Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL  61103.
a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL  61103.
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL  61103.
Worldwide distribution.  US nationwide including Puerto Rico;  Australia, Canada, New Zealand, and Japan
1) The HomeChoice automated peritoneal dialysis system.  Dataplate located on the device is labeled in part: Baxter.     2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter.    The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
*** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units
In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP).  This can cause serious problems in patients with unrelated a co-morbid condition of ascites.
*** 1) HomeChoice automated peritoneal dialysis system:   Product Codes: 5C4471 and 5C4471R;   Serial Numbers: All serial numbers;     *** 2) HomeChoice Pro automated peritoneal dialysis system:   Product Codes: 5C8310 and 5C8310R;   Serial Numbers: All serial numbers
LAXMI NUTKHHAT Golden Raisins, Net Wt. 200g (7 oz), Product of USA -- Distributed by House of Spice Flushing, NY
The product contained undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets
distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.
Wild Steelhead Salmon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC
any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.
Wild Steelhead Salmon - Custom Packed-NW Wild Products, 6.5 oz. metal cans.  No UPC
All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.
Columbia River Chinook Salmon -Custom Smoked, NW Wild Products, 6.5 oz. metal cans.  No UPC
Oregon Sardines - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC
Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6.5 oz. metal cans.  No UPC
Wild Columbia River Coho Salmon- Custom Smoked, NW Wild Products, 6.5 oz. metal cans.  No UPC
Pacific White Albacore Tuna - Custom Packed -NW Wild Products, 6.5 oz. metal cans.  No UPC
Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans.  No UPC
Pacific Black Cod- Custom Smoked -NW Wild Products, 6.5 oz. metal cans.  No UPC
Oregon Sardines - Mustard-NW Wild Products, 6.5 oz. metal cans.  No UPC
Wild Northwest Razor Clams - Custom Packed-NW Wild Products, 6.5 oz. metal cans.  No UPC
Wild Columbia River Coho Salmon- Custom Packed, NW Wild Products, 6.5 oz. metal cans.  No UPC
Oregon Sardines -  Spicy Tomato-NW Wild Products, 6.5 oz. metal cans.  No UPC
Wild Columbia River Sturgeon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC
Wild Northwest Razor Clams - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC
Columbia River Chinook Salmon -Custom Packed, NW Wild Products, 6.5 oz. metal cans.  No UPC
AL, AZ, AR, CA, CO, CT, FL, GA, HI, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, & Puerto Rico
Ivomec (Ivermectin) Injection for Cattle and Swine 1% Sterile Solution, 50 mL, Distributed by Merial Limited, Duluth, GA 30096, Product 67306; Ivomet (Ivermectin) Injection for Cattle and Swine 1% Sterile Solution, 500 mL, Distributed by Merial Limited, Duluth, GA 30096, Product 67308
Out-of-specification (OOS) assay value for the 12 month, 25C/60% RH, ongoing stability sample of Ivomec (Ivermectin 1%) Injection.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Eatin' Alive VEGAN GLUTEN FREE RAW thai wrap.  Keep Refrigerated.  6oz  UPC 0 91037 56620
Paige Common dba Eatin' Alive is recalling Thai Peanut Noodles and Thai Wrap due to undeclared allergen soy.  The soy is a sub ingredient of tamari.
Eatin' Alive VEGAN GLUTEN FREE RAW thai peanut noodles.  Keep Refrigerated.  8oz  UPC 0 91037 56624 9
Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Beginning Lot Code 141001X with Ending Lot Code 20150705X.
English Bay Batter Inc (Toronto) US Division
Product was shipped to New York only and then redistributed by the consignee to Connecticut, Massachusetts, Pennsylvania, Vermont, New Hampshire. No government accounts, no Canadian or Mexican accounts and no other foreign accounts.
CINNAMON ROLLS WITH CREAM CHEESE ICING Quality & Value pics BY PRICE CHOPPER NET WT 12.4 OZ (351g) INGREDIENTS: ***CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURES***. CONTAINS WHEAT. MAY CONTAIN MILK, EGGS, SOY, PEANUTS AND TREE NUTS. DISTRIBUTED BY: PRICE CHOPPER, INC. SCHENECTADY, NY 12306 UPC 0 41735 07338 9.
, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
Neff DAgostino Percutaneous Access Set  Accessories, Catheter  Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
All Lots.  Catalog/product number; Global/order number  NPAS-100-DAgostino-B-050393          G08403
Haskal Transjugular Intrahepatic Portal Access Set  Introducer, catheter  Intended for transjugular liver access in diagnostic and interventional procedures.
All Lots.  Catalog/product number; Global/order number  HTPS-100	G36126
All Lots.  Catalog/product number; Global/order number  J-RTAS-100	G51608
All Lots.  Catalog/product number; Global/order number  J-SSG-504000	G17868
Access Nonvascular Introducer Set  Accessories, Catheter  Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
All Lots.  Catalog prefixes / suffixes NPAS-/-SST    Catalog/product number; Global/order number  NPAS-100-HC-NT-U-SST	G52963  NPAS-100-HC-U-SST   	G52962  NPAS-101-HC-NT-U-SST	G23067  NPAS-101-HC-U-SST   	G23066  NPAS-104-HC-NT-JWG-U-SST	G52966  NPAS-104-HC-NT-U-SST	G52965  NPAS-104-HC-U-SST   	G52964  NPAS-105-HC-NT-U-SST	G52967  NPAS-108-HC-NT-U-SST	G25516  NPAS-120-HC-NT-U-SST	G25517  NSSW-4.0-18-NPAS-100-HC-SST	G34253
Transluminal Biliary Biopsy Forceps Set  Forceps, Biopsy, Non-Electric  Intended for access to and biopsy of tissue within the biliary ductal system
All Lots.  Catalog/product number; Global/order number  BBFS-100   	G26088
Liver Access and Biopsy Needle Set  Biopsy needle kit  Intended for use in obtaining liver histology samples via a jugular vein approach.
All Lots.  Catalog prefixes LABS    Catalog/product number; Global/order number  LABS-100   	G08283  LABS-200	                      G08284  LABS-200-CHP-A	G10590
All Lots.  Catalog/product number; Global/order number  023565-BT 	G18074
All Lots.  Catalog/product number; Global/order number  LMGRF-7.0C-80-MPA-PULM	G11164
US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.
Ziehm Vision RFD Mot,  Mobile C-arm for Mobile Fluoroscopic Imaging
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
Ziehm Vision RFD,  Mobile C-arm for Mobile Fluoroscopic Imaging
Ziehm Solo,  Mobile C-arm for Mobile Fluoroscopic Imaging
Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Ziehm Vision2,   Mobile C-arm for Mobile Fluoroscopic Imaging
US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics.    Product Usage:  RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Haemonetics Leukotrap RC System with RC2D Filter  Haemonetics Anticoagulant Citrate Phosphate Triple Dextrose (CP2D & Additive Solution 3 (AS-3), 500 ml  Reorder # 129-63
All lots of Haemonetics Corporation Leukotrap RC System with RC2D Filter (Re-Order Numbers 129-62 & 129-63) with reports of higher than expected residual white blood cells, were distributed.
Haemonetics Leukotrap RC System with RC2D Filter  Anticoagulant Citrate Phosphate Double Dextrose (CP2D & Additive Solution 3 (AS-3), 500 ml  Reorder #129-62
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz  (142 g) and b) 9.0 oz  (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ.  Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Crystallization; Complaints that cream appears to have crystallized
Nabisco Honey Maid Teddy Grahams Cinnamon  Cubs Graham Snacks Net Wt .5 oz (14g) Distributed by Mondelez Global LL East Hanover, NJ 07936 USA  UPC 019320016769
Teddy Graham Cub Snacks were produced using Grain Craft Flour containing peanut residue.
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Superpotent drug: Out of specification test result for assay during stability testing.
US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers.  During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
DBS Pocket Adaptor, Model 64001 and Model 64002.    The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.
7,542 in the US and 12,999 outside the US.
Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.
Worldwide distribution.  US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177.    Used with vascular catheter.    Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
8,750 devices were distributed in commerce
Potential coating contamination with glass particles.
Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Product distributed in US.    The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom.    No product was distributed to US government accounts.
Radiotherapy Delivery System, K140528.  The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS].  1. CRM 3194, No Serious Injury, No MDR, Aware date:  Dec 11, 2015    2. CRM 3321, No Patient Involved, No MDR, Aware date:  Jan 19, 2016  3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016	  No patient harm was reported in any of these cases.
distributed nationwide and also sold to internet customers from the company website: montanaflour.com
100% Organic Spelt Grain,  packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
Organic Spelt Grain is recalled because label does not declare wheat.
