Domestic: IN, IL, MI, MN    Foreign: None
Chicken Tender Chunks  5 lb bag, 6- 5 lb bags/case, and 10 lb bag
6000 lbs. in the form of 200 x 5lb. bags and 500 x 10 lb. bags combined product
Listeria monocytogenes was found in retail surveillance sample collected by the State of Michigan.  The firm was notified and initiated a recall and contacted customers via telephone, press release and letters to be issued.
All UPC Package Codes; Manufacture Date: 05/06/2014 to 01/7/2015
Duckling Tender Chunks  5 lb bag, 6- 5 lb bags/case, and 10 lb bag
The product may be contaminated with Listeria monocytogenes and Salmonella.  L. mono and Salmonella were detected in other varieties processed at the firm in retail surveillance samples collected by the State of Michigan.  The firm was notified and initiated a recall and contacted customers via telephone, press release and letters starting on 1/13/2015.
Beef Tender Chunks  5 lb bag, 6- 5 lb bags/case, and 10 lb bag
Listeria monocytogenes and Salmonella was found in retail surveillance sample collected by the State of Michigan.  The firm was notified and initiated a recall and contacted customers via telephone, press release and letters starting on 1/13/2015.
Product was shipped to the following states: OH, FL, WV
BINO'S ITALIAN SWEET PEPPERS Ingredients: Bell peppers, onions, vinegar, garlic, sugar, tomato sauce, tomato puree, salt and olive oil. NET WT  16 oz UPC 8 67752 00012 8 NET WT 32 oz UPC 8 67752 00010 4
The firm was manufacturing acidified foods without a license.
HERBERT'S chow-chow Original New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
Keim's Garden Harvest pickled beets Ingredients: red beets, water, sugar, vinegar, spices, salt. Manufactured by: Keim's Garden Harvest  (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 14 oz UPC 6 09722 32336 9, 32 oz UPC 6 09722 32339 0
Kiem's Garden Harvest corn relish 1 PT (14 oz 397g) Ingredients: corn, peppers, celery***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH 45692 Mild UPC 6 09722 32335 2 Hot UPC 6 09722 32349 9
Keim's Garden Harvest pickled zesty mustard eggs Ingredients: eggs, water, vinegar, sugar, salt***yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83464 9, 32 oz 6 09788 83459 5
A BIT OF A BITE SALSA HEINEY HOT SALSA NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95415 0
Barney's Hot Peppers 16 oz (443 ml) Ingredients: Hot Peppers, Canola Oil, Garlic, Oregano, Salt, Acidic Calcium Sulfate Distributed by: Barney's Hot Peppers 2061 Elm Road Warren, Ohio 44483 330-964-2922 UPC # 7 01807 99994 7
Kiem's Garden Harvest sweet & tangy citrus salsa 1 PT (14 oz 397g) Ingredients:tomatoes, onions***lemon juice concentrate, lime juice concentrate***Manufactured by: Keim's Garden Harvest (937) 515-4518 2232 Honeysuckle Lane Wellston, OH 45692 UPC 6 09722 32346 8
SEASONAL SELECTIONS SUGAR & SPICE GOURMET BEETS NET WT 16 OZ (1 lb) 453g INGREDIENTS: Beets, Vinegar, Sugar, Whole Allspice, Salt, Cinnamon Sticks SEASONAL SELECTIONS P.O. BOX 251 Waynesville, OH 45060 UPC 8 57596 00308 9
DUTCH COUNTRY KETTLES HOMEMADE Pickled Beets  Ingredients: Beets, Water, Vinegar, Sugar, Salt. Dutch Country Kettles 6732 Pavey Road. Leesburg, OH 45135 1-937-780-6718 1 Pint (1 lb. 3oz) 538g UPC 6 98241 12224 9 & 1 Quart (32 oz) 907g UPC 6 98241 14444 9
Keim's Garden Harvest pickled spicy jalapeno eggs Ingredients: eggs, water, vinegar, sugar, salt, spices, peppers, pepper oil, yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83460 1, 1 QT (32 oz 946 ML) 6 09788 83458 8
