US: Nationwide including DC and  Puerto Rico.        OUS:  Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt,   France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel,   Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama,   Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain,   Thailand, United Arab Emirates, United Kingdom,  Vietnam.
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Reported incidents of a patient step detaching from the table.  A fall from a patient step detaching while in use could result in an injury to a patient or operator.
Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.
TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017
SHBG IMMULITE 2000/IMMULITE 2000 XPi  For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
Pausch Uroview FD fluoroscopic X-ray system  UDI number (01)04260491620040  Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. This footswitch is actively involved in the safety circuit of the urological table. Only if footswitch + exposure + first primary barrier are closed the signal will be transmitted to the generator for activating   X-ray. During intended use only with this footswitch X-ray should be activated.
model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
Worldwide distribution.  The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
There is a risk that the pinion gear in the device could fail under extreme use cases.
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis.  During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis.  NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
Lots 82 through 96 (listed on back of packaging) and Sell By Dates of  04/5-19/17
Refrigerated, ready-to-eat, sliced, hot  SMOKED TROUT fillets in 8 oz. vacuum packages -- KEEP REFRIGERATED-- 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
Refrigerated, ready-to-eat, sliced, cold smoked,  DOUBLE SMOKED IRISH SALMON, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages, UPC 0200000519438 -- KEEP REFRIGERATED,  STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY,  MAMARONECK, NY 10543
Refrigerated, ready-to-eat, sliced, cold smoked, GRAVLAX SALMON, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages, UPC  0200000608415 -- KEEP REFRIGERATED,  STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY,  MAMARONECK, NY 10543
Refrigerated, ready-to-eat, sliced, whole, split, hot SMOKED WHITEFISH in vacuum packages, labeled in part ,***  SMOKED WHITEFISH WHOLE *** -- KEEP REFRIGERATED 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY , MAMARONECK , NY 10543
Refrigerated, ready-to-eat, sliced, cold smoked, IMPORTED SCOTTISH SMOKED, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages, UPC 0200000620271 -- KEEP REFRIGERATED,  STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY,  MAMARONECK, NY 10543
Refrigerated, ready-to-eat, sliced, cold smoked, PASTRAMI SMOKED SALMON, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages -- KEEP REFRIGERATED,  STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY,  MAMARONECK, NY 10543
Refrigerated, ready-to-eat, sliced, hot SMOKED SABLE, BLACK COD, in 8 oz. vacuum packages, UPC 0200000810801 -- KEEP REFRIGERATED - 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY , MAMARONECK , NY 10543
Refrigerated, ready-to-eat, sliced, cold smoked, SMOKED NORWEGIAN SALMON in 4 oz., 8 oz., & whole sides in vacuum packages -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY,  MAMARONECK, NY 10543
Lots 82 through 96 (listed on back of packaging) and Sell By Dates of 04/5-19/17
Refrigerated, ready-to-eat, hot SMOKED STURGEON, HAND SLICED PACKS, 4 OZ. in vacuum packages, UPC 0200000309800 -- KEEP REFRIGERATED -- STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY , MAMARONECK, NY 10543
Refrigerated, ready-to-eat BAKED KIPPERED SALMON, in 8 oz. vacuum packages, UPC 0200000615659 -- KEEP REFRIGERATED 38 DEGREES or Below --- THE SMOKEHOUSE OF NY , MAMARONECK , NY 10543
Refrigerated, ready-to-eat, sliced, cold smoked salmon, CHOPPED TRIMMINGS in 8 oz. vacuum packages, UPC 0200000406622 -- KEEP REFRIGERATED,  STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY,  MAMARONECK, NY 10543
Worldwide distribution - US Nationwide in the states: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, NEW JERSEY, New York, NORTH CAROLINA, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.  Product was also distributed to the following foreign countries: Canada, Hong Kong, Kuwait, Pakistan,
Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
One complaint of a seat on a scale failing unexpectedly which can cause an injury.
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set   Model Number(s): L7572.    For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
US Distribution including PR and to the states of :  LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX.
