Recalling Firm
Inner Health Group, Inc dba Michael's Naturopathic Programs
AccessClosure, Inc., A Cardinal Health Company
Implant Direct Sybron Manufacturing, LLC
Philips Electronics North America Corporation

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.
CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT
Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN,TX, UT, VA, VT, WA, WI, WV, WY Foreign:None VA/DOD: See list below
Nationwide and in the Domincan Republic. No government or military distribution.
Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda
Product was shipped to the following states: IN, KY & OH.
AL, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, NC, OH, OK PA, SC, TN, TX, VA, WV & WI
US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.
Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.
distributed in CA, CO, ID, MD, OR, TX and WA and in Australia, Canada, China, Great Britain, Hong Kong, and India.
2 consignees in Maryland and Ohio. No Canadian/foreign/VA/govt/military.
Domestic: CO, IL Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan, Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong, Philippines, Iran, Brazil, Turkey, United Arab Emirates (UAE), Uruguay
Worldwide Distribution - USA Distribution and to the countries of : AFGHANISTAN, ARGENTINA, AUSTRALIA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GUATEMALA, HONG KONG, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JORDAN, KUWAIT, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, PAKISTAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, Slovakia, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and URUGUAY.
Worldwide Distribution: US (nationwide) including states of: AK , AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and country of: Canada
Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.
Worldwide Distribution - US (nationwide (including Guam and Puerto Rico), and Internationally to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.
The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
US Nationwide distribution in the states of: TN, NC, FL, and PA
Product was shipped to the following states: IA, IL, IN, KY, MI, MN, MO, NC, NE, NJ, OH, PA, SC, TN, VA, WI & WV.
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Worldwide Distribution -- US, Canada, and Colombia.
Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, MI, MO, MT, MS, NC, NE, NM, NV, OH, OR, SC, TN, UT, VA, WA, WV & WY.
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
Worldwide Distribution -- USA, New Zealand, and United Kingdom.
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
USA Distribution to the states of :AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, WI, and Internationally to Canada
Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.
Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.

