Worldwide Distribution.  US nationwide, including Puerto Rico, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam & Yemen.
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0.  Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Multiple software defects which could impact the performance or reliability of the system.  These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images.  There is a risk of misdiagnosis.
Worldwide distribution, including US states of CA and NV.
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243.   software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets.  this causes information regarding relative locations of marked regions of interest on the patient  work sheets to be incorrect and may cause mistreatment.
Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX  866024 PIIC iX Upgrade  866117 PIIC Classic Upgrade    The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location.     An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Software systems Revision A.02.05 or lower
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
The eCareManager system.  Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
eCareManager v3.7, 3.7.1, v3.8, and v3.9
A software defect may cause incorrect medication order change.  If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list.  At the stage where the order is signed, the medication displayed may be incorrect.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Taco de Camarn con Imitacin de King Crab (Shrimp with Imitation King Crab Taco). Label reads in part :  '' *** Soto Fabrica & Confecciones''*** Tacos de Camarones*** Mantenganse Congelado''*** Peso Neto 5 lbs(2.3 kg)*** Manufacturado por: Fabrica Confecciones Soto, Inc. calle Autonomia #81 Canovanas, PR 00729***''
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Valeant Pharmaceuticals North America LLC
AL, AZ, CA, CO, IL, OH,  MO, NC, NY, PA., SC, UT and TX
Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
No Foreign Consignees No VA or DoD Consignees.  Distributed to Michigan, Nevada, Oregon, and Washington and sold to internet customers nationwide from the website skipanonbrand.com.
Albacore Tuna in gold pouches with stick-on label reading in part:  ***SKIPANON BRAND SEAFOOD ALBACORE TUNA***INGREDIENTS:  Albacore Tuna, Sea Salt.  NET WT. 48 OZ. ***'' UPC:  58071 00148  Code on pouch beginning with OCK TUNA 3#.  Label has green, yellow and blue background with multiple color lettering.    Canned Albacore Tuna with paper label reading in part:  ***SKIPANON BRAND SEAFOOD ALBACORE TUNA***Ingredients:  Albacore Tuna, Sea Salt.  NET WT. 66.5 OZ. (1885g)***''   UPC:  58071 00144  Can code beginning with OCK.  Label has a yellow background and a blue strip on the bottom.  Lettering is in multiple colors.    Canned Albacore Tuna with paper label reading in part:  ***SKIPANON BRAND SEAFOOD ALBACORE TUNA***INGREDIENTS:  Albacore Tuna, Sea Salt.  NET WT. 6 OZ. (170g)***''   UPC:  58071 00117  Can code beginning with OCK.  Label has a yellow background and a blue strip on the bottom.  Lettering is in multiple colors.    Canned Albacore Tuna 6oz, 7oz, and 64oz cans without labeling, salt added, distributed as brites.  Can code beginning with OCK.
All cans and pouches of Skipanon Brand seafood, including  tuna products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Chinook Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD CHINOOK SALMON***Ingredients:  Chinook Salmon, Sea Salt NET WT. 6 OZ. (170g)***''    UPC:  58071 00118  Can code beginning with OCCR.    Label background is yellow with a brown stripe at the bottom and multiple colored ink lettering.    Chinook (aka King) Salmon with salt added, canned and distributed as brites in 6oz cans.  Can code beginning with OCCR.
All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Label reads in part ''***SKIPANON BRAND SEAFOOD SMOKED ALBACORE TUNA***INGREDIENTS:  Albacore Tuna, Sea Salt, Brown Sugar, Natural Hardwood Smoke.  NET WT. 5.5 OZ. (156g) ***''   UPC:  58071 00116  Can code beginning with OCKH.    Label background is yellow with a blue strip on the bottom and multiple colored ink lettering.    Smoked Albacore Tuna contains brown sugar, salt, and is smoked with hardwoods and distributed as brites in 5.5oz cans.  Can code beginning with OCKH.