Dolphin Inflation Device, REF 0185NA.  Rx only, Sterilized using Ethylene Oxide.      DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters.  The device itself consists of two components - the inflation device and large volume syringe (30 cc).    The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device.  Careful and controlled inflation is achieved by rotating the handle clockwise.  During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device.    Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device.    All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier.  Use of affected product could pose a risk of microbial contamination, leading to infection.
e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays
Lot Number:  189285  Expiration Date:  10/31/2017  Part Number:  PreciControl Varia: 05618860160
US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico.
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training.  The device is to be implanted by the surgeon in a sterile operating room setting.  Implants are provided in sterile packages.    The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices.    Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts)
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market.  The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.   Below are Part numbers/ Description per set:    5001-0106N-S ARH Slide-Loc Standard Stem 6mm  5001-0107N-S ARH Slide-Loc Standard Stem 7mm  5001-0108N-S ARH Slide-Loc Standard Stem 8mm  5001-0109N-S ARH Slide-Loc Standard Stem 9mm  5001-0110N-S ARH Slide-Loc Standard Stem 10mm  5001-0111N-S ARH Slide-Loc Standard Stem 11mm  5001-0112N-S ARH Slide-Loc Standard Stem 12mm  5001-0218L-S ARH Slide-Loc Head 18mm, Left  5001-0218R-S ARH Slide-Loc Head 18mm, Right  5001-0220L-S ARH Slide-Loc Head 20mm, Left  5001-0220R-S ARH Slide-Loc Head 20mm, Right  5001-0222L-S ARH Slide-Loc Head 22mm, Left  5001-0222R-S ARH Slide-Loc Head 22mm, Right  5001-0224L-S ARH Slide-Loc Head 24mm, Left  5001-0224R-S ARH Slide-Loc Head 24mm, Right  5001-0226L-S ARH Slide-Loc Head 26mm, Left  5001-0226R-S ARH Slide-Loc Head 26mm, Right  5001-0228L-S ARH Slide-Loc Head 28mm, Left  5001-0228R-S ARH Slide-Loc Head 28mm, Right  5001-0301N-S ARH Slide-Loc Neck +1mm  5001-0303N-S ARH Slide-Loc Neck +3mm  5001-0305N-S ARH Slide-Loc Neck +5mm  5001-0406L-S ARH Slide-Loc Long Stem 6mm, Left  5001-0406R-S ARH Slide-Loc Long Stem 6mm, Right  5001-0408L-S ARH Slide-Loc Long Stem 8mm, Left  5001-0408R-S ARH Slide-Loc Long Stem 8mm, Right  5001-0410L-S ARH Slide-Loc Long Stem 10mm, Left  5001-0410R-S ARH Slide-Loc Long Stem 10mm, Right  5001-0412L-S ARH Slide-Loc Long Stem 12mm, Left  5001-0412R-S ARH Slide-Loc Long Stem 12mm, Right  5101-0106N ARH Slide-Loc Trial Standard Stem 6mm  5101-0107N ARH Slide-Loc Trial Standard Stem 7mm  5101-0108N ARH Slide-Loc Trial Standard Stem 8mm  5101-0109N ARH Slide-Loc Trial Standard Stem 9mm  5101-0110N ARH Slide-Loc Trial Standard Stem 10mm  5101-0111N ARH Slide-Loc Trial Standard Stem 11mm  5101-0218L ARH Slide-Loc Trial Head 18mm, Left  5101-0218R ARH Slide-Loc Trial Head 18mm, Right  5101-0220L ARH Slide-Loc Trial Head 20mm, Left  5101-0220R ARH Slide-Loc Trial Head 20mm, Right  5101-0222L ARH Slide-Loc Trial Head 22mm, Left
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ   NDC 0781-1831-20
Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY  Foreign: Canada
Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot.  This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty
Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.
Model Number: 113956, Modular Hybrid Glenoid Base Large, Item Number: 113956,  Lot Number: 270260,  UDI Number: (01) 00880304462618 (17) 211204 (10) 270260
Blood and Blood Products for Reprocessing
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Product was shipped to all US states plus the District of Columbia.    Product was also shipped to Canada and Australia.