Product Description
Stella & Chewy's Freeze-Dried Tummy Ticklin' Turkey Dinner for Cats, 12 oz, UPC 186011000663.
Stella & Chewy's Carnivore Crunch Turkey Recipe, 3.25 oz, UPC 186011001103.
Stella & Chewy's Freeze-Dried Salmon & Chicken Dinner for Cats, 12 oz, UPC 186011000403.
Stella & Chewy's Frozen Surf'N Turf Dinner Patties for Dogs, 6 lb, UPC 186011000533.
Stella & Chewy's Freeze-Dried Chick, Chick, Chicken Dinner for Cats, 12 oz, UPC 186011000434.
Stella & Chewy's Frozen Duck Duck Goose Dinner Morsels for Dogs, 4 lb, UPC 186011001394.
Stella & Chewy's Freeze-Dried Tantalizing Turkey Meal Mixers, 18 oz, UPC 186011000229. Freeze-Dried Tantalizing Turkey Meal Mixers, 9 oz, UPC 186011000205.
No UPC code 50 lb bags - Yellow label attached to a brown bag.
UPC 7 13757 96142 4 50 lb bags - Salmon colored label attached to a brown bag.
Stella & Chewy's brand chick chick chicken Dinner Morsels for Cats. Keep Frozen. Made with raw, cage-free chicken with and antibiotic-free. Net Wt. 1.25 lbs. (570g). UPC 186011 001448 Manufactured by: Stella & Chewy's LLC, 2842 South 5th Court, Milwaukee, WI 53207.
Stella & Chewy's brand Stella's Super Beef Dinner Morsels for Dogs. Keep Frozen. Made with raw, grass-fed beef with no added hormones or antibiotics. Manufactured by: Stella & Chewy's LLC, 2842 South 5th Court, Milwaukee, WI 53207. Packaged in the following sizes and codes: Net Wt. 8.5 oz. (240g), UPC 186011 001554, and Net Wt. 4 lb. (1.81kg), UPC 186011 01370.
Stella & Chewy's brand Duck Duck Goose Dinner Morsels for Cats. Keep Frozen. Made with raw, cage-free poultry with no added hormones and antibiotic-free. Net Wt. 1.25 lbs. (570g). UPC 186011-001455. Manufactured by: Stella & Chewy's LLC, 2842 South 5th Court, Milwaukee, WI 53207.
Creative Snacks Co. Roasted, Salted Sunflower Seeds, 10 lb. bulk, UPC 816512013892; Plentiful Planet Roasted, Salted Sunflower Seeds, 10 lb. bulk, UPC 077420000873; Creative Snacks Co. Roasted, Salted Sunflower Seeds, 9 oz. cup, UPC 816512011218
Creative Snacks Brain Food, 3.5 oz. Snack Bag, UPC 816512015124, 10 lb. Bulk, UPC 816512013021, 9.5 oz. cup, UPC 855983002073; Fresh Market Brain Food, 25 lb. Bulk, UPC N/A, 9.5 oz. cup, UPC 737094218270,
Creative Snacks Co. Hold the Salt!, 10 lb. bulk, UPC 816512011201; Creative Snacks Co. Hold the Salt!, 8.5 oz. cup, UPC 816512011034
Creative Snacks Co. Roasted, No Salt Sunflower Seeds, 9 oz. cup, UPC 816512011294; 10 lb. bulk, UPC 816512011423; Plentiful Planet Roasted, No Salt Sunflower Seeds, 25 lb. bulk, UPC 07742417794; 10 lb. bulk, UPC 077420000880
Plentiful Planet Heart Smart Mix, 25 lb. bulk, UPC 030684710285; Publishers Clearing House Heart Smart Mix 8 oz. bag, UPC n/a; Creative Snacks Co. Heart Smart 3.5 oz. Snack Bags, UPC 816512012130; Creative Snacks Co. Heart Smart 9.5 oz. cup, UPC 855983002066; Creative Snacks Co. Heart Smart Mix 10 lb. bulk, UPC 816512013014
Creative Snacks Co. Sunny Day Splendor, 10 lb. bulk, UPC 816512014653; Creative Snacks Co. Sunny Day Splendor 10 oz. cup, UPC 816512010983
Fresh Market Healthy Snackin, 25 lb. bulk, UPC n/a
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
Salad topping labeled under the following brand names: (Product 1) Durkee Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12. UPC 047600091366. The responsible firm name on the label is ACH Food Companies, Inc. Memphis, TN; (Product 2) Hy-Vee Garden Style Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12. UPC 036800173224. The responsible firm name on the label is Hy-Vee Inc.; (Product 3) Food Club Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12. UPC 075450047554. The responsible firm name on the label is Topco Associates LLC, Skokie, IL.
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
ROAST, NO SALT SUNFLOWER SEEDS sold under the following brands: Jungle Jim 16oz (453G) INGREDIENTS: SUNFLOWER SEEDS ROASTED IN SUNFLOWER AND OR PEANUT OIL UPC 0 82987 05874 8 & Windy Acres 8 OZ (22 G) UPC 0 82987 30172 1 & 5 lb plastic bag WILMINGTON, OH 45177
Windy Acres FRUITY TRAIL MIX Roasted Peanuts, Pineapple, Papaya, Raisins & Almonds 7 OZ (198 G) UPC 0 82987 02016 5 WILMINGTON, OH 45177 1-937-382-8057
Macaroni Salad with Cheddar Cheese is packaged in a plastic bag, each case contains 2/5 lbs. bags. The label listed item #23070 and the UPC 8 87241 80712 0. The product was also sold both in Zupans Markets service deli salad case, sized to order, and available in prepacked round plastic containers (8, 12 & 16 oz.) in its Grab & Go area. Scale label on bottom of the product container reads Macaroni Salad with Cheddar Cheese with code 394.
Lance Oyster Crackers, Dist. by Snyder's-Lance, Inc., Charlotte, NC 28277
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
Raw Macadamias, 6 oz. clear plastic tubs, NET WT (170g) Whole Foods: Distributed by Whole Foods Market, Emeryville, CA: Ingredients: Macadamia Nuts; contains tree nuts. Product of Malawi: UPC: 9 99482 00132 5
Honey Bunchies Gourmet Honey Bars, 1.9 oz. snack bar containing honey, sunflower kernels, peanuts and pecans. Packaging: Box containing 20 individual bars in plastic wrappers. Manufactured by: Honey Bunchie, LLC, Longmont, CO. Individual Bar UPC 8 66192 00010 1; Box of 20 Bars UPC 8 66192 00011 8.
Meduri Farms Dried Blueberries/Sugar Infused, Catalog #s: 080282, 08028X, 08028, 080281, 08127X. Product is packaged in a BULK corrugated box with food grade plastic liner, net weight 10 lbs., 20 lbs., and 25 lbs.
Deli-Food Ancho Chile Powder 50 lb corrugated boxes x 45 each.
Michael's Naturopathic Programs Cholesterol Metabolism Factors 270 count, 180 count, and 90 count tablets packaged in plastic bottles
Cherokee Rose Hand Made cheese, Produced by Natures Harmony in Berton, GA 30635.
The Fresh Market, Smoked Supreme Nut Mix, Net Wt. 12.3 oz. (349g), Distributed by: The Fresh Market, Inc., Greensboro, NC 27408, packed in clear plastic package.
TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.
Spirit Select Bed, A-C Powered Hospital Bed
Spirit Plus Bed, A-C Powered Hospital Bed
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
Cumberland Farms Farmhouse Premium Chocolate Treats - Sea Salt Carmel Delights, 3 oz. bag
Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA
Diced and sliced yellow onions. 2.5 lb & 5 lb clear plastic bags
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Kroger DELUXE ICE CREAM S'MORES 48 FL OZ (1.5 QT) 1.4 ML INGREDIENTS: ICE CREAM***GRAHAM COOKIES***CHOCOLATE CHUNKS***CONTAINS: MILK, SOY, WHEAT, COCONUT. UPC 0 11110 01399 6 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
Tortilla Crusted Crumb is a breading system, product Item Key N21997-B. It composed of flour and other food grade ingredients. Product is bagged in 25 lbs. multiwalled polylined paper bags.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.
Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
UroDiagnost; x-ray system. Product Code: 708033
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