All cans and pouches of Skipanon Brand seafood, including smoked tuna products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Smoked Peppered Chinook Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD Peppered SMOKED CHINOOK SALMON Ingredients:  Salmon, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke***Net wt. 5 1/2 oz. (156g)***''   UPC:  58071 00114   Can code beginning with OCCH.    Label background is yellow with brown stripe on the bottom and multiple colored ink lettering.  The word ''Peppered'' appears in a red bubble above the word Smoked.
All cans and pouches of Skipanon Brand seafood, including smoked peppered salmon products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Albacore Tuna Bellies with paper label reading in part:  ***SKIPANON BRAND SEAFOOD ALBACORE TUNA BELLIES or Ventresca***Ingredients:  Albacore Tuna Bellies, Sea Salt, Spanish Olive Oil***NET WT. 66.5 OZ. (1885g)***''    UPC:  58071 00145  Can code beginning with OCKB.      Label background is yellow with a blue stripe on the bottom and multiple colored ink lettering.
All cans and pouches of Skipanon Brand seafood, including  tuna bellies products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Coho Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD COHO SALMON***Ingredients:  Coho Salmon, Sea Salt  NET WT. 6 OZ. (170g)***'' UPC:  58071 00119  Can code beginning with OCO.    Label has a yellow background with a gray line on the bottom, multiple colored ink is used for lettering.    Coho Salmon with salt added was distributed as brites in 6oz cans.  Can code beginning with OCO.
Canned Smoked Coho Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD SMOKED COHO SALMON***Ingredients:  Coho Salmon, Sea Salt, Brown Sugar, Natural Hardwood Smoke.  NET wt. 5.5 oz. (156g)***'' UPC:  58071 00113  Can code beginning with OCS.    Product label has a yellow background with a brown strip on the bottom and multiple colored ink for lettering.    Smoked Coho Salmon with brown sugar, salt, and smoked with hardwoods was distributed as brites in 6oz cans.  Can code beginning with OCS.
All cans and pouches of Skipanon Brand seafood, including smoked salmon products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Smoked Chinook Salmon with paper label reading in part:  ''***SKIPANON BRAND SEAFOOD SMOKED CHINOOK SALMON***Ingredients:  Salmon, Sea Salt, Brown Sugar Natural Hardwood Smoke. Net wt. 5 1/2 oz. (156g)***''   UPC:  58071 00112  Can code beginning with OCC.    Label has a yellow background with a red border on the bottom and multiple colored lettering.    Smoked Chinook (aka King) Salmon with brown sugar, salt and smoked with hardwoods was distributed as brites in 5.5oz cans.  Can code beginning with OCC.
COLUMBIA RIVER SOCKEYE (Old label) Canned Sockeye Salmon with paper label reading in part:  ***SKIPANON BRAND DELUXE HANDFILLED COLUMBIA RIVER SOCKEYE*** Ingredients:  Sockeye Salmon, Salt  NET WT. 6 OZ. (170g)***  UPC:  58071 00120    Label has green and yellow background with a red border and multiple colored ink lettering.      SOCKEYE SALMON (New label)   Canned Sockeye Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD SOCKEYE SALMON***Ingredients:  Sockeye Salmon, Sea  Salt.  NET wt. 6 oz. (170g)***''    UPC:  58071 00120  Can code beginning with OCBB    Label has a yellow background with  a blue/gray stripe on the bottom and multiple colored ink lettering.
Canned Smoked Sockeye Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD SMOKED SOCKEYE SALMON***Ingredients:  Sockeye Salmon, Sea Salt, Brown Sugar, Natural Hardwood Smoke.  NET wt. 5.5 oz. (170g)***''    UPC:  58071 00140  Can code beginning with OCB.    Label has a yellow background with a gray stripe at the bottom and multiple colored lettering.    Smoked Sockeye Salmon with brown sugar, salt and smoked with hardwoods was distributed as brites in 5.5oz cans.  Can code beginning with OCB.