A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly.
MN: 6632;  Date Code begging with FT150701 through  FT170228
Nationwide, Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Norway, Portugal, Romania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey
AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia).  The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.
Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, which did not meet acceptable product specifications, was distributed.
Lifesouth Community Blood Centers - Montgomery Region
Apheresis Platelets, Leukocytes Reduced, Irradiated
Worldwide Distribution - US Distribution to Puerto Rico and to the countries of :  Canada  Kuwait  Chile  Poland  China  Romania  France  Saudi Arabia  Guatemala  Slovenia  Iran  UAE  India  UK  Italy  Uruguay  Iraq
Liquid Urine Control Level 3    For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product.    As control results will be outside of the quoted range this may result in a delay in reporting the sample test results.     However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice
Catalogue number  UC5075  Batch number  907UC
Blood products, in which donor screening/deferral screening not done or incorrectly performed, were distributed.
Blood product, in which donor gave history which warranted deferral or follow up was not deferred or follow up questions was not asked, was distributed.
Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5).    The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent  Catalogue Number: HY0305Z
Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
Philips Electronics North  America Corporation
US: AK  AZ  CA  CO  FL  HI  IA  IL  IN  KY  MA  MD  MI  MN  MO  MS  NC  NE  NH  NJ  NM  NV  NY  OH  OR  PA  TX  VA  WA  WI  WV    OUS: Algeria  Argentina  Australia  Austria  Bahrain  Belarus  Belgium  Bolivia  Brazil  Canada  Chile  China  Colombia  Costa Rica  Denmark  Dominican Rep  Egypt  Finland  France  Germany  Hong Kong  Hungary  Iceland  India  Indonesia  Ireland  Israel  Italy  Japan  Latvia  Lebanon  Libya  Lithuania  Luxembourg  Malaysia  Mexico  Mongolia  Netherlands  New Zealand  Norway  Oman  Pakistan  Peru  Philippines  Poland  Portugal  Qatar  Romania  Russia  Russian Fed.  Saudi Arabia  Singapore  Slovenia  South Africa  South Korea  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Ukraine  United Kingdom  Utd.Arab.Emir.
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Manufacturing defect may cause localized heating, which may result in localized skin burn.
just Cookie Dough Peanut Butter Chocolate Chip, Net Wt 14 oz (397g).  Keep Refrigerated.
Cookie Dough was manufactured with flour recalled by the supplier, due to Salmonella contamination.
just Cookie Dough Chocolate Chip, Net Wt 14 oz (397g).  Keep Refrigerated.
US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA,  WA,  AR,  NJ, MD, OK, IN and NH.
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
Robin Hood ENRICHED & PRE-SIFTED ALL PURPOSE flour ORIGINAL, UPC 0 59000 01632 0, 1 kg
Lot codes containing BB/MA 6 288 548, 6 289 548, 6 290 548, 6 291 548  Best Before April 2018
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Estrogen Receptor (EP1)   7.0 mL Catalog number  249R-28;  1.0 mL Catalog number  249R-16    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
as required by section 801 (e )(1) of the FD&C Act.
