US Distribution to the following states :  MA, NE and  TN  and Internationally  to Canada.
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.
Model No. 9-195-371DS, Lot/Serial Number LDS12516
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS  Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS  Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS  Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS  Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Potential for partially incomplete seal of product, impacting sterility.
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
Nationwide distribution including Puerto Rico.
AERO IOL Injection System containing 10  Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx.  The firm name on the label is Aaren Scientific Inc., Ontario, CA.  Used to fold and insert the firm's IOL's.
The recommended storage temperature on the label is incorrect.
Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
Blue Line Distribution is voluntarily recalling certain  pre-mix parbake dough mix products due to the possible presence of pieces of plastic pen, which have been found in certain batches of the pre-mix.
Deep Dish pre mix dough, Batches, Lot & Date Codes: Batch 237, 07/24/2017; Batch 689, 07/25/2017; Batch 693, 07/25/2017.
US Distribution to the states of : PA, OH and KS.
North Star Imaging Inc. (NSI)   Model X-7000 industrial cabinet x-ray system.     Industrial x-ray imaging of product hardware
It was discovered a low-level radiation leak that was  found on the NSI X-7000 system.
CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ, NY, OR, PA, SC, TX, VA, WA, WI and Canada.
Original Polenta, Melissa's brand, Shelf stable, 12/16 oz package UPC# 0-45255-11847-6    Ingredients: Water, Organic Cornmeal, Salt, Yeast Extract, Organic Granulated Onion, Organic Granulated Garlic, Organic Celery Seed, Tartaric Acid, Ascorbic Acid, Beta Carotene
Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product.  The ink is not approved for food use.
Traditional Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/18 oz packages, UPC# 7-62676-15000-6     Traditional Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 6/18oz packages, UPC# 7-62676-15000-6    Traditional Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12400-7    Traditional Polenta, San Gennaro Canadian brand, Pre-cooked Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12400-7    Traditional polenta, Sun of Italy brand, Pre-cooked Ready to Heat & Serve, 12/24oz packages, UPC# 0-33698-81697-4    Traditional Polenta, Scarpone's brand, Pre-cooked Ready to Heat & Serve, 12/1 KG packages,  UPC# 7-77465-00236-7    Traditional Polenta, Italy brand, Pre-cooked Ready to Heat & Serve, 12/24oz packages, UPC#0-71742-99951-8    Ingredients: Water, Yellow Corn Meal,  Salt, Tartaric Acid, Ascorbic Acid, Beta Carotene
Green Chili Cilantro Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18oz packages,  UPC# 6-59201-10204-6    Green Chili Cilantro Organic Polenta, Frieda's brand, Pre-cooked just heat & serve, 12/16oz packages, UPC#  0-37842-04158-8    Ingredients: Water, Organic Yellow Cornmeal, Organic Mild Green Chilis, Salt, Organic Cilantro, Organic Cumin, Tartaric Acid, Ascorbic Acid, Beta Carotene
Sundried Tomato Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18 oz packages, UPC# 6-59201-10202-2    Sundried Tomato Organic  Polenta, Frieda's brand, Pre-cooked just heat & serve, 12/16 oz packages, UPC#  0-37842-04156-4    Sundried Tomato Polenta, Zerto brand, Pre-cooked ready to heat & serve, 12/24 oz packages, UPC# 0-71270-35073-7    Sun Dried Tomato Organic Polenta, Italissima brand, Ready to heat and serve, 12/16 oz packages, UPC# 7-78518-00762-9    Ingredients: Water, Organic Yellow Corn Meal, Organic Sun-Dried Tomatoes, Organic Dehydrated Garlic, Salt, Tartaric Acid, Ascorbic Acid, Beta Carotene
Ancient Harvest=3580 cases; Frieda's=559; Zerto=123; Italissima=80
Ancient Harvest code: 070218    Frieda's codes: 011018, 030518, 053118.     Zerto code: MAY032018.    Italissima codes: 17DE25, 18MR22, 18JN20.