Canned Steelhead with paper label reading in part:  ***SKIPANON BRAND SEAFOOD FANCY STEELHEAD***Ingredients:  Farm-Raised Steelhead, Sea Salt NET WT. 6 OZ. (170g)***''    UPC:  58071 00141  Can code beginning with OCST.    Label has a yellow background with a blue-gray stripe at the bottom and multiple colored lettering.
All cans and pouches of Skipanon Brand seafood, including steelhead trout products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Peppered Smoked Steelhead with paper label reading in part:  ***SKIPANON BRAND SEAFOOD Peppered SMOKED STEELHEAD***Ingredients:  Farm-Raised Steelhead, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke. Net WT. 5 1/2 oz. (156g)***''    UPC:  58071 00143  Can code beginning with OCSTH.    Label has a yellow background with a blue-green stripe at the bottom and multiple colored lettering.
All cans and pouches of Skipanon Brand seafood, including smoked steelhead trout products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Smoked Sturgeon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD SMOKED STURGEON***INGREDIENTS:  Sturgeon, Sea Salt, Brown Sugar Natural Hardwood Smoke.  NET WT. 5.5 OZ. (156g)***''  UPC:  58071 00111  Can code beginning with OCP.    Label has a yellow background with a green stripe at the bottom and multiple colored lettering.
All cans and pouches of Skipanon Brand seafood, including smoked sturgeon products are being recalled due to lack of documentation and possible under-processed product.  Under-processed seafood could lead to contamination with Clostridium botulinum.
Canned Sockeye Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD SOCKEYE SALMON***INGREDIENTS:  Sockeye Salmon, Sea Salt.  NET WT. 6 OZ. (170g)***''    UPC:  58071 00120  Code beginning with OCBB.    Label has a yellow background with a light green stripe at the bottom and multiple colored lettering.      Sockeye Salmon with salt added was distributed as brites in 6oz cans.  Code beginning with OCBB.
Canned Sockeye Salmon with paper label reading in part:  ***SKIPANON BRAND SEAFOOD SMOKED STEELHEAD***Ingredients:  Farm-Raised Steelhead, Sea Salt, Brown Sugar, Natural Hardwood Smoke.  NET WT. 5 1/2 oz. (156g)***''   UPC:  58071 00142  Code beginning with ''OC''    Label has a yellow background with a steel blue stripe at the bottom and multiple colored lettering.
Texas Style HEB Charro Beans NET WT. 15 OZ (425g) in metal cans UPC: 041220927142.  Texas Style HEB Charro Beans NET WT. 31 OZ (1.94 LB) 879g in metal cans UPC: 041220543692.
Texas Style HEB Charro Beans Spicy NET WT. 15 OZ (425g) in metal cans UPC: 041220927159.
Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 15 OZ (425g) in metal cans; Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 31 OZ (1.94 LB) 879g in metal cans.
US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.
distributed in Oregon and sold to internet customers nationwide.
ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC
Any codes starting with OC. Last date of distribution of recalled products was September 2015.
The canned Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum.
ALBACORE TUNA BELLIES, sold under brand The Garibaldi Cannery, Net weight 8 oz. (227 gram).  The word ''Bellies'' is  written on top of can. No UPC
The canned Albacore tuna bellies product is recalled because it has the potential to be contaminated with Clostridium botulinum.
ALBACORE TUNA NO SALT, sold under brand The Garibaldi Cannery, metal cans, net weight 8 oz. (227 gram).  No UPC
The canned Albacore tuna no salt product is recalled because it has the potential to be contaminated with Clostridium botulinum.
JALAPEO ALBACORE TUNA , sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram).  No UPC
The canned jalapeno Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum.
SMOKED ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram).  No UPC
The canned smoked Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum.
GARLIC ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram).  No UPC
The canned garlic Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum.
PACIFIC SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram).  No UPC
Any codes starting with OC.   Last date of distribution of recalled product was September 2015.
The canned Pacific Salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum.
SMOKED PACIFIC SALMON, sold under brand The Garibaldi Net weight 6 oz. (170 gram). No UPC
The canned smoked Pacific salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum.