Product Quantity
Total for all product : 5045 cases and 12 pieces
Total for all product: 5045 cases and 12 pieces
103 50lb bags plus 3 tons bulk (5 tons bulk was used to produce recalled Kountry
US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda
9cs/12/16 oz tubs + 3 cs/12/80 bags + 6 cs/1/5lb box
42,922 units worldwide (US distribution 1,530)
1990 modules and 117 PCBAs & valves distributed in the US; 832 modules and 366 PCBAs & valves distributed outside the US

Reason for Recall
Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15. As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.
Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #11115. As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.
CHS Inc. discovered high levels of copper during routine analysis of Provider 15% Pellet both for Mature Cattle, Horses, Goats & Sheep.
CHS Inc. discovered high levels of copper during routine analysis of Kountry Buffet 14% Text for Mature Cattle, Horses, Goats & Sheep.
CHS Nutrition is recalling MSU High Alfalfa Lamb Pellets no salt B 24 due to high copper levels. The high copper levels were discovered during routine analysis of the feed.
, during routine surveillance testing by the Michigan Department of Agriculture and Rural Development.
Potential presence of Listeria Monocytogenes
Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.
Product manufactured with ingredient which may be contaminated with Listeria monocytogenes.
Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.
The firm was notified by their supplier that the Sunflower kernels they received may be contaminated with Listeria monocytogenes.
Macaroni Salad with Cheddar Cheese is recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains affected green peas that were recalled by National Frozen Foods Company.
SpartanNash Company initiated a voluntary recall of Cherry, Strawberry, and Blueberry Cheesecakes with a sell by date of 06/06/2016 to 06/21/2016, due to the potential for undeclared allergen peanut residue resulting from a supplier's recall of graham cracker crumbs.
May contain low levels of peanut residue.
Isolated episodes of leakage at the check valve were found
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
IEH sample of Whole Foods Raw Macadamia nuts had a positive result for Salmonella.
Honey Bunchie, LLC is initiating a voluntary recall of a limited number of Honey Bunchies Gourmet Honey Bars that contain SunOpta sunflower kernels that have the potential of contamination with Listeria monocytogenes.
Meduri Farms Dried Blueberries/Sugar Infused product is recalled due to a potential contamination with peanut protein. The firm found half of a peanut while packaging dried blueberries product.
Deli-Food Chili & Spice LLC announces a voluntary field action for Ancho Chile Powder due to positive testing for Salmonella.
May contain undeclared milk (in the form of calcium caseinate) and soy.
Product was found to be contaminated with Salmonella. Product was distributed to food service established only.
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.
Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury.
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
Product contains peanuts undeclared allergen
Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. The correction is via repair by a software update.
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.
The firm was notified by a customer that the whole uncut product test positive for Listeria
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Issue with design specification; oversized condition.
The firm was notified that the product was manufactured with an ingredient that may contain low levels of peanut reside which is not declared in the ingredient statement.
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Tortilla Crusted Crumb is recalled due to a potential to be contaminated with E. coli O121.
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
The manufacturing and expiration dates are not printed on the blister pack label.
In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
Amniotic Membranes were not made available for distribution in accordance with current Good Tissue Practice.
If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.

Code Info
Creative Snacks 10 lb. bulk 1296041516; Creative Snacks 8.5 oz. cup 2934041916
Creative Snacks 10 lb. bulk 1192031716; Creative Snacks 10 oz. cup 2930041916
04491050190 ONLINE TDM Vancomycin 100 tests 05108420190 ONLINE TDM Vancomycin 200 tests 04642490190 Hitachi Vancomycin (Modular P) 04642481190 Hitachi Vancomycin (917, MOD P)
(Product 1) Best by dates JUL 20 17, JUL 21 17, AUG 18 17, AUG 19 17, OCT 05 17, NOV 17 17, NOV 22 17, and FEB 09 18; (Product 2) Lot codes: 232A5 B, 238A5 B, 239A5 C, 279A5 C, 327A5 B, 327A5 C, 041A6 C, 042A6 B, and 111A6 B; and (Product 3) Best by dates JUL 21 17, OCT 05 17, NOV 17 17, and APR 20 18.
Jungle Jim Item #05874 EXP DATE: 05/2017 Windy Acres Item #30172 LOT# 051016-342 EXP DATE 03/2017 Windy Acres Item #30172B5 PACK DATES 2/19/16 - 05/12/16
All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
Model Number 9733686-02. All lot numbers manufactured by Medtronic Navigation are affected.
Model Number 9733986 . All lot numbers manufactured by Medtronic Navigation are affected.
Model Number 9730888. All lot numbers manufactured by Medtronic Navigation are affected.
Model Number 9733763. All lot numbers manufactured by Medtronic Navigation are affected.
Model Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected.
Model Number 9733467. All lot numbers manufactured by Medtronic Navigation are affected.
Model Number 9733986-02 . All lot numbers manufactured by Medtronic Navigation are affected.