Nationwide Distribution --  AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901.   Designed to automate sample handling and processing in the clinical laboratory.
Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.
Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden.   .
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx  Only***   This device is intended to be used with Anspach Systems
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.
ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only***   This device is intended to be used with Anspach Systems
Part Number 98-0020, Serial Number: 200423
The Anspach Effort, Inc.  in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only***   This device is intended to be used with Anspach Systems
Part Number 98-0022. Serial Number: 2000040
ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only***   This device is intended to be used with Anspach Systems
Part Number 98-0029; Serial Number: 20000263
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0001***eMax Hand Control***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***MA Attachment, Straight version Custom***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment  (Non-Sterile)***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0010; Serial Number: 200341
ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0019; Serial Number: 200422
ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0023; Serial Number: 2000288
ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0024; Serial Number: 2000100
ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0025; Serial Number: 2000220
ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0037; Serial Number: 2000940.
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0044; Serial Number: E16200088601.
ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0048; Serial Number: 200073101.
ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0056; Serial Number: 30978704
ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0062; Serial Number: E15200088401.
ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: SP-3012-00; Serial Number: 200294
ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF SP-3014-00***4mm Fluted Ball  for MRI***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: SP-3101-00; Serial Number: 200045
ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: SP-4601-00; Serial Number: 200093
ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: SP-4602-00; Serial Numbers: 200278, 200094
ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only***   This device is intended to be used with Anspach Systems
ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: SP-5001-00; Serial Number: 200252
ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0012; Serial Number: 201421
ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only***   This device is intended to be used with Anspach Systems
Part Number: 98-0033; Serial Number: 200055701
Nationwide Distribution including Puerto Rico
Siemens Dimension LOCI TNI Troponin I Calibrator The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.  RC621.
Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
Part Number        Lot number OIM-101               OIM15091  OIM-202               OIM15092  OIM-303               OIM15093  OIM-SP          OIM1509S.  All lots have an expiration date of 9/30/2015.
The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
Part Number        Lot number   OPR0-101            OPR015101  OPR0-202            OPR015102  OPR0-303            OPR015103  OPRO-SP             OPR01510S      All lots have an expiration date of 10/31/2015.
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc.,  NDC 0008-1211-30
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
CA, FL, GA, IL, MD, NC, OH, PA, VA, and WA
Floribbean Key Lime Calypso Dip 12.5 oz Floribbean 68 SW 40 St. Suite 411 Miami, Florida 33155  1(800)282-8459
During an FDA inspection a product was found that the label fail to declared the component ingredients of all its compound ingredients like Mayonnaise and Worcestershire sauce that contains allergens like eggs, soy, and anchovies.
Marissa Collection Tangerine Appetizer Plate Set (set of 2). distributed by Princess House Inc., Taunton, MA
Plates leaching cadmium above the specified acceptable level
Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
American National Red Cross, Penn Jersey Region
Blood products, collected from a donor with a history of an unspecified type of hepatitis, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Oklahoma Blood Institute - Sylvan N Goldman Center
Blood products, collected in a manner that may have  compromised the sterility of the units, were distributed.
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
Blood components, incorrectly labeled as units of Fresh Frozen Plasma, were distributed.
Blood products, collected from a donor whose physical examination was incomplete, were distributed.
American Red Cross Blood Svs. Indiana-Ohio Region
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Blood products, labeled with extended expiration dates following irradiation, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
American Red Cross Greater Alleghenies Region
Blood product, with platelet concentration below the specified minimum requirement, was distributed.
American Natl Red Cross Mid Atlantic Region
Blood product, incorrectly identified as negative for the Jka antigen, was distributed.
North Carolina; Missouri; New York; New Jersey; Switzerland; California
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
American National Red Cross, Northeastern Region
American National Red Cross (The) - North Central Region
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Distribution to US (states: MA, NY, OH, PA & TX) and Canada.
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation.  Model numbers YG19051 and YG19262.
Potential for the welded seam in affected monitor spring arms to crack and/or break.