Keim's Garden Harvest pickled white eggs Ingredients: eggs, water, vinegar, sugar, salt. Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83461 8, 32 oz 6 09788 83456 4
A BIT OF A BITE SALSA MELISSA MEDIUM NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS, FRESH HABANERO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95416 7
ROASTED MEDITERRANEAN PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***UPC 8 11975 01109 6
ROASTED MEDITERRANEAN SPICY PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***Habanero Pepper. UPC 8 63131 00011 6
Abruzzi's Hot Peppers in oil 15 Fl Oz (444 ml) Manufactured For: Abruzzis Hot Peppers, LLC, 371 Marwood Drive, S.E. Warren, Ohio 44484  (330) 883-7933 UPC 8 51071 00500 1
House MADE Sriracha Sauce NET WT. 8 oz (237 mL) INGREDIENTS: THAI CHILIES, DISTILLED VINEGAR, SUGARS, GARLIC, MOLASSES, KOSHER SALT. www.housemadesriracha.com UPC 6 12524 99999 1
Cleveland Pickle Original Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0
PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Uncle Joe's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot Wax Peppers, Garlic, Vinegar, All Natural Ketchup, Sugar, Canola Oil, pattyspeppers.com UPC 7 48252 07486 7
HERBERT'S chow-chow Hot New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
A BIT OF A BITE SALSA SARAH SWEET NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95417 4
A BIT OF A BITE SALSA THREE SISTERS NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, ORGANIC BLACK BEANS, FRESH CORN***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95418 1
RJ's DIAVOLO SAUCE WITH PEPPERS 25 oz INGREDIENTS: ground unpeeled vine-ripened tomatoes, tomato puree, tomato past, Hungarian hot wax peppers, Cubanelle peppers, fresh sweet onions, fresh garlic,***Manufactured for: RJ's Pepper Pantry Warren, OH 44484 Phone 330-765-2863 Mild UPC 8 53827 00403 0, Medium Hot UPC 8 5327 00404 7, Hot UPC 8 53827 00405 4
Keim's Garden Harvest tomato salsa 1 PT (14 oz 397g) Ingredients: tomatoes, onions, peppers, herbs***Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 mild UPC 6 09722 32345 1 medium UPC 6 09722 32343 7, hot UPC 6 09722 32344 4
Mild Lot # 106295, Medium All Codes, Hot Lot #: 86305
Kiem's Garden Harvest black bean salsa 1 PT (14 oz 397g) Ingredients: beans, corn, tomato***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH UPC 6 09722 32347 5
Keim's Garden Harvest pickled red beet eggs Ingredients: eggs, water, vinegar, sugar, salt***beet juice, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83455 7, 32 oz 6 09788 83457 4
Cleveland Pickle Spicy Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Habanero Peppers***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0
BINO'S ITALIAN HOT PEPPERS Ingredients: Hungarian hot peppers w/seeds, onions, vinegar, garlic, sugar, Bell peppers, tomato sauce, tomato puree, salt and olive oil. NET WT 16 oz UPC 8 67752 00013 5  NET WT 32 oz UPC 8 67752 00011 1
PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Mom's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot and Sweet Peppers, Garlic, Canola Oil, Vinegar, Salt, Oregano. pattspeppers.com UPC 7 48252 07478 2
HERBERT'S chow-chow Mild New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
RJ's PEPPERS IN OIL 12 OZ. (340G) INGREDIENTS: PEPPERS, CANOLA OIL***Manufactured for: RJ's Pepper Pantry Warren, OH 4484 Phone: 330-766-2863 Mild UPC 8 53827 00401 6, Medium Hot UPC 8 53827 00402 3, Hot UPC 8 53827 00400 9
Worldwide distribution.  US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo),  9mm, 11mm, 13mm, 15mm, and 17mm
PMMA is listed as a material on the label but the product does not contain PMMA.