SILVER SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC
The canned Silver salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum.
CHINOOK SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC
The canned Chinook salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum.
Blood products, collected using an improper arm scrub, were distributed.
The ''Pacifier Activated Lullaby'' (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply.  The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
NEW HAMPSHIRE, MASSACHUSETTS, NEW YORK, CONNECTICUT, PENNSYLVANIA, NEW JERSEY, MINNESOTA, WISCONSIN, SOUTH DAKOTA, INDIANA, NEBRASKA, MICHIGAN, MAINE, IOWA, DELAWARE, AND MARYLAND
Red Bull Total Zero Energy Drink, 12 fl.oz. (355ml), UPC CODE(S): ON THE CAN: 6 11269 62373 4; ON THE CASE: 6 11269 61505 0
Red Bull North America is recalling Red Bull Branded Total Zero Energy Drink because the cans are missing the statement ''Phenylketonurics: Contains Phenylalanine'', a mandatory requirement on all products that contain aspartame.
Medical Center/Hospitals in FL, MO, and TN.
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO  63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.
Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
Canned albacore tuna, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans.  No UPC.
Production codes starting with OC. The last date of distribution of recalled products is September 2015.
Canned albacore tuna, Dungeness Seaworks brand, with any code starting with ''OC'' was recalled because it has the potential to be contaminated with Clostridium botulinum.
Albacore Tuna Garlic, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans.  No UPC.
Canned Albacore Tuna Garlic, Dungeness Seaworks brand, with any code starting with ''OC'' was recalled because it has the potential to be contaminated with Clostridium botulinum.
Albacore Tuna Jalepeno, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans.  No UPC.
Canned Albacore Tuna Jalepeno, Dungeness Seaworks brand, with any code starting with ''OC'' was recalled because it has the potential to be contaminated with Clostridium botulinum.
Albacore Tuna Olive Oil, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans.  No UPC.
Canned Albacore Tuna Olive Oil, Dungeness Seaworks brand, with any code starting with ''OC'' was recalled because it has the potential to be contaminated with Clostridium botulinum.
Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans.  No UPC.
Canned Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, with any code starting with ''OC'' was recalled because it has the potential to be contaminated with Clostridium botulinum.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Plateletphersis products, with a low platelet yield, were distributed.
American National Red Cross, Greater Ozark-Arkansas Region
Blood product, possibly contaminated by air during collection, was distributed.
Worldwide Distribution.  US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain,  Switzerland,  Sweden, THAILAND,  United Kingdom, United Arab Emirates, and VIETNAM.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34.  Indicated for the removal of arterial emboli and thrombi.
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Lot Numbers: OTW3080 OTW3080  OTW3081  OTW3083  OTW3100
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48.  Indicated for the removal of arterial emboli and thrombi.
Lot Numbers: OTW3092OTW3084 OTW3084 (sample) OTW3087OTW3101
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88.  Indicated for the removal of arterial emboli and thrombi.
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78.  Indicated for the removal of arterial emboli and thrombi.
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84.  Indicated for the removal of arterial emboli and thrombi.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68.   Indicated for the removal of arterial emboli and thrombi.
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48.  Indicated for the removal of arterial emboli and thrombi.
Lot Number: SLC3636 SLC3636 (sample) SLC3636SLC3668 SLC3668SLC3669SLC3654 SLC3670
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58.  Indicated for the removal of arterial emboli and thrombi.
Lot Number: SLC3673SLC3637 SLC3637SLC3666 SLC3676SLC3689
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68.  Indicated for the removal of arterial emboli and thrombi.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26.  Indicated for the removal of arterial emboli and thrombi.
Misbranded Red Blood Cells were distributed.
Implant Direct Sybron Manufacturing, LLC
Worldwide Distribution- US (nationwide) including the states of  CA, FL, TX, MO, MI, MA, NV, OR, PA, AZ, IL, VA, OH, GA, and SC, and the country of Canada, Poland, Serbia, Italy, Germany, Cairo, Jordan, El Salvador, Kuwait, Costa Rica, Switzerland, Colombia, United Kingdom, Austria, Netherlands, Chile, and Egypt.
