Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China,  El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile
A raw material anomaly was discovered during inspection at Zimmer Biomet, and an investigation by the supplier determined that 4 lots of raw material could have similar anomalies.  The anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture.  Accordingly, all products manufactured with the affected raw material are being removed from the field.
ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile
ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile
Drill Bit Quick-Connect  3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile
Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile
Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile
Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile
Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile
ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile
Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile
Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile
NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile
Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile
ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile
Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter,  Item Number/EDI 00236020527, Nonsterile
Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile
Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile
ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile
Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile
Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile
ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile
ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile
Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile
ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile
ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile
Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile
M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile
M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile
NCB Periprosthetic Plate System Drill Bit With Quick-Couping 3.5 mm Diameter 195 mm  Length, Item Number/EDI 0200024325, Nonsterile
ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile
ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile
ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile
ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile
Drill Bit Quick-Connect 1.1 mm Diameter 60 mm  Length, Item Number/EDI 00480606011, Nonsterile
M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile
ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm  Length, Item Number/EDI 00480507015, Nonsterile
Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile
ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile
Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile
M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile
ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile
ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile
Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile
Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile
Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile
ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile
ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile
Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile
Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile
Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile
ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile
ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile
M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile
Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile
Wegmans Dark Chocolate Cherry Cashew chewy granola bars, 12-1.4OZ(40g) bars, Total Net Wt. 16.8OZ (1 LB 0.8OZ) 480g, UPC 77890-42230
Wegmans Dark Chocolate Cherry Cashew Bars are recalled because there may be a higher concentration of Vitamin A, than what is declared
Product was shipped to the following states: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA & WI.    Product was also shipped to Canada.
Marketside CLASSIC HUMMUS WITH PINE NUTS NET WT. 10 oz (283g)
The firm was notified by their ingredient supplier that the pine nuts may be contaminated with Listeria monocytogenes.
Expiration & Lot Codes: USE BY 28 JUN 2017A W1704194, USE BY 19 JUN 2017A W1704066 & USE BY 19 JUN 2017A W1704065.
FRESH FOODS MARKET Artisan Humus Pine Nuts NET WT 10 oz (283g)
LANTANA White Bean HUMMUS NET WT. 10 oz (283g)
Distribution was nationwide.  Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany.  There was no military /government distribution.
Ultradent Products, Inc.  Paper Points, Size 45 PN #1558, 200 per container, sterile.     Product Usage:  The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F
Ultradent Products, Inc.  Paper Points, Size 25 PN #1554, 200 per container, sterile.      Product Usage:  The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Ultradent Products, Inc.  Paper Points, Size 30 PN #1555, 200 per container, sterile.      Product Usage:  The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Ultradent Products, Inc.  Paper Points, Size 20 PN #1560, 200 per container, sterile.     Product Usage:  The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Ultradent Products, Inc.  Paper Points, Size 50 PN #1559, 200 per container, sterile.      Product Usage:  The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
Lot numbers BCKKP, BD2D4, BD8BY, BDH3Q, and BDTBL
Worldwide Distribution. US (nationwide) to states of:  CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
(18 cm x 265 cm),  Ref. HH2000 (single drape), Sterile, Rx.   Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.    The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream  Health, Inc., Rochester, NY.    The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.
(18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.    The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A;    MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S;    IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A;    IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S;    IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A;    IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S;    MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A;    IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
ABUT GOLD FRICTION-FIT, REF HLA3G;   ABUT GOLD FRICTION-FIT, REF HLA4G;  COPING GOLD ENG 5.7 MM, REF HLA5G;  COPING GOLD NON-ENG. 3.5, REF NEA3G;  COPING GOLD NON-ENG. 4.5, REF NEA4G
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A;  WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S;  WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A;  WAXING COPING, CONT 4.5MM, REF ZOCWAX4S;  WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A;  WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S;   WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A;  WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10;    IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11;    IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13;    IMPLANT 1-PC STR 3.0X10, REF ZOP30S10;    IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11;  IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34;    TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45;    TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56;    TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom.