Herpes Simplex Virus I;  7.0 mL Catalog number 361A-18.    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
Estrogen Receptor (SP1)   7.0 mL Catalog number 249R-18;    Hematology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
Her2/Neu (c-erbB-2) (CB-1 1);  7.0 mL Catalog number 237M-18.  In vitro diagnostic use - Analyte Specific Reagent    Immunology - Analyte Specific Reagent
Adenovirus (20/11 & 2/6);   0.5 mL  Catalog # 212M-15;  and 7.0 mL Catalog number 212M-18    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
Herpes Simplex Virus II  0.5 ml catalog number 362A-15  7.0 mL Catalog number362A-18 .    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
Varicella Zoster Virus  7.0 ml catalog number 364M-18    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
SV40 (MRQ-4)  0.5 ml catalog number  351 M-15.    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
H. pylori (polyclonal}  1.0 mL Catalog number 215A-76;    Hematology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
CD117, c-kit (YR145)  1.0 ml catalog number 117R-16  7.0 ml catalog number-18    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
HHV-8 (13810);  1.0 ml catalog number 265M-16;  7.0 ml catalog number-265M-18;    Microbiology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
Her2/Neu (EP3);  0.5 mL Catalog number 237R-25;  1.0 mL Catalog number 237R-26;  7.0 mL Catalog number 237R-28.    Immunology - Analyte Specific Reagent  In vitro diagnostic use - Analyte Specific Reagent
Blood products, which did not meet acceptable product specifications, were distributed
Worldwide - US Nationwide and the countries of AUSTRALIA,  CANADA,  CHILE, COLOMBIA, COSTA RICA,  NETHERLANDS,  JAPAN, SPAIN AND CANARY ISLANDS, SWITZERLAND and UNITED KINGDOM.
AFFIXUS Hip Fracture Nail    Product Usage:  The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
nail not properly engaging with the targeting jig due to certain undersized specification
LOT  DLBH21  DLFB60  DLFB61  DLFB62  DLFB63  DLFB64  DLFB65  DLFB66  DLFB67  DLFB68  DLFB69  DLFB6Z  DLFB77  DLFB7B  DLFB7C  DLFB7D  DLFB7F  DLFB7G  DLFB7H  DLFB7J  DLFB7K  DLFB7L  DLFB7L  DLFB7M  DLFB7N  DLFB7P  DLFB7R  DLFB7T  DLFB7V  DLFB7W  DLFB7Y  DLFB7Z  DLFBB0  DLFBB1  DLFBB2  DLFBB3  DLFBB4  DLFBB5  DLFBB6  DLFBB7  DLFBB8  DLFBB9  DLFBBW  DLFBBY  DLFBBZ  DLFBCB  DLFBCC  DLFBCD  DLFBDG  DLFBDH  DLFBDJ  DLFBDJ  DLFBDK  DLFBDL  DLFBDM  DLFBDN  DLFBDP  DLFBDR  DLFBDT  DLFBDV  DLG  DLGB70  DLGB71  DLGB72  DLGB73  DLGB74  DLGB75  DLGB76  DLGB77  DLGB78  DLGB79  DLGB7C  DLGB7D  DLGB7P  DLGB7R  DLGB7T  DLGB7V  DLGB7W  DLGB7Y  DLGB7Z  DLGB8  DLGB80  DLGB81  DLGB82  DLGB83  DLGB84  DLGB85  DLGB86  DLGB87  DLGB88  DLGB89  DLGB8B  DLGB8C  DLGB8D  DLGB8F  DLGB8G  DLGB8H  DLGB8J  DLGB8K  DLGB8L  DLGB8M  DLGB8N  DLGB8P  DLGB8R  DLGB8R  DLGB8T  DLGB8V  DLGB8W  DLGB8Y  DLGB8Z  DLGB9B  DLGB9C  DLGB9D  DLGB9F  DLGB9G  DLGB9H  DLGB9J  DLGB9K  DLGB9L  DLGB9M  DLGB9N  DLGBC  DLGBC0  DLGBC1  DLGBC3  DLGBC4  DLGBC8  DLGBC9  DLGBCL  DLGBCM  DLGBCN  DLGBCP  DLGBCR  DLGBCT  DLGBCV  DLGBCW  DLGBCY  DLGBCZ  DLGBDF  DLGBDG  DLGBDJ  DLGBDK  DLGBJ0  DLGBJ1  