Kruse's Perfection - Western Blend Horse Feed; Promise  Formula K66505, Lot 5251, 50 lb. bag packages (22.68 kg)    UPC 000005251    Manufactured by:  O.H. Kruse Grain and Milling, Goshen, CA
One lot of Western Forage Blend for horses is being recalled due to positive results for monensin quick test and three horse deaths.
AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
Product contained an incorrect substrate.
Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016
Phosphoric Acid, 75% and 85% Food Grade (Brand Name PRAYPHOS PPA 75% FG and PRAYPHOS PPA 85% FG)
Potential contamination with trace levels of 1-methylethyl benze (more commonly known as cumene).
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Daily Chef Food Service Pure Canola Oil (Aceite de Canola Para Ensaladas), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's Inc., Bentonville, AR 72716, UPC 0 78742 06149 8
The presence of a foreign material inside jugs of Bunge Vegetable Oil.
Hooters Creamy Liquid soybean Frying Oil, Net Wt 35 lb (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 73746 8
Old World Clear Canola Liquid Frying Oil (Aceite de Canola Para Freir Liquido y Transparente), Net Wt.35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 70021 9
Taco Bell Liquid Canola Frying Oil, 35 lb., (15.88 kg), Packaged Exclusively for use by Taco Bell and its franchisees. Taco Bell Corp, Irvine, CA 92618
Old World Canola Oil (Aceite de Canola), Net Wt. 35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 70020 2
Nutra-Clear NT Ultra - Bunge Canola Deep Frying Oil (High Stability), 35 lb., (15.88 kg), MFD in USA by: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 72477 2
Bunge Soy Clear Fry Oil OU, 35 lb., Manufactured by: Bunge Oils, Inc. Kearny, NJ 07032, UPC 00078684692026
Old World Soybean Oil (Aceite de Soja), Net Wt.35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 70011 0
Smart Source Clear Soybean Frying Oil (Aceite de Soya Transparente Para Freir), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 13046 6
Katy's Kitchen Soybean Salad Oil (Soya Aceite Para Ensalada), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, Product of USA/Producto de EE.UU., UPC 0 08 22486 13034 3
Smart Source Creamy Soybean Frying Oil (Aceite de Soja Cremosa Para Freir), Net Wt./Peso Neto, 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, Product of USA/Producto de EE.UU., UPC 0 08 22486 13045 9
EB Golden Fry Clear Liquid Shortening, 35 lbs. (15.88 kg), Distributed By: EB Express Provisions, Inc., 181-191 Vanderpool Street, Newark, NJ 07114, UPC 0 00 78684 73630 0
Harvest Value Clear Vegetable Frying Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 00302 1
Daily Chef Food Service Pure Soybean Oil (Aceite de Soya), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's West Inc., Bentonville, AR 72716, UPC 0 78742 06151 1
Bunge Clear Liquid Canola Frying Oil (Aceite de Canola para freir liquido y transparente), Net Wt 35 lb (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 69266 8
Yum Canola Frying Oil Blend, Net Wt., 35 lbs. (15.88 kg), Packaged Exclusively for use by Yum! Brands Global Restaurants, Yum Brands, Louisville, KY 40232
Bunge Creamy Soy Liquid Frying Oil (Aceite de Soja Para Freir Liquido y Cremosa), Net Wt. 35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 73353 8
Smart Source Canola Salad Oil (Aceite de Canola Para Ensalada), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 17655 6
Bunge Corn Oil (Aceite de maiz), Net Wt 35 lb (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 69118 0
Harvest Value Canola Salad Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 02454 5
Harvest Value Canola Liquid Frying Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 01988 6
Daily Chef Food Service Pure Clear Frying Oil (Aceite Transparente Para Freir), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's West Inc., Bentonville, AR 72716, UPC 0 78742 06148 1
Nathan's Pure Corn Oil, Net Weight 35 lb (15.88 kg), Packed Exclusively for: Nathan's, General Offices: One Jericho Plaza, Jericho, NY 11753, UPC 0 07 16071 99955 5
, Net Wt 35 lb (17.4 Liter), Distributed By. IAS International American Supermarkets, 226 Old New Brunswick Road, Piscataway, NJ 08854, Mfd By: Bunge, Bradley, IL 60915, UPC 0 00 78684 69024 4
Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway,  Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575.    For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02.   Manufactured for Onpharma Inc. Los Gratos, CA 95030    The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use.  However, the current labeling and IFU does not stipulate this time period.
Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.
shielded  IV catheter (0.7 mm x 14 mm) made of FEP polymer    catalog number 381720
The device may have a defect in the catheter. In some instances this defect could result in catheter  separation or breakage.
Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
Diamedix Is-EBV-EA-D IgG Test Kit     Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Lot # 51104, Catalog # 720-640 Expiration Date August 31, 2015
Diamedix Is-EBV-VCA IgG Test Kit     Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Lot # 30804, Catalog # 720-600 Expiration Date April 30, 2015
Diamedix Is-Mumps IgG Test Kit     Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Lot # 20804, Catalog # 720-540. Expiration Date August 31, 2015
Manischewitz Pistachio Orange Macaroons 10 oz.     Distributed by: The Manischewitz Company Newark, NJ 07105  Product of USA        UPC 0-7270000119-6
Manischewitz Pistachio Orange macaroons may contain pistachio shell fragments.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
US Distribution in the states of KY and TX.
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD    Product Usage:  The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD     Product  Usage:  The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705
Domestic: Al, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, LA, MD, ME, MI, MN, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TX, VA, WA, WI    Foreign, VA./DOD: None
Colby Jack cheese, 8 oz. and 16 oz, Vacuumed plastic pouches
Michigan State University Dairy is conducting a voluntary recall of Colby Jack cheese due to the potential for metal fragments to be present in the finished products.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) All Acne Filters manufactured and Distributed Between: August 04 2015 and November 06 2015
Blood product, collected from a donor with no documentation of general appearance or arm inspection, was distributed.
Blood product, collected from a donor whose suitability was not adequately determined, was distributed.
United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay
Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
The product has potential to leak beyond their design specification.
Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
but no nuts/tree nuts are listed in the ingredient statement.
Undeclared hazelnuts due to miss-packaging by the foreign manufacturer.
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231.    Mass spectrometers for in vitro diagnostic use only.
Under certain conditions, mass spectrometers may report incorrect quantitative results.
Mislabeled plasma products were distributed.
Blood products, collected from an ineligible donor, were distributed.
Nationwide.  No foreign or govt/VA/military consignees.
Liposomal Magnesium Nutritional Supplement. 6 FL. OZ (180 ml) The product is packaged in a six ounce, plastic, Royalty Bottle, with a 24mm vented flip top lid. item number: DES004Z. Sold under brands DESBIO and Seeking Health
Empirical Labs is recalling Liposomal Magnesium because of the potential for mold contamination.
Alfalfa Sprout Product***Germinados Campo Verde***San Sebastian, Puerto Rico
Alfalfa sprout product lot is being recalled due to its link to seed lot SAL2-5CF contaminated with Salmonella.
MegaFood  Multi for Women 40+, Multivitamin & Mineral Dietary Supplement packaged in glass bottles  UPC:5149410321 -Packaged 60 tablets;  UPC:5149410322 -Packaged 120 tablets
Multi Vitamin label fails to have  required warning statement for iron and child resistant cap
Item  Number:10321 (60 count) - Lot Numbers: 10321004 & 10321005  Item Number: 10322 (120 count)-Lot Number 10322004
Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
NeuroBlate System SideFire Select  2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01.  NeuroBlate System SideFire  Select Directional Laser Probes are part of the NeuroBlate System.  The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization.  It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.
Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
All unexpired lots of these models are being removed from the market.
Blood product, collected within one year from a donor who travelled to a malarial endemic country, was distributed.
Mislabeled blood product was distributed.
Mixed Fruit (In Light Syrup), Net Wt. 8oz (227g), Bottle Label UPC 0-49022-80896-6, Case UPC 100-49022-80896-3
MW Polar Foods is recalling Nice! Peach Slices and Nice! Mixed Fruit in 8-ounce glass jars due to potential glass in the product.
Sliced Peaches (In Light Syrup), Net Wt. 8oz (227g), Bottle Label UPC 0-49022-80894-2, Case UPC 100-49022-80894-9
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products collected within three years from a donor immigrating from a malarial endemic area, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine
LenSx Laser System.  Indicated for use in patients undergoing cataract surgery and refractive surgery.
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only.  Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
U.S. distribution to the following; CA, TX, CT, CO, GA, NY, CT    No foreign distribution.
Royal Snacks   Jalapeno Pistachio  Royal Size
TRADER JOE'S Apple Cider, NOT FROM CONCENTRATE SHAKE WELL NO PRESERVATIVES 100% JUICE PASTEURIZED.  PERISHABLE, KEEP REFRIGERATED. NET 64 FL OZ (2 QT) 1.89 L. UPC: 0016 4580.
Patulin was found in the apple cider at 63.7 ppb.
NY, RI, ME, MA, VT, OH, MN, IN, KY, MO, ME, SD, CT, IA, NE, WI, NJ
US: OR, MA, IA    OUS: New Zealand, Canada
Organic Green Tea Hojicha, Net 16 kgs,   (bulk product 16 kg boxes with inner liner)
QTrade Teas & Herbs is recalling Organic Green Tea Hojicha  because it has the potential to be contaminated with Salmonella.