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only.    Product Usage:  It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Model Number 590-001, Lots FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A
INTERNATIONAL ONLY:  GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ      The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.
Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
Blood products, in which component preparation were not prepared in accordance with specifications, were distributed.
Percuvance Clip Applier Tool Tip   The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
For some of the recalled products, the security of the connection between the shaft and the tool tip  may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
Percuvance Gripper Grasper Tool Tip   The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
Percuvance Scissors Tool Tip   The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
Percuvance 29cm Shaft   The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
Percuvance Johans Grasper Tool Tip   The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
Percuvance Maryland Dissector Tool Tip   The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c)   MAD720 MADgic   Intended for the application of topical anesthetics to the oropharynx and upper airway region
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator,   Biventricular or ventricular antitachycardia pacing,   Dual or single chamber arrhythmia detection    Product  Usage:  PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator,   Biventricular or ventricular antitachycardia pacing,   Dual or single chamber arrhythmia detection    Product  Usage:  PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator,   Biventricular or ventricular antitachycardia pacing,   Dual or single chamber arrhythmia detection    Product  Usage:  PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator,   Biventricular or ventricular antitachycardia pacing,   Dual or single chamber arrhythmia detection    Product  Usage:  PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
There is a possibility of overconsumption of certain  PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization  Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the  implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to  take.
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator,   Biventricular or ventricular antitachycardia pacing,   Dual or single chamber arrhythmia detection    Product  Usage:  PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator,   Biventricular or ventricular antitachycardia pacing,   Dual or single chamber arrhythmia detection    Product  Usage:  PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Domestic Only: MI, FL, SC, OH, KY, WI, MO, PA, and IL
Sunflower Seeds Honey Roasted, 12oz Tubs & 25lb Bulk
702 cases of Lot 895611, and 347 cases of Lot 709542
Lipari Foods LLC initiated a voluntary recall of Honey Roasted Sunflower Seeds, 12oz Tubs & 25lb Bulk, due to an off taste following a consumer complaint and mislabeled shelf life.
895611 -12-12oz Tub Lg Sunflower Kernal Honey Roasted, UPC: 673316036539;  709542-1/25# Sunflower Seeds Honey Roasted, UPC: 094776000630 Production Lot Codes: 70331R, 70191R & 71541R
Rajbhog Sweet, JALEBI, Net Weight 11.2 oz. (315 grams), Distributed by Rajbhog Distributors (GA) Inc., Duluth, GA 30096.
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054; NDC 16252-523-01.
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
FUJINON ED-530XT.    This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device.    The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
Alabama, Florida, Georgia, Louisiana, and Mississippi
Vegetable Kabob, 23-oz. packaged in an overwrap; Kabob Sensations Veggie Kabob, 15-oz. packaged in am overwrap; Marketside Veggie Kabobs, 23-oz. packaged in an overwrap
Potential contamination with Listeria monocytogenes.
Use by date range 8/12-18/2017 and Use by date range 8/12-18/2017 and Use by date range 8/13-20/2017
Creole Mix, 6-oz. packaged in a clamshell
Fajita Blend, 12-oz. packaged in an overwrap
Stir Fry Vegetable, 10-oz. packaged in an overwrap
Tri-Pepper Dice, 6-oz. packaged in a clamshell and Dice Tri-Pepper, 7-oz. packaged in a clamshell
Use by date range 8/12-19/2017 and Use by date range 8/13-20/2017
Green Pepper Diced, 6-oz. packaged in a clamshell
Fajita Mix,  6-oz. packaged in a clamshell
The product was shipped to the following state: CA & CO
Homestyle Broccoli and Cheese Soup, 1.66 lb Plastic boil-n-bag pouches, frozen,  Contains: Milk, Soy, Wheat
The firm was notified by a customer that they found pieces of plastic in the product.
Source Plasma, collected from a donor with unreported tattoos, was distributed.
US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only     The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.
It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.
Shawnee Mills Peppered Gravy Mix, 2.75 oz and 24 oz.
Potential for foreign material in a food product.
Product was distributed to one consignee in Louisiana.
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA  91730.
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ  08540.
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.