DLGBJ2  DLGBJ3  DLGBJ4  DLGBJ5  DLGBJ6  DLGBJ7  DLGBJ8  DLGBJ9  DLGBJV  DLGBJW  DLGBJY  DLGBKB  DLGBKC  DLGBKC  DLGBKD  DLGBKF  DLGBKG  DLGBKJ  DLGBKK  DLGBKL  DLGBKM  DLGBKN  DLGBKP  DLGBKR  DLGBKT  DLGBN4  DLGBN5  DLGBN6  DLGBN7  DLGBNV  DLGBPD  DLGBPF  DLGBPG  DLGBPH  DLGBPJ  DLGBPK  DLGBPL  DLGBPM  DLGBPN  DLGBPP  DLGBPT  DLGBT2  DLGBT3  DLGBT5  DLGBT6  DLGBT8  DLGBT9  DLGBV0  DLGBV1  DLGBV2  DLGBV3  DLGBV4  DLGBV5  DLGBV6  DLGBV7  DLGBV8  DLGBV9  DLGBVB  DLGBVC  DLGBVD  DLGBVF  DLGBVG  DLGBVH  DLGBVJ  DLGBVK  DLGBVL  DLGBVM  DLGBVN  DLGBVP  DLGBVR  DLGBVT  DLGBVV  DLGBVW  DLGBVY  DLGBVZ  DLGBWB  DLGBWC  DLGBWD  DLGBWF  DLGBWG  DLHB2  DLHB21  DLHB22  DLHB23  DLHB24  DLHB25  DLHB26  DLHB27  DLHB28  DLHB29  DLHB30  DLHB31  DLHB32  DLHB33  DLHB34  DLHB35  DLHB36  DLHB37  DLHB38  DLHB39  DLHB3B  DLHB3C  DLHB3D  DLHB3F  DLHB3G  DLHB3H  DLHB3J  DLHB3K  DLHB3L  DLHB3M  DLHB3N  DLHB3P
Queso Hondureno, Queso Duro Blando - Honduran Cheese, Dry Hard Cheese; 1 lb 454 g
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Durability characteristics of reusable instruments were not established
All lots in distribution prior to 5/8/17
Tuna King Tuna Steaks 10oz.. ,10lb Box. Frozen  UPC Codes: 8158380206764
Mikawaya Mochi Ice Cream Chocolate Chocolate, 6-1.5oz (43g) pieces, Net Wt. 9.1oz (258g), UPC 070934990609, 24 boxes/case
Mikawaya is recalling Mochi Ice Cream Chocolate Chocolate because it may contain Chocolate Peanut Butter Ice Cream.
Trident Seafoods Corp - Island Enterprise M/V
distributed in AK, AL, AZ, CA, CO, IA, ID, IL, KS, LA, MA, MI, MN, MO, MS, NE, NJ, OH, OR, PA, SC, TN, TX, VT, WA, and WI.
Trident Item # 16582, Alaska Cod Rectangles 4 oz, Raw Breaded, food service packages, frozen, Net wt. 10 lbs.
Alaska Cod Rectangles 4 oz product is recalled because they may contain small pieces of plastic.
Trident Item # 474568, Irregulars Battered Cod 3 oz Battered Diamonds, food service packages, frozen, Net wt. 10 lbs.
Irregulars Battered Cod 3 oz Battered Diamonds is recalled because it may contain small pieces of plastic.
Trident Item # 17116, Alaska Cod Rectangles 3 oz,Crunchy Breaded, food service packages, frozen, Net wt. 10 lbs.
Alaska Cod Rectangles 3 oz is recalled because it may contain small pieces of plastic.
Trident Item # 474568, Irregulars Breaded Cod 2 oz. 10 Grain Cod, food service packages, frozen, Net wt. 10 lbs.
Irregulars Breaded Cod 2 oz. 10 Grain Cod product is recalled because it may contain small pieces of plastic.
Multi-Grain Alaskan Cod, Frozen product,  retail 12 oz. packages are recalled because they may contain small pieces of plastic.
Trident Item # 16595, Alaska Cod Squares 4 oz, raw breaded panko, food service packages, frozen, Net wt. 10 lbs.
Alaska Cod Squares 4 oz product is recalled because they may contain small pieces of plastic.
Lot A633534. No best by dates marked.  Lot K706271. No best by dates marked.
Trident Item # 38520, Panko Breaded Alaska Cod, 4 oz. Square Portions Raw, Food Service packages, frozen, Net Wt. 10 lbs.
Panko Breaded Alaska Cod 4 oz. product is recalled because it may contain small pieces of plastic.