Mercury Enterprises, Inc. dba Mercury Medical
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirate, and United Kingdom..
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit.  The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
Smoked Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67262 9
Product has the potential to be contaminated with Clostridium botulinum.
Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.
Peppered & Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7 and 7 48252 67302 2.
Peppered & Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67212 4
Smoked Jalapeno Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67352 7
Smoked Garlic Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3
Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67342 8
Smoked Garlic Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67362 6
Smoked Jalapeno Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67392 3
Fancy Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67292 6
Fancy Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67412 8
Smoked Catfish, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67252 0
Peppered & Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67332 9
Smoked Jalapeno Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67312 1
Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7
Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3
Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67242 1
Peppered & Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67232 2
Smoked Spring Chinook, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67402 9, UPC 7 48252 67382 4, UPC 7 48252 67372 5
Smoked Walleye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 94504 39610 2
Smoked Jalapeno Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67272 8
Worldwide Distribution - US Nationwide and the countries of  Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and  Venezuela.
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD.    Product  Usage:  The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
Software Version 3.2 and below; Serial Numbers J46001001 -J4600636
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD.    Product  Usage:  For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Software Version 3.2 and below; Serial Numbers J56000024 - J56002309
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD.    Product  Usage:  The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).
VITROS 5,1: Domestic - 932, Foreign - 1245; 5,1 Refurbished: Domestic - 63; Foreign - 153
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD.    Product  Usage:  For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
Software Version 3.2 and below; Serial Numbers J36000012 - 36000879
US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator Model 106
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.
US Distribution to states of: TN and NJ.
NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set     A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.
Blood foaming was found during evaluation of the product.
Mi Tienda Tostaditas Botoneras Rojas packaged in bag
Mi Tienda Tostada Siveria Large Tostada packaged in bag
Mi Tienda Masa Preparada By the Pound packaged in bag
Pasteurized Donor Human Milk, Frozen then thawed. Product is packaged in 4 oz. glass bottle with metal lid and plastic seal.     A bar code is present on each label but there is NO UPC codes.
Report by recipient hospital found a foreign particle in a single bottle of mother's milk once thawed and opened.  Finder reported the particle was a fruit fly or sugar ant.
Batch number 001757-1.  Expiration date: 04/04/2016    The number reflects the pool of donor milk created (001757) and the single batch created from the pool(001757-1)
Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain,  Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.    .
0 deg, 8mm Endoscope, IS4000:  Model numbers: 470026-34, 470026-40, 470026-41.    General and Plastic Surgery:  The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments.  It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.
30 deg, 8mm Endoscope, IS4000:  Model numbers: 470027-34, 470027-40, 470027-41.    General and Plastic Surgery:  The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
Worldwide distribution.  US nationwide including OH, MO, AZ, AL, CA, FL, SC, GA, and PA; Spain, France, United Kingdom, Germany, Switzerland, Singapore, Russia, Turkey, and Ecuador.
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.
Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK  74011.
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Brain Metastases version 1.0.0    Model/catalogue number       Description  21702-04                     ELEMENTS AUT. BRAIN METASTASES PLAN INST  21703-01                     ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE  21703-02                     ELEMENTS ADAPT HYB SURG ANALYSIS INST  21702                       ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-12                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-36                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-60                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21703                       ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-12                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-36                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-60                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21713                       ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS  21722                       ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-12                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-36                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-60                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21723                       ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-12                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-36                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-60                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21732                       ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M
Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0
Adaptive Hybrid Surgery Analysis version 1.0.0    Model/catalogue number       Description  21702-04                     ELEMENTS AUT. BRAIN METASTASES PLAN INST  21703-01                     ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE  21703-02                     ELEMENTS ADAPT HYB SURG ANALYSIS INST  21702                       ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-12                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-36                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-60                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21703                       ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-12                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-36                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-60                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21713                       ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS  21722                       ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-12                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-36                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-60                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21723                       ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-12                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-36                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-60                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21732                       ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M
Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.
