Domestic: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MA, MD, MI, MN, MS, MD, MT, NC, NH, NJ, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, Foreign accounts: Aurba, Canada, Santo Domingo.
Healthwise, Protein Chips,  Barbecue Crunch, Net Weight 1.2 ounces (34 grams), Distributed by Nutritional Resources, Inc., Grovetown, GA 30813.
Foreign matter (plastic) was observed in the product.
UPC 03447  02385, Manufacture lot code: Oct 1316F  (stamped on the rear of the bag).
Stryker Medical Division of Stryker Corporation
Distribution US nationwide, Canada, and Mexico.
S3 MedSurg Bed, Model 3005.	Stryker Medical
CPU board failures cause fowler (backrest) electronic controls to stop working.
US Nationwide Distribution including  DC and  PR.  Internationally Canada.
The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.
Junction Boxes,     Product Usage:  The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Software defect causing intermittently slow response of Host.
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Software issues found in  v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
Ingenuity Core128  Model No. 728323; To produce cross-sectional images of the body.
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Software issues found in software versions  v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Brilliance iCT,  Model No. 728306; To produce cross-sectional images of the body.
Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.
U.S. distribution nationwide.     No foreign distribution.
Cafe Favorites  Oven Roasted Turkey Breast Sub  Code #C02284/02284
Integrated Food Service  Chicken Hot Dog   on a Whole Grain Bun  Code #941500
Integrated Food Service  Turkey Ham & Cheese Sandwich   on a Whole Grain Knot Roll  Code #130008/C13008
Integrated Food Service  Submarine on a French Roll  Turkey Bolo, Turkey Salami and Cheese on a Whole Grain French Roll  Code #C14001/140001
Integrated Food Service  Turkey Bologna & Cheese Sandwich  Turkey Bologna on a whole Grain French Roll  Code #C12001/120001
Integrated Food Service  Chicken Double Dogs  on Whole Grain Buns  Code #809021
Integrated Food Service  Chicken Patty Sandwich  Chicken Patty on a Whole Grain Bun  Code #400003
Integrated Food Service  Egg & Cheese Bagel Thin Sandwich  Code #C38004/380004
Integrated Food Service  Bean & Cheese Chalupa-Bulk  Code #C82705/827005
Integrated Food Service  Chili Cheese Dog  on Whole Grain Buns  Code #809022
Integrated Food Service  Beef Sausage Sandwich  Beef Sausage Patty on a Whole Grain Hawaiian Bun  Code #990018
Cafe Favorites  Italian Deli Flatz  Code #C22548/22548
Integrated Food Service  All America Burger  Beef Patty on a Whole Grain Bun  Code #470007
Integrated Food Service  Turkey Breast Combo on a Whole Grain Knot Roll  Code #C15008/150008
Integrated Food Service  Turkey Sausage & Cheese Bagel Thin Sandwich  Code #809013
Integrated Food Service  Chili Cheese Dog  Whole Grain Hot Dog Bun, Chicken Frank, Chili Sauce and Reduced Sodium Reduced Fat American Cheese  Code #C95150/951500
Integrated Food Service  Original Wienerschnitzel  Chili Cheese Dog  All Meat Hot Dog with Chili & Cheese on a Whole Grain Hot Dog  Code #C96100/960000
Cafe Favorites  Oven Roasted Turkey Breast & Cheese Deli Flatz-IW  Code #C22348/22348
Integrated Food Service  Italian Submarine Sandwich  Code #C140004/C14004
Cafe Favorites  Turkey Ham, Egg & Cheese Sunrise Twist  Code #C51140/51140
Integrated Food Service  Turkey Breast & Cheese Sandwich  on a Whole Grain French Roll  Code #C16001/160001
Integrated Food Service  Chicken Little Sliders-Wrapped  Code #809050
Integrated Food Service  Turkey Ham & Cheese Sandwich  Code #C13001/130001
Integrated Food Service  BBQ Rib Sandwich  BBQ Rib Beef Patty on a Whole Grain Roll  Code #460007
Cafe Favorites  Turkey Sausage & Cheese Sunrise Twist  Code #C52140/52140
Integrated Food Service  Submarine Sandwich on a Whole Grain Ciabatta Roll  Code #C14006/140006
Cafe Favorites  Cold Cut Combo on a Whole Grain Knot Roll  Code #C02372/02372
Integrated Food Service  Beef Sausage & Cheese on a Mini Bagel  Code #809016/C80916-CH  Code #C80916
Integrated Food Service  Turkey Breast & Cheese Sandwich  on a Whole Grain Ciabatta Roll  Code #C16006/160006
Cafe Favorites  Turkey Ham & Cheese Deli Flatz  Code #C22148/22148
Cafe Favorites  Turkey Ham & Cheese Melt on a Knot Roll  Code #C02172/02172
Integrated Food Service  Cheeseburger Sliders  Mini Slider Beef Patty and Cheese on a Whole Grain Bun  Code #470220/C47220-CH
Cafe Favorites  Turkey Ham & Cheese Submarine  Code #C02184/02184
Integrated Food Service  Low Sodium, Reduced Fat   Chili Cheese Dog  Chicken Hot Dog with Chili & Cheese on a Whole Grain Hot Dog Bun  Code #C95200/952000
Cafe Favorites  Oven Roasted Turkey Breast & Cheese Melt on Knot Roll  Code #C02272/02272
Integrated Food Service  Turkey Ham & Cheese Sandwich   on a Whole Grain Hawaiian Bun  Code #130018/C13018
Super Sub on a Whole Grain Hoagie-IW  Code #C02384/02384
Integrated Food Service  All American Cheese Burger  Beef Patty and Cheese on a Whole Grain Bun  Code #471007/C47107-CH
Integrated Food Service  Teriyaki Burger  Beef Patty on a Whole Grain Hawaiian Bun  Code #C48008
Products was distributed to the southern midwest and central south including the states of AR, OK, IA, IL, KS, MO, and TX.