100% Organic Unbleached White Flour,  packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
Organic Unbleached White Flour is recalled because label does not declare wheat.
codes:    UWFAA55317F  UWFAA55317F  UWFAA56043F  UWFAA56112F  UWFGC26033F  UWFGC26096F  UWFGC26112F  UWFGD16043F  UWFGD26112F
100% Organic Spelt Flour,  packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
Organic Spelt Flour is recalled because label does not declare wheat.
lot codes:    SPFGD26099F  SPFGC26096F  SPFGC26033F  SPFGC20646F  SPFGC20626F  SPFDA56099F  SPFDA56089F  SPFDA26048F  SPFCA56032F  SPFBA56160F  SPFBA55365F
The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial Flavored, Net WT 5.0 OZ (142 g), UPC 7 63913 13003 4.
Northern Tier Bakery LLC is recalling Pleasant Hill Ovens Cheese & Berries Danish  pastries  for possible mislabeling and undeclared colors Blue #1 and Red #40.
U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the  impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922
Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.
Alere INRatio Replacement Monitor  Model Number: 0100137     Usage:  The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.
Alere INRatio2 PT/INR Professional Testing System  Model Number: 0200431    Product Usage:  The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.
INRatio Prothrombin Time (PT) Monitoring System  Model Number: 0100007     Product Usage:  The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that cause coagulation to begin. The test strip area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the Prothrombin time test on the blood sample. The other two channels contain the reagents. to perfom the Prothrombin time test on the blood sample. The other two channels contain the reagents to run control tests. No external quality control test are required for the INRatio System. The meter monitors the reactions, and calculates the PT and INR for the blood sample, which are reported on the display. If the control results are not within a set range, it indicates a problem with the test and an error message is reported on the display instead of a result.
Alere INRatio PT/INR Test Strips  Model Number: 0100071, 0100139    Product Usage:  The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.
Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000.    Use with alternating pressure air flotation mattress.
The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.
Serial No. 9500051 sequential to 9500300.
Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Crystallization; complaints received by the manufacturer of crystals forming in product
Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu,  (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy,  San Antonio, TX 78247
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy,  San Antonio, TX 78247
U.S. distribution to the following; CA, OR, IL, SC, IN.  No foreign distribution.
Agave Dream Cappuccino Ice Cream  Pint  UPC code: 899349002048
Stryker Instruments Div. of Stryker Corporation
Domestic:MI, CA, ID, IA    VA/DOD: None  Foreign: None
120 V Neptune 3 Rover, Model Number: 0703-001-000
Stryker  initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.
Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
BVX-450BR Bovie Precise 360 Handpiece 45cm, blade   Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
BVX-330NR Bovie Precise 360 Handpiece 33cm, needle     Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
BVX-330BR Bovie Precise 360 Handpiece 33cm, blade     Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle     Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
la Torre Copito Marshmallow Chocolate Cookie NET WT 4.94 oz packaged in a cardboard box.
Calcium caseinate is declared on the label, but milk is not listed.
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only,  Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Cobalt HV Bone Cement    Product Usage:  Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
.  The bone cement does not contain antibiotics.
US : IL, CA, FL, KY, MO, NH, VA, TX, NC, OH, NY, TN,   Worldwide:  Sweden, Italy, Denmark, UK, Singapore, Germany, Belgium, Spain, Austria, Israel, Malta, Switzerland, Ireland, Norway, Netherlands, Turkey, New Zealand, Bulgaria, France, Iran, Finland, Poland, South Africa
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
Infinite F50 instrument.  The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
The batteries have the potential to overheating, melt or char.
Instrument Material #330087508, PC Serial # CND5219H07, Instrument Serial #1508007738.
Hydroflex ELISA  The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for other areas of application not mentioned in the Intended Use (e.g. veterinary, biopharma).
Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.
Tecan Infinite 200.  The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics.
Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940; PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.
Infinite 200 PRO  The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940: PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.