Trident Item # 16596, Alaska Cod Diamond Cut 3 oz, English Style Battered Deep Fry, food service packages, frozen, Net wt. 10 lbs.
Alaska Cod Diamond Cut Squares 3 oz product is recalled because they may contain small pieces of plastic.
Exact Sciences Sample Mixer 2.  For In Vitro Diagnostic Use.  The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests
Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.
US only to distributors in MD, MA, CA, FL, IN, WA and TX
Kite Hill Mushroom and Ricotta Ravioli; frozen Ravioli made with almond milk ricotta:  9 oz. package. UPC 856624004173        Owned and distributed by Lyrical Foods, Hayward, CA.
Ingredient statement for Lyrical Foods Mushroom and Ricotta Flavor Ravioli does not include the ingredient of garlic.
Worldwide - US Nationwide in the state IL and the country of COLOMBIA
Beef Extract Powder, Acumedia PN 7228    Product Usage:  Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
Incorrect expiration date on label.  Correct expiration date was March 25, 2019. Product was labeled with expiration date  of March 28,2019.
Domestic only: FL,GA, IA, IL, KY, TX, MI, MN, NJ,  OH,  PA,   SC, TX, VA, WI
Chef Pierre 10 Spinach Quiche, and 6/10 Frozen Quiche, 38 oz. packed in a paper carton, keep frozen
The firm is voluntarily recalling multiple lots of frozen Chef Pierre 10 Spinach Quiche,  Chef Pierre 6/10 Frozen Quiche, and Sara Lee CP Quiche 10 Spinach following an ingredient supplier's recall due to Listeria monocytogenes.
Sara Lee CP Quiche 10 Spinach , 38 oz. packed in a paper carton, keep frozen
Sara Lee CP Quiche 10 Spinach, Case label SKU: 05799, Code Dates: 1701246610 &1701246620
Worldwide - US Nationwide in the state of ME; in the country of  ECUADOR
Nutrient Gelatin, Acumedia Part Number 7471 A    Product Usage:  Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.
Sabouraud Dextrose Agar w /Lecithin and Tween 20  Acumedia PN 91081    Product Usage:  Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Artic Cascade and DOT Foods.  No VA/govt/military or foreign consignees.
Bean & Cheddar with Salsa, FIRE ROASTED Corn & Red Bell Pepper Burrito.  MILD, Net WT 7oz, Item # 886, Case UPC 833425001464, Item UPC 8 33425 00336 9. Packaged in Paper Wrap sealed with Item Label, 12 units per case.  Frozen or refrigerated.
Green Chile Concepts, LLC is voluntarily recalling certain Green Chile Food Company brand burritos sold frozen, refrigerated and/or served hot in certain convenience stores, vending machines, and retail locations because they may have the potential to be contaminated with Listeria monocytogenes.
Case Lot Code:  March 30, 2017; Production Date:  3/30/2017
Bean & Cheese Burrito with Monterey Jack, Salsa, Green Chile, Rice, & Serrano Peppers!, Item # 484, Case UPC 8 33425 00086 3, Item UPC 8 83350 02411 3. Unit Size 8oz. Packaged in Paper Wrap sealed with Item Label, 12 units per case.  Frozen or refrigerated.
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR  72205, NDC 70004-0100-32.
Lack of assurance of sterility: Product bags leaking at seam.
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205,  NDC: 70004-0737-32
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g,  Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205,   NDC 70004-0522-32
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g,  Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205,  NDC 70004-0524-32
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL,  Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR  72205, NDC 70004-0100-55
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Distributed to CO,WY,SC,WA.  No foreign or govt/VA/military consignees.
The Green Herb 100% Natural AL-ER-G, 60 and 150 Capsules, Dietary supplement, This item is packed in a white bottle with a white cap.  Each bottle contains 60 or 150 capsules, each capsule is 180 mg of ephedra herb in a 650 mg capsule. Batch#1892; product# 314.
MusclMasster, LLC is recalling all bottles of Al-Er-G Capsules because they contain the presence of Ephedra Herb, an FDA banned ingredient.