Williams Chipotle Chili Seasoning, Net Wt. 1 1/8 OZ. (32 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.
Chili and taco seasoning products contain an ingredient which was recalled for potentially containing undeclared wheat allergen. Testing revealed the presence of gluten. Wheat is not declared on the label.
Williams Chipotle Taco Seasoning, Net Wt. 1 1/4 OZ. (35.4 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.
Products were sold in the following states: AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN & VA.    Products were also shipped to the following countries: Albania, ALGERIA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Cape Verde, Chile, China, Colombia, Congo, Democratic, Costa Rica, Cyprus, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, India, INDONESIA, Ireland, Italy, Japan, Jordan, Latvia, Lebanon, Libyan Arab Jamahiri, Lithuania, Malawi, Mali, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Nigeria, Oman, Palestine, Paraguay, Philippines, Poland, Romania, Russia, Senegal, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Kingdom, Venezuela, Viet Nam & Zambia.
MX 16-slice SKD whole body computed tomography X-ray system.  Imaging diagnostic tool.
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, manufactured without additive solution, was distributed.
Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Worldwide Distribution -- USA, U.A.E.,  Algeria,  Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland,   Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
All software versions and serial numbers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and  TX, and the country of Canada.
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Distributed in the states of FL, PA, NY, MD, CA, and  AZ.
Richard Allan Scientific 10% Neutral Buffered Formalin,  Part Number: 53901 and 561201  Item 53901 90ml bottle, 125 per case;  Item 561201 120ml bottle, 75 per case.
potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown  whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the  outcome would be risk of false positive or false negative test results which may lead to serious  injury. There is the possibility the patient may need to be re-biopsied.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC,  TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.
Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
The rear gradation scale was screen printed upside down on the flowmeter gauge.
lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton.  The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Raw Refrigerated  Cucumbers, 11/9 bushel, 6 count, 12 count, 24 count, in corrugated cardboard cases, Southern Valley Produce Lot 16300705.      (The product was either distributed in original container or were repackaged).
A sample of raw cucumbers tested positive for Salmonella spp.
cones, 32 oz. box, Manufactured by Mister Cookie Face LLC, Lakeland, NJ and Distributed by Aldi, Batavia, IL 60510, UPC 041498191962
Ice Cream Cones are being recalled because they may contain peanuts which are not declared on the allergen statement.
US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
Medivance ArcticGel Neonatal Pad    The pad is designed to fit into an incubator and provide whole body cooling for patients.
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822
Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY,  SPAIN, SWITZERLAND, and UNITED KINGDOM.
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button.  A/C Powered Adjustable Hospital Bed    Product Usage:  Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm.  To date there has been one report of a related injury.
All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER.
Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile,    Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing #  B106952.  One step polishing system for all common dental composites and amalgam.
After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away.  OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
REF/Product ID 634459: Lot UL0843;   REF/Product ID 634458: Lot VL0704;   REF/Product ID 634464: Lot VL0705.
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S    Product Usage:  Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.
Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.
Blood product, in which quality control and distribution of product did not meet specifications, was distributed.
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled  Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255  Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
US Nationwide Distribution in the states of FL, KS and  WV.
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365    Product Usage:  A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.
Cracks may occur at the 15mm and 22mm ISO female connector.