DGDE, DirectGuide Drill Extender.  Instrument for use with dental implants.   A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs.  The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
US Distribution to states of: CA, FL, MI  and WI.
Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures.  Intramedullary fixation rod, orthopedic.
Part Number Lot Number 04.037.162S 7950511
TFNA nails may have the locking mechanism too close to the top of the nail. This may 1.  Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood products, collected from a donor who may have received or had close contact with a smallpox vaccination, were distributed.
distributed in California, Illinois, Iowa, Maine, North Dakota, Oregon, and Pennsylvania.
IQF FLAV-R-PAC Cut Wax Beans, there are 12/2 lbs. bags per case.  Catalog # 07570.     Product was distributed to Food Service accounts.  The label has Cooking Directions and Safe Handling Instructions.      The UPC 0 48800 07570 5 is observed on the bag.  The Item No. 10048800075702 is observed on master case.    The product is labeled in part: ''***CUT WAX BEANS***FLAV-R-PAC***Keep Frozen***NET WT 32 OZ (2 LB)***DISTRIBUTED BY: NORPAC FOODS, INC. 4350 SW Galewood Street, Lake Oswego, OR 97035***COOKING DIRECTIONS***Safe Handling Instructions***''.
BEST BY MAY 2017. Packed on May 18, 2015.  Code: 5I5 18X8 12 HHMM    Code break down as follows:   5=NORPAC,  I= packed in May,   5= 2015,   18= 18th day of May,   X= place holder for period code,   8 = NORPAC Plant #8,   12= production line,   HHMM = military time of packaging.
IQF FLAV-R-PAC Cut Wax Beans, 12/2 lbs. distributed to food service accounts, are recalled due to the contamination with Listeria monocytogenes.
Product was shipped to the following states: AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, MI, MO, MS, MT, NC, NE, NM, NV, OH, SC, TN, UT, VA, WV & WY.
Kroger 100% natural apple FROM CONCENTRATE 64FL OZ. INGREDIENTS: APPLE JUICE FROM CONCENTRATE (FILTERED WATER, APPLE JUICE CONCENTRATE, ASCORBIC ACID (VITAMIN C). DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 82161 0
The firm received notification from the Alabama Dept. of Agriculture that a test came back indicating the levels of patulin was three times over the legal limit for patulin in two code dates of the Kroger Natural Apple Juice.
Blood products, collected from a donor who received body piercings within one year of donation, were distributed.
Wegmans Premium Dark Chocolate Pistachio Toffee, NET WT 9 OZ (255 g), UPC 0 77890 12698 1, Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603, Product contains tan and brown labels fixed to the top and bottom of the clear plastic tubs and shipped 12 units per case.
On November 11, 2015, First Source LLC initiated a recall for the Wegmans brand product due to the presence of undeclared cream (milk) in the toffee ingredient.
Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R),  Dental Implant
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Nationwide.  No foreign or military/govt/VA consignees.
WalkMed Infusion Triton Infusion Pump (model 300000). Packaged in a single pump box.  Four pump boxes are place in an over-shipper for distribution.
All devices manufactured since 07/04/09.
WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because of the potential for the device to deliver more than 25% over the target infusion rate.
WalkMed InfusionTriton fp Infusion Pump (model 400000). Packaged in a single pump box.  Four pump boxes are place in an over-shipper for distribution.
AMS 4674 Custom Pack.   For use in a general clinical procedure.
AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
AMS 4675 Angio Pack.    For use in a general clinical procedure.
AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
Plateletpheresis product, which monthly product QC test for pH was not performed, was distributed.
Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI; and countries of: AUSTRALIA, BELGIUM BRAZIL, CANADA, CHINA,DENMARK, FRANCE, GERMANY, HONG KONG, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, NORWAY, PERU, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
GE Healthcare, Revolution CT Scanners.     Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner.  A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.