SUNRISE instrument.  The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116; PC Serial #2CE3461RV1, Instrument Serial #1404001455; PC Serial #2CE3461RVY, Instrument Serial #1404001456; PC Serial #2CE41503MD, Instrument Serial #1405003467; PC Serial #2CE3462FX0, Instrument Serial #1405002373; PC Serial #2CE4220BW9, Instrument Serial #1407000866; PC Serial #2CE42406XP, Instrument Serial #1409007597; PC Serial #CND4426259, Instrument Serial #1412005606; PC Serial #CND442618S, Instrument Serial #1503003902; PC Serial #CND44261R2, Instrument Serial #1504007122; PC Serial #CND44273XJ, Instrument Serial #1504004857; PC Serial #CND5219GYY, Instrument Serial #1506006286; PC Serial #CND5219GYX, Instrument Serial #1509005071; PC Serial #CND5219H21, Instrument Serial #1511009478; PC Serial #CND5219GYN, Instrument Serial #1512005969; PC Serial #CND5219H68, Instrument Serial #1603000018; PC Serial #CND5219GYJ, Instrument Serial #1606001277 and PC Serial #CND5219GZW, Instrument Serial #1606001263.
Tecan Infinite M1000  The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards
Instrument Material #30034301, PC Serial number: 2CE33625NS, Instrument Serial #1508007738.
Tecan Infinite M1000 PRO  The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards.
Instrument Material #30063849, PC Serial # 2CE3362609, Instrument Serial #1110008219; PC Serial # CND5219H33, Instrument Serial #1204007588;  PC Serial # 2CE3462FTJ, Instrument Serial #1301009861; PC Serial # 2CE3462FTD, Instrument Serial #1311007574; PC Serial #2CE33625KP, Instrument Serial #1404000703; PC Serial #2CE33625ND, Instrument Serial #1404000704; PC Serial #2CE41503PY, Instrument Serial #1406000407; PC Serial #2CE41503NW, Instrument Serial #1408001415; PC Serial #2CE41503K0, Instrument Serial #1407003406; PC Serial #CND5219GY7, Instrument Serial #1509001006 and PC Serial #CND44273YB, Instrument Serial #1604003735.
OEC UroView 2800, fluoroscopic x-ray system
A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
Brilliance CT 16 Power, Model number 728240    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Brilliance 64 CT Model number 728231    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance BigBore Radiology CT Model number 728244    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance 16, Model number 728246    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core, Model number 728321    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance CT Big Bore Oncology, Model number 728243    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core128, Model number 728323    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Total of 336 containers for all products
The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.
Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)
OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114174; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
SOMATOM Definition AS with software version VA48A-SP2;   Model # 10430603, computed tomography x-ray system
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved.  This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
SOMATOM Definition Edge  with software version VA48A-SP2; Model # 8098027  computed tomography x-ray system
RESPONSIVE, KNEE:  FEMORAL COMPONENT CR/CS, SIZE 3R,  REF 90-SRK-311300, QTY:  1, STERILE R,
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
TIBIAL TRAY , SIZE 2,  REF 90-SRK-200200, QTY:  1, STERILE R, total knee replacement .
RESPONSIVE, KNEE:  FEMORAL  total knee replacement COMPONENT CR/CS, SIZE 4R,  REF 90-SRK-311400, QTY:  1, STERILE R,
TIBIAL TRAY , SIZE 5,  REF 90-SRK-200500, QTY:  1, STERILE R, Responsive Orthopedics, total knee replacement
TIBIAL TRAY , SIZE 4,  REF 90-SRK-200400, QTY:  1, STERILE R, Responsive Orthopedics, total knee replacement
RESPONSIVE, KNEE:  FEMORAL total knee replacement   COMPONENT CR/CS, SIZE 5R,  REF 90-SRK-311500, QTY:  1, STERILE R,
TIBIAL TRAY , SIZE 3,  REF 90-SRK-200300, QTY:  1, STERILE R, total knee replacement
RESPONSIVE, KNEE:  FEMORAL total knee replacement COMPONENT CR/CS, SIZE  3L,  REF 90-SRK-312300, QTY:  1, STERILE R,
US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only,     Product Usage:  The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA.  Government distribution was made to OK.  There was no foreign/military distribution.
RadSuite software.  The firm name on the label is Merge Healthcare, Hartland, WI.
25 sites potentially have the affected versions
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.
Medtronic Inc., Cardiac Rhythm and Heart Failure
Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.
Medtronic, Evera Implantable Cardioverter Defibrillators:    Product       Model  EVERA XT   DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1.  EVERA S     DDBC3D1, DDBC3D4    Product Usage:  The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only).
78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
Worldwide Distribution - US (Nationwide) Canada and other foreign consignees.
Blood Bank Of San Bernardino And Riverside Counties
Blood products, lacking assurance of proper leukoreduction, were distributed.