*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT,  WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Barbados, Canada, Costa Rica,  Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U- R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01;  single use; Hospira
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-  01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No.  06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set.  Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira
LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-  01; Hospira
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01;  Single Use; Hospira
Blood product, labeled with an extended expiration date following irradiation, was distributed.
American National Red Cross Southeastern Michigan Region
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
American National Red Cross Great Lakes Region
Blood products, labeled with extended expiration dates, were distributed.
Minnesota; Pennsylvania; Arkansas; District of Columbia; Puerto Rico; New Jersey; Wisconsin; Maryland
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections.  In this case the difference between the red and green projection was up to 2.5mm.
Blood products, positive for the M-antigen but labeled  negative for the M-antigen, were distributed.
Blood product, collected from a donor with an unacceptable temperature, was distributed.
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number:      02-6000-050 , Lot Number: 132160.   Product Usage:  Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
This lot (132160) of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix.  Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.
Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.
Nationwide, Puerto Rico, Canada, and Hong Kong.
Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL  33637.
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL  REF: SAK-301  Lactate 45, Potassium  1, Sodium 140, Calcium 3, Magnesium 1,  Chloride 100, Glucose (mg/dL) 100  Batch Size (liters) 60    The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL  REF: SAK-302  Lactate , 40, Potassium 1, Sodium 140, Calcium 3,  Magnesium 1, Chloride 105, Glucose (mg/dL) 100,   Batch Size (liters): 60     The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL  REF: SAK-303  Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m   Chloride 100m, Glucose (mg/dL) 100  Batch Size (liters) 50      The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL  REF: SAK-305  Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1  Chloride 100, Glucose (mg/dL) 100  Batch Size (liters) 40
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL  REF: SAK-306  Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1,   Chloride 101, Glucose (mg/dL) 100  Batch Size (liters) 50    The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL  REF: SAK-307  Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,   Chloride 105, Glucose (mg/dL) 100  Batch Size (liters) 50    The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL  REF: SAK-407  Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,   Chloride 105, Glucose (mg/dL) 100  Batch Size (liters) 50
Blood products, incorrectly labeled as negative for the Jka red cell antigen, were distributed.
Blood product, which was incorrectly labeled as negative for the S red cell antigen, was distributed.
GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces, 15% New Wt. 25 lbs.    GSF  LLC, Visalia, CA 93290
FDA sample found positive for Listeria monocytogenes.
California Grown Shelled Walnuts, Net Weight 12 oz (340g), UPC 69887507806   46 cases, 24 count, 12 oz packages.
Sun Tree is recalling California Grown Shelled Walnuts because they may be contaminated with Listeria monocytogenes.
Worldwide Distribution -  USA (nationwide) including Puerto Rico and the states of  AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, VT, VA and WA,. and the countries of Australia, Canada, New Zealand and United Kingdom.
MOSAIQ   MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.
Nationwide Distribution and the country of Colombia.
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement ''Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions'' was not printed on the product label.
Shaver Handpiece Sterilization Tray. Model number 272-700-000.  For sterilization of Stryker Endoscopy arthroscopic shaver.
STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
Nationwide distribution and to Bahrain Costa Rica, Estonia, Goias, Iceland, Israel, New Zealand,  Bermuda, China, Jamaica, Lebanon, Netherlands, Slovenia, Singapore
Navitas Naturals Organic Sprouted Chia Powder, 8 oz (227g) package; Omega Fatty Acids, Protein, dietary Fiber.  UPC 858847000369;    Navitas Naturals,  Novato, CA 94949
All Best buy dates up to and including 11/22/2015.
Data obtained from interviews of patients in a multistate outbreak of Salmonella Newport  show Chia Products as the common food consumed
Navitas Naturals Omega Blend Sprouted Smoothie Mix,  8 oz. (227g) package; Dietary Fiber, Raw, Sprouted.  UPC 858847000314;  Also packaged for Williams Sonoma Omega Smoothie Mixer;  SKU 506436    Navitas Naturals,  Novato, CA
All best buy dates up to and including 11/05/2015 Navitas Brand and All best buy datess up to and including OC 2015. for Williams Sonoma brand.