AZ, CA, IL, IN, MN, OH, PA and WI.  Outside the US to include:  Canada
Snack Factory Original Pretzel Crisps, Thin, Crunchy Pretzel Crackers.    Made in a facility that processes Milk and Soy.  Distributed by:  Snack Factory, PO Box 6917, Hanover, PA  17331    Sold in the following sizes and UPC codes:    12 ct / 116 oz.      Net Wt 26 oz (l lb 10 oz.) 737g, UPC 49508-00692,   Net. Wt. 30 oz. (1 lb. 14 oz.) 850 g, UPC 49508-25040
Baptista's Bakery is recalling The Snack Factory 30 oz. Original Pretzel Crisps due to undeclared milk, because it may contain seasoned pretzel crisps which utilize dairy in their topical seasoning application.
16 oz.:  Item Code 110608, Lot Code:  BB070165A 03, Best By Date 07-01-17;     26 oz.:  Item Code 110692, Lot Code:  BB070162A 03, Best By Date 07-01-17;     30 oz.:  Item Code 108105, Best By Date 07-01-17.
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Apheresis product, collected from a donor with a HTLV repeatedly reactive donation was distributed.
US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
STAPLER 30, IS4000, model number 470430;    Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of  anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a  Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
CURVED-TIP STAPLER 30,IS4000, model number  470530;    Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of  anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
Hitachi Scenaria Computed Tomography System  Hitachi Medical Systems America, Twinsburg, OH 44087
The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,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,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic  AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
ARTIS ZEE AND ZEEGO, system, x-ray, angiographic  AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM,  interventional fluoroscopic x-ray system22    AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA.
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices    The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius System - 2.4 mm Titanium LCP Radial Head Plate Set - Titanium Modular Mini Fragment LCP System - 2.4 mm Titanium Variable Angle LCP Distal Radius System - 2.7 mm/3.5 mm Titanium Distal Fibula Plate System
It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft.  This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.
Lot Number: 9942217  Part Number: 412.812
Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Japan, Netherlands, Algeria, Australia, Brazil, Chile, China, France, Guatemala, Hong Kong, Italy, New Zealand, Pakistan, Philippines, Singapore, Taiwan, and United Kingdom.
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed  conventionally.
Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process.  This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode.
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
US Distribution to the states of : FL, VA, OK, CO, DC and IN.
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, and the countries of Angola, Argentina, Austria, Australia, Austria, Botswana, Brazil, Burkina Faso, Cambodia, China, Columbia, Djibouti Antilles, Estonia, Georgia, Germany, Greece, India, Israel, Italy, Kuwait, Latvia, Malaysia, Mexico, Netherlands, Poland, Qatar, Russia, Senegal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Zambia, and Zimbabwe
NucliSENS easyMAG Magnetic Silica    The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals.  They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous.  These products are intended for in vitro diagnostic use by healthcare professionals only.
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Lots - Z017BB1MS, Z017BF1MS, Z017CA1MS, Z017BE1MS, Z017CC1MS, Z017CD1MS, Z017CH1MS, Z017BD1MS, Z017DB1MS, Z017BA1MS, Z017CF1MS, Z017CE1MS, Z017CG1MS, Z017DA1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017KF1MS, Z017KG1MS, Z017KH1MS
Nationwide, Puerto Rico, and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, Venezuela.
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on Estradiol results, obtained from postmenopausal females taking Fulvestrant.
Lot numbers: 1470 (expiry date 02-Aug-16); 1480 (expiry date 05-Aug-16), 1490 (expiry date 10-Oct-16), 1500 (expiry date 10-Oct-16), 1510 (expiry date 01-Nov-16), 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17), 1548 (expiry date 09-Mar-17), 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)
Apheresis product, collected from a donor who had not had an annual physical exam performed, was distributed.
Blood product mislabeled with incorrect Rh antigen type was distributed.
The software was distributed to medical facilities nationwide.  Government distribution was made to MN.  Foreign distribution was made to Australia and to the United Kingdom.  There was no military distribution.
Merge PACS software.  Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Worldwide Distribution --  USA and Australia.
Merge PACS software.  The firm name on the label is Merge Healthcare, Inc., Hartland, WI.    Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
49 sites potentially have the affected versions
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
, id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit.    The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
Incorrect drill protocol in the Instructions for Use (IFU)
Becton, Dickinson and Company, BD Biosciences
Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD);  Catalog number 340383.  Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide.      Hematology:  BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte  subsets in erythrocyte-lysed whole blood.
Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.
Blood product, collected from a donor who was allowed to donate without a current physical, was distributed.
Penrose-St Francis Health Services Blood Bank
Blood product, for which Chagas Disease testing was not performed, was distributed.
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.