Perkin Elmer WIZARD2 10-detector, 1000 samples.  Product Code: 2470-0200, 3470-0200.  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.
Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Perkin Elmer ClWIZARD2 5-detector, 550 samples  Product Code: 2470-0050, 3470-0050.  The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100.  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Perkin Elmer WIZARD2 5-detector, 1000 samples  Product Code: 2470-0150, 3470-0150  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
, 1000 samples.  Product Code: 2480-0010  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046.  Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
The trial shell mating feature on the broach is undersized.
Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI.
Medrad Source Administration Sets, Catalog number INT CSS.  For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Sweet Leaf  All Natural Peach Iced Tea , 16 oz glass bottle  UPC: 6-51538-06704-3
Sweet Leaf Organic Tea Mint & Honey, 16 oz glass bottle  UPC: 6-51538-06701-2
Sweet Leaf Organic Original Sweet Tea,  16 oz glass bottle  UPC: 6-51538-06700-5
Sweet Leaf All Natural Citrus Green Tea, 16 oz glass bottle  UPC: 6-51538-06720-3
Sweet Leaf Organic Raspberry Iced Tea, 16 oz glass bottle  UPC: 6-51538-06703-6
Sweet Leaf Organic Half and Half Lemonade Tea, 16 oz glass bottle  UPC: 6-51538-06708-1
US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI.    OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.
Zimmer,  Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3).     UDI Number 889024328952
Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
2101 E. Military Hwy, McAllen, TX, 78503
PICOSITO Jalapenos Distributed by: Sweet Superior Fruit LTD. CO. PRODUCE OF MEXICO
Roasted Seasoned Himego Fish    Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag.
Snack Depot is recalling himego fish because it was mislabeled and misidentified.
Roasted Seasoned Himego Fish (spicy)    Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag.
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities.    The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
MOVES System Lithium Polymer Batteries    The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs    Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236    Indicated for use in patients who require surgery of the extremities.
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Blood products, collected from a donor who subsequently tested HIV reactive, were distributed.
Becton, Dickinson and Company, BD Biosciences
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation.  The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV  and Internationally to Canada, and Japan.
Ergon 2 Articulating Equipment Boom Monitor Brackets    mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms
The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket.  A display interface falling from its mounting location may result in injury to the patient or provider.
Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH.  VESA plates distributed from 09/26/08 to 04/30/13.
Platelet Pheresis products, labled as leuko reduced, in which WBC testing was not performed, were distributed.
W158015801954 (double collection); W158015801956 (double collection); W158015801957 (double collection)
US nationwide distribution including AZ, CA, CO, GA, OH, and TN.
Model NuCARTGN.  The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors.  It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.
The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release and detach.
Blood product, collected from a donor with a history of reactive results for HCV, was distributed.
CA, CO, CT, IA, IL, IN, KY, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, TN, WA, WI
TWININGS OF London ENGLISH BREAKFAST BLACK TEA DECAFFEINATED, 12-0.11OZ (3.2g)/ EA NET WT 1.34 oz (38g), UPC 00070177513078
Twinings English Breakfast Black Tea 12ct Kcups, were packaged in cartons stating Twinings English Breakfast Black Tea Decaffeinated.
Lot #: 105657B- Best Before Date: 04/28/17
Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.
iChem 10 SG Urine Chemistry Strips, PN 800-7005.    Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
Worldwide Distribution-US including the states of CA, NY, PA, AL, FL, GA, ID, WI, MO, SC, NC, and ME, and the countries of Brazil, Dominican Republic, Taiwan, China, Uruguay, Australia, Japan, Malaysia, India, Belgium, France, Italy, Netherlands, Poland, United Arab Emirates, and Canada.
Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length;  Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length.    Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Product on the package label did not match what was inside the package.    The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate  Straight 11 Holes 144mm Length  Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate  8 Holes 105mm Length.    Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.
US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw    The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
DCI Donor Services Tissue Services Division
Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.