William & Sonoma Navitas Naturals brand Omega 3  Smoothie Mixer,  8 oz. (227g) package; Dietary Fiber, Raw, Sprouted.
All best buy dates up to and including OC 2015
US Nationwide Distribution in the state of California
DISCOVERY ELBOW, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY.   Product Usage:  Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances,hinge components. Components are available in a variety of surface finished including bone coat (a thin layer of titanium plasma spray), porous titanium plasma spray and lnterlok finish.
Surface finish is different than specified.  The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast.  The patient may experience pain requiring surgical intervention.
Oceans Cuisine brand CRAB STUFFING WITH REAL CRABMEAT, NET WEIGHT 3 LBS. (48 oz.) UPC 7 30692 00031 5, PRODUCT OF USA --- PACKED BY: OCEANS CUISINE LTD. FARMINGDALE, NY 11735 --- The product is packaged in plastic tub containers, 2 x 3 lb. containers per case
The crab stuffing is potentially contaminated with Listeria monocytogenes from the raw material (frozen minced crab meat).
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode.    Designed for use in physical therapy, rehabilitation, and pain relief applications.
Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
Worldwide Distribution - Nationwide and the countries of  Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202   The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:  as an aid in the diagnosis of congestive heart failure (also referred to as heart failure)  as an aid in the assessment of severity of congestive heart failure  for the risk stratification of patients with acute coronary syndromes  for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.
Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4.  This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.
GreenSmoothieGirl TriOmega Superfood, GreenSmoothieGirl Sprouted Ground TriIOmega Superfood, Packaged in metalized resealable standup pouches in 1-pound units
The products contain Organic Sprouted Chia Powder that may be contaminated with Salmonella.
RT-5100 Refractor and RT-3100 Refractor;   Distributed by MARCO Opthalmic:  Manufactured by NIDEK CO., Ltd., Aichi, Japan.    Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.
RT-5100 and RT-3100, various serial numbers.
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.
Spacelabs Healthcare Qube Compact Monitor, Model 91390.   Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.
Dark Old Fashioned Sponge Candy, sold under the following brand and sizes:  1.  Eillien's in Net Wt. 6 oz (170g) UPC 34952-12994, 10 oz. (284g) UPC 34952-56927, 12 oz. (340g) UPC 34952-57307.   2.  Blain's Farm & Fleet Net Wt. 14oz. (397g), UPC 34952-81171  3.  Mae's Corner Market Net Wt. 14oz. (397g) UPC 34952-41075, 1 lb. 8 oz. (680g) UPC 34952-41098, and Premium Party Tray, Net Wt. 58.5 oz.(1687g) UPC 34952-41324.    5.  Mrs. Kimball's Candy Shoppe, Net Wt 13 oz(369g) PCA3-13956.  6.  Piggly Wiggly Net Wt. 10 oz. (284g) UPC 34952-58138, and 12 oz. (340g) 34952-57477
Eillien's Candies is recalling Dark Old Fashioned Sponge Candy because it contains undeclared milk.
Distributed in the states of FL, TX, and NY.
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope Intuitive Surgical Inc.
In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope Intuitive Surgical Inc.
Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219  SMN: 10310026    Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments
Kit Lot Number: 454779 Exp. Date: 28 February, 2015
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
Gouda Cheese wheels, Whole Wheels 10 lbs and Half Wheels 5 lbs., packaged under the the brand names: Mountain Gouda and Smiths Farmstand
Product contaminated with Listeria monocytogenes
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.
Ingenia 3.0T R5, magnetic resonance imaging system.
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Ingenia 1.5T R5, magnetic resonance imaging system.
Ingenia 3.0T, magnetic resonance imaging system.
Ingenia 1.5T, magnetic resonance imaging system.