Organic Ginger Peach Iced Tea, 100x1oz box, item #60001
QTrade Teas & Herbs is recalling Organic Ginger Root Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.
Organic Coconut Chai Tea Bag Cut (TBC), Net: 25kg
Organic Ginger Root Tea Bag Cut (TBC), 25 kgs
Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Zimmer Plates and Screws (ZPS)   2.7 mm Cortical Screw SelfTapping, 14 mm Length 	47482701401
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Trilogy self-tapping bone screw   Bone screw 4.5x25 selftap	00625004525  Bone screw 4.5x50 selftap	00625004550  Bone screw 6.5x15 selftap	00625006515  Bone screw 6.5x20 selftap	00625006520  Bone screw 6.5x25 selftap	00625006525  Bone screw 6.5x30 selftap	00625006530
ITST   intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length	00225305745
Zimmer Plates and Screws (ZPS)   4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 	47484001200  4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 	47484001400  4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 	47484001600  4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 	47484001800  4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 	47484002000  4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 	47484002200  4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 	47484002600  4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 	47484003001  4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 	47484003200  4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 	47484003600  4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 	47484004000  4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 	47484004500  4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 	47484005000  4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 	47484005500  4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 	47484006000  4.5 mm Cortical Screw SelfTapping, 16 mm Length 	47484501601  4.5 mm Cortical Screw SelfTapping, 18 mm Length 	47484501801  4.5 mm Cortical Screw Self-Tapping, 20 mm Length 	47484502001  4.5 mm Cortical Screw Self-Tapping, 22 mm Length 	47484502201  4.5 mm Cortical Screw SelfTapping, 24 mm Length 	47484502401  4.5 mm Cortical Screw SelfTapping, 26 mm Length 	47484502601  4.5 mm Cortical Screw SelfTapping, 28 mm Length 	47484502801  4.5 mm Cortical Screw SelfTapping, 34 mm Length 	47484503401  4.5 mm Cortical Screw SelfTapping, 38 mm Length 	47484503801  4.5 mm Cortical Screw SelfTapping, 40 mm Length 	47484504001  4.5 mm Cortical Screw SelfTapping, 42 mm Length 	47484504201  4.5 mm Cortical Screw SelfTapping, 54 mm Length 	47484505401  4.5 mm Cortical Screw Self-Tapping, 58 mm Length 	47484505801  4.5 mm Cortical Screw SelfTapping, 64 mm Length 	47484506401  4.5 mm Cortical Screw SelfTapping, 66 mm Length 	47484506601  4.5 mm Cortical Screw SelfTapping, 68 mm Length 	47484506801  4.5 mm Corti
VersaFx Femoral Fixation System   Hex head compression screw 4.7  mm dia.  2 inch (51 mm) length	47116202400
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length	00225304542  M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length	00225307042
Zimmer Plates and Screws (ZPS)   3.5 mm Cortical Screw SelfTapping, 10 mm Length 	47483501001  3.5 mm Cortical Screw SelfTapping, 14 mm Length 	47483501401  3.5 mm Cortical Screw SelfTapping, 16 mm Length 	47483501601  3.5 mm Cortical Screw SelfTapping, 24 mm Length 	47483502401  3.5 mm Cortical Screw SelfTapping, 30 mm Length 	47483503001  3.5 mm Cortical Screw SelfTapping, 40 mm Length 	47483504001  3.5 mm Cortical Screw SelfTapping, 75 mm Length 	47483507501
Hgp ii acetabular cup bone screw selftap 6.5x15mm	00662406515  Hgp ii acetabular cup bone screw selftap 6.5x20mm	00662406520  Hgp ii acetabular cup bone screw selftap 6.5x25mm	00662406525  Hgp ii acetabular cup bone screw selftap 6.5x35mm	00662406535  Hgp ii acetabular cup bone screw selftap 6.5x55mm	00662406550  Hgp ii acetabular cup bone screw selftap 6.5x60mm	00662406560
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length	47493501801
Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length	00114205020  Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length	00114205036  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length	00114205124  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 28 mm Length	00114205128  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 30 mm Length	00114205130  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 38 mm Length	00114205138  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 48 mm Length	00114205148  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 65 mm Length	00114205165  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 55 mm Length	00114605599  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 60 mm Length	00114606099  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, 32 mm Thread Length, 7.0 mm Diameter, 65 mm Length	00114606532  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 65 mm Length	00114606599  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 12 mm Length	00114205012
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length	47115504507  Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length	47115507507  Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length	47115509007
Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length  	47234702116
Blood Systems, Inc. DBA United Blood Services
Blood product, for which donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor for whom donor suitability was inadequately determined, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Platelet product, not prepared in accordance with specifications, was distributed.
Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS  system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS).      The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
Potential for  the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
All lot numbers manufactured by BioTex are affected for Model Numbers:   T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP  T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP  T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP