Product was shipped to CA, MN, OH, TX & WA.
Michelina's Fettuccine Alfredo NET WT. 8.5 oz package Frozen CONTAINS MILK, WHEAT BELLISIO FOODS, INC., DULUTH, MN 55802 UPC 7 17854 10501 9
455 cs/12/8.5 oz packages - total: 5460 entrees
Undeclared soy. Firm was notified by a consumer that they found chicken in the product. The chicken contains soy.
PRODUCT IDENTIFICATION CODE J7305D16 BEST BY 01NOV2018
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Presence of foreign substance: metallic razor blade was found in one bottle.
U.S. distribution to the following: NY, CA    Foreign distribution to the following: Canada
Polly Ann  Mango  Ice Cream Bar  4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL)  UPC 7 00730 28866 1
Polly Ann  Green Bean  Ice Cream Bar  4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL)  UPC 7 00730 26666 9
Polly Ann  Red Bean  Ice Cream Bar  4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL)  UPC 7 00730 26868 7
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows:  (a) Shoulder Arthroscopy Pack 89-8686.01  (b) Shoulder Arthroscopy Pack 89-8686.02  (c) Knee Arthro Pack 89-8687.01  (d) Knee Arthro Pack 89-8687.02    Product Usage: general surgical
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
U.S. distribution to the following: CA., WA, TX, CO, HI, IL.    No foreign distribution.
Hanryosued (F. Dashi Anchovy)  1.5kg x pack/carton  UPC 826546102745, 826546102378
Un-eviscerated and/or partially eviscerated dried fish.
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom.    4 in US, (1 military), 14 foreign accounts
Ingenuity Core, (Code 728321)    Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Brilliance 64, (Code 728231)    Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Brilliance iCT    Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Ingenuity Core 128, (Code 728323)    Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Old Fashioned Coconut Bon Bons; Net Wt. 6.5 OZ. (184g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 6.5 oz. clear plastic tubs with clear plastic lids.
An intermittent ingredient statement labeling error by the firm's label printing company led to the firm's Pecan Divinity products being mislabeled with the ingredients for its Coconut Bon Bon products.  Also, the firm's Coconut Bon Bon products were intermittently mislabeled with the ingredients for the firm's Pecan Divinity products.  The intermittent labeling errors led to the undeclared allergen of pecans in the ingredient statement of the Pecan Divinity products and the undeclared allergen of coconut in ingredient statement of the Coconut Bon Bon products.
UPC Code 041466031238  Lot numbers:   11577 Expiration Date 2/06/18;  11917 Expiration Date 3/10/18;    12597 Expiration Date 5/16/18;  12777 Expiration Date 6/04/18;  12987 Expiration Date 6/25/18; and  13187 Expiration Date 7/14/18
Old Fashioned Pecan Divinity; Net Wt. 8 OZ. (226g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 8 oz. clear plastic tubs with removable clear plastic lids.
UPC Code 041466031207; Lot number 13007 with Expiration Date 3/27/18; and Lot number 13327 Expiration with Date 4/28/18
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
CA, IL, CO, TX, WA, MA, FL, PA, WA, OR, OH,
Coconut Tree Brand Shredded Coconut; frozen  Dua Bao;  Net WT. 16 oz. (454 g); Product of Vietnam;  UPC 05216-44081    Ingredient: Coconut  Manufactured by:  Lucky Shing Co., LTD  108/1 Road No. 830, Hamlet No. 3  An Thanh Village, Ben Luc District  Long An Province, Vietnam.
State of Massachusetts tested product and found it to be positive for Salmonella
All lots, item number 331233    Affected lot number is SE07A1; however that number is only on the outer case and not on individual bags.
Sold to distributors in: MA, IL, CA, PR, CA, FL, MN, IL, OH, CT, MI, MO. Product was distributed nationwide including Puerto Rico.
Chocolate Covered Vanilla Ice Cream Bars packaged under the following brands: 12 packs - Ahold  UPC: 6 88267 03323 5 and different ICB: 6 88267 08587 1, Econo  UPC: 7 08938 00534 9, First Street  UPC: 0 41512 11933 0, Food Club  UPC: 0 36800 78404 8, Giant Eagle  UPC: 0 30034 00329 6, Great Value  UPC: 0 78742 09158 7, Greens  UPC: 0 71441 03131 1, Hagan no ICBs, Hood  UPC: 0 44100 23704 1, Kroger  UPC: 0 11110 57120 5 and Kroger NFA ICBs  UPC: 0 11110 57885 3, Lucerne  UPC: 0 21130 09799 9, Market Basket  UPC: 0 49705 96902 1, Party Treat No ICBs, PIC  no product of ours, Polar Express  Only Variety pack, Price Chopper  UPC: 0 41735 09260 1, Price Rite  UPC: 0 41190 75712 1, Purple Cow  UPC: 7 08820 42754 9, Shoprite  UPC: 0 41190 40126 0, Southern Home  UPC: 6 07880 01147 0, , Stater  UPC: 0 74175 85045 6, Stoneridge  UPC: 0 41130 61333 3, Sundae Shoppe  UPC: 0 41498 17991 5, Tops  UPC: 0 70784 04912 0, United Dairy  UPC: 0 71580 08079 9, Weis  UPC: 0 41497 01042 4, Wellsley Farms   Only Variety pack, Winn Dixie  UPC: 0 21140 27145 7, World s Fair  UPC: 0 51933 67170 6
Product may be contaminated with Listeria monocytogenes.