Product was shipped to the following states: AK, CA, FL, GA, IL, IN, KS, MD, MI, MN, MS, NC, NH, OH, PA & TX.
ORGANIC HOMESTAT FARM Quick STEEL CUT OATS & CHIA with Flax and Rye Flakes NET WT 42 OZ (2 LB. 10 OZ.) INGREDIENTS:***organic milled flaxseed*** Distributed by Homestat Farm LTD 6065 Frantz Rd. Suite 206, Dublin, OH 43017 UPC 8 35882 00620 4
The firm was notified by their supplier that the Flax Meal delivered to them test positive for Salmonella Typhimurium.
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Apheresis blood products, possibly incorrectly labeled as having an extended expiration date, were distributed.
Blood products, collected from a donor considered to be at risk for variant Creutzfeldt- Jacob Disease (vCJD), were distributed.
KS, NE, OH, and WI.  No OUS distribution.
French Style Green Beans packaged under the following labels:  1.  Giant Eagle, Net Wt. 16 oz (1 LB) 454 g, UPC 30034-00978;  2. Shur fine, Net Wt. 16 oz, 1 LB (454 g), UPC 11161-13478
1.  Giant Eagle:  Packaging Code - TC15248;  Production Code - MTAB7135;  BEST BY 09/2017.    2.  Shur fine:  Packaging Code - TC65247; Production Code - MTAB7135;  BEST BY 09/2017
1374 cases total (12-16 oz. bags / case)
The 16 oz poly bags of IQF French Style Green Beans have the potential to be contaminated with Listeria monocytogenes.
AL, AZ, CA CO, IA, IL, IN, MD, MN, ND, PA, TX, VA & WA
1.) Essential EVERYDAY Chocolate Flavored Dairy Whipped Topping, Made with Real Cream, Ultra-Pasteurized Grade A, NET WT 13 OZ (368g); 2.) HyVee Chocolate FLAVORED WHIPPED TOPPING ULTRA-PASTEURIZED GRADE A - SWEETENED, NET WT 13 OZ (368g); 3.) Lucerne DAIRY FARMS Chocolate Whipped Topping MADE WITH REAL CREAM, NET WT 13 OZ (368g).
Lot Codes: 1.)  APR296JF23, Sell By Date APRIL296; 2.) APR296JF32, Sell By Date APRIL296; 3.) Lot Code DEC145G171, Sell By Date DEC145,  Lot Code DEC155G172, Sell By Date DEC155,  Lot Code FEB166G196, Sell By Date FEB166 &  Lot Code APR216G154, Sell By Date APRIL216
Saputo Dairy Foods USA, LLC initiated a recall due to the presence of undeclared Red # 40, Yellow # 5, Yellow # 6 and Blue # 1 food colorings.
International only Germany, Japan, Russia
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110   Bone fixation plate.
The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114   Bone fixation plate
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
Organic blenditup Protein + Plant Based Smoothie Mix, No Dairy, Vitamin Fortified, 100% Vegan, Mild Natural Flavor with a Hint of Sweetness, Net Wt. 24 oz (682g), packaged in plastic canister, 12 packages per case. Distributed by:  Blenditup, 504 W. Buena Vista, Suite 1, Washington, UT 84780
freeze by date of 08/22/2017 with a lot number of 151732; Item: 899352
Product adulterated. End user found a wingnut inside their canister; the firm determined that it came from the outside of the magnet unit attached to the blender. The wingnut looks bent out of shape and as a precautionary measure the firm wanted to recall all canisters produced during the affected lot.
Worldwide Distribution - USA (nationwide)  Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.
Thin-Flex Venous Cannula, Model Number:TF292902A
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03
Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02
Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16
Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01
Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01
Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
US Nationwide Distribution including these states: NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI.
Olympus ENDOEYE HD II Video Telescopes.  Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree.  The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.
MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only.  Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.
Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry: Feb-18; Lot #: GS009055, Expiry: Feb-18; Lot #: GS009131; Expiry: Feb-18.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only.  Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.