The recalled products have a production date of January 1, 2017 to December 31, 2017 and a best by date of January 1, 2018 to December 31, 2018. The Hood and Kemps products may show a best by date of July 1, 2018 to June 30, 2019.
Ice Cream Variety Packs containing Sandwiches, Bars, and Cones, Sold under the following: 30 pack - pics BY PRICE CHOPPER - UPC: 041735080295; STARTER BROS Ice Cream Favorites Variety Pack, UPC: 074175850111; WELLSLEY FARMS ICE CREAM TREATS VARIETY PACK, UPC: 888670020487; STONE RIDGE CREAMERY CLASSIC VARIETY PACK, UPC: 041130614330; POLAR EXPRESS ICE CREAM COMPANY Variety Pack, UPC: 071632613692; GIANT EAGLE Variety Pack, UPC: 030034065676; Food Club VARIETY PACK, UPC: 036800415249; FIRST STREET Ice Cream Variety Pack, UPC: 041512138690 and 32 pack - weis quality ice cream variety pack, UPC: 041497010554
Orange Cream Ice Cream Bars sold under the following labels: Sold in a 12-pack: Ahold   UPC: 6 88267 03292 9, Econo   UPC: 7 08938 00610 0, First Street   no OCB s, Food Club   UPC: 7 08938 00610 0, Giant Eagle   UPC: 0 30034 00337 1, Great Value  no OCB s, Greens UPC: 0 71441 03130 4, Hagan   UPC: 0 37498 01609 1, Hood   UPC: 0 44100 23138 4, Kemps   UPC: 0 41483 03806 7, Kroger   UPC: 0 11110 57028 4, Lucerne   UPC: 0 21130 09796 8, Market Basket   UPC: 0 49705 96901 4, PIC - no product of ours, Polar Express    Only Variety pack, Price Rite   UOPC: 0 41190 75722 0, Price Chopper   UPC: 0 41735 09372 1, Purple Cow   UPC: 7 08820 42753 2, Shoprite   UPC: 0 41190 40125 3, Southern Home   UPC: 6 07880 01142 5, Stater   UPC: 0 74175 85013 5, Stoneridge   UPC: 0 41130 61419 4, Sundae Shoppe   UPC: 0 41498 8642 5, Tops   UPC: 0 70784 04916 8, United Dairy   UPS: 0 71580 08092 8, Weis   UPC: 0 41497 01108 7, Wellsley Farms   Only Variety pack, Winn Dixie   no OCB s, Worlds Fair   UPC: 0 51933 06140 8 and sold in a 3 pack - Party Treat   UPC: 0 71632 00235 9
The recalled products have a production date of January 1, 2017 to December 31, 2017 and a  best by  date of January 1, 2018 to December 31, 2018. The Hood and Kemps products may show a  best by  date of July 1, 2018 to June 30, 2019.
RASPBERRY Cream Ice Cream Bars: Sundae SHOPPE, 12 Bars, UPC  041498204631
The recalled products have a production date of May 2017 to August 2017 and a best by date of May 2018 to August 2018.
Product was distributed to S.E. Meats in Birmingham, AL.
Seasoning Blend- S.E. Meats (Diced red peppers, green peppers, celery and onions) Net weight 1300 LB in TOTE (Plastic liner, corrugated totes)
32,028 lbs in 1300 LB in TOTE (Plastic liner, corrugated totes)
The product has been recalled because it has the potential to be contaminated with a chemical pesticide residue.
US Distribution and Internationally to Mexico.
ASPIRE Cristalle (FDR MS-3500)  Mammography machine    The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F  and Aspire HD-s (FDR MS-2000),   also known as Aspire HD Plus S).  Mammography machine    The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
FDR MS-2500 made in Japan : S/N- 16640001 or later   FDR MS-2500 made in China : S/N- 26860001 or later   FDR MS-2000 made in Japan : S/N- 16650001 or later   FDR MS-2000 made in China :  S/N- 26870001 or later
CA, VA, TN, LA, MD, GA, TX, KY, NC, WA, CO, IL,  PA, WI, AZ, SC, UT, MI, MA, NY, MO, NJ, WV, OR, KS, IN, RI, OH, MA, IN, NM, ID, TN, NE, NV, FL, NY,
Frozen Tuna Fillet Saku (Restaurant Supply Only);  22 lbs./2 x 5 kgs.  Wild caught: Handline with Hook.    Keep Frozen - 18 degrees C or below  Product of Indonesia;  Packed for H.I.G. Corporation. Carson, CA
Customer tested product and found Listeria monocytogenes in frozen tuna fillet saku
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
RayStation     Product Usage:  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.
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01.    The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
Labeling: Not Elsewhere Classified: Mitomycin 40 mg/10 mL labeled incorrectly as Mitomycin 40 mg/mL.