White Polenta, San Gennaro brand, 12/16oz packages, UPC# 7-62676-17400-2    White Polenta, San Gennaro brand, 6/16oz packages UPC# 7-62676-17400-2     Ingredients: Water, White Corn Meal, Salt, Tartaric Acid
Variety Pack Organic, Pre-cooked just heat & serve, 12/16oz packages,  UPC# 0-37842-04159-5    Includes 3 retail units each of Frieda's brand: Sun-Dried Tomato & Garlic, Basil & Garlic, Green Chili & Cilantro, Mushroom & Onion
Sun-Dried Tomato Polenta, Melissa's brand, Shelf stable, 12/16 oz package UPC# 0-45255-11848-3    Ingredients: Water, Organic Cornmeal, Organic Sun-Dried Tomatoes, Organic Tomato Powder, Salt, Yeast Extract, Organic Granulated Onion, Tartaric Acid, Ascorbic Acid, Beta Carotene
Mushroom and Onion Organic Polenta, Frieda's brand, Pre-cooked just heat & serve, 12/16oz packages, UPC#  0-37842-04155-7    Ingredients: Water, Organic Yellow Corn Meal, Organic Dried Mushrooms (may contain one or more of the following: porcini, chanterelle, shitake, portobello, oyster, maitake), Organic Dehydrated Onion, Salt, Tartaric Acid, Ascorbic Acid, Beta Carotene
Red & Black Quinoa Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18oz packages, UPC# 6-59201-10207-7    Organic red & black quinoa polenta, Anna's Country Kitchen brand, Ready to heat and serve Pre-cooked, 12/24oz packages, UPC# 6-63221-10181-1    Ingredients: Water, Organic Yellow Cornmeal, Organic Red Quinoa, Organic Black Quinoa, Salt, Tartaric Acid, Ascorbic Acid, Beta Carotene
Ancient Harvest codes: 011718, 012418, 020118, 022018.     Anna's Country Kitchen codes: 18JA24, 18MR21.
Sundried Tomato Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12401-4    Sundried Tomato Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/18 oz packages, UPC# 7-62676-15001-3    Sundried Tomato Polenta, San Gennaro Canadian brand, Ready to Heat & Serve,1 2/24 oz UPC# 7-62676-12401-4    Ingredients: Water, Yellow Corn Meal, Sun-Dried Tomatoes, Dehydrated Garlic, Salt, Tartaric Acid, Ascorbic Acid, Beta Carotene
Basil Garlic Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18 oz packages UPC# 6-59201-10203-9    Traditional Organic Polenta, Trader Joe's brand, Pre-cooked ready-to-heat and serve, 12/18oz package  UPC# 0079-7177    Basil Garlic Organic Polenta, Frieda's brand, Pre-cooked just heat & serve, 12/16 oz packages UPC#  0-37842-04157-1    Basil Garlic Organic Polenta, Italissima brand, Ready to heat and serve, 12/16 oz packages UPC# 7-78518-00761-2    Ingredients: Water, Organic Yellow Corn Meal, Organic Dehydrated Garlic, Salt, Organic Basil, Tartaric Acid, Ascorbic Acid, Beta Carotene
Ancient Harvest=9651 cases; Trader Joe's=37816; Frieda's=1254; Italissima=209
Italian Herb  Polenta, Melissa's brand, Shelf stable, 12/16 oz packages UPC# 0-45255-11892-6    Ingredients: Water, Organic Cornmeal, Salt, Yeast Extract, Organic Tomato Powder, Organic Onion, Organic Parsley, Organic Oregano, Organic Granulated Onion, Tartaric Acid, Ascorbic Acid, Beta Carotene
Traditional Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18 oz packages UPC#6-59201-10201-5    Traditional Organic Polenta, Italissima brand, Ready to heat and serve, 12/24 oz packages UPC# 7-78518-00760-5    Traditional Organic  Polenta, Frieda's brand, Pre-cooked just heat & serve ,12/16 oz packages UPC# 0-37842-04154-0    Traditional Polenta, Zerto brand,  Pre-cooked ready to heat & serve, 12/24 oz packages UPC# 0-71270-35072-0    Ingredients: Water, Organic Yellow Corn Meal,  Salt, Tartaric Acid, Ascorbic Acid, Beta Carotene
Ancient Harvest=26035 cases; Italissima=304 cases; Frieda's=1711 cases; Zerto=607 cases
Basil Garlic Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12402-1     Basil Garlic Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/18 oz packages, UPC# 7-62676-15002-0    Basil Garlic Polenta, San Gennaro Canadian brand, Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12402-1    Basil Garlic Polenta, Sun of Italy brand, Pre-cooked Ready to Heat & Serve, 12/24oz packages, UPC# 0-33698-81698-1    Ingredients: Water, Yellow Corn Meal, Dehydrated Garlic, Salt, Basil, Tartaric Acid, Ascorbic Acid, Beta Carotene
This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee.     This Rotating Hinged Knee is intended to replace patient anatomy.
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
Part Number: CP116574  Lot Number: 073840
Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO  Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
CA, CT, FL, IA, IL, MA, MD, ME, MI, NC, NH, NJ, NY, OH, PA, SC, VA, WI
Stonyfield ORGANIC O'soy Strawberry on the bottom SOY YOGURT 5.3 Oz (150g), UPC Codes: 0-52159-00603-7. KEEP REFRIGERATED
The devices were distributed to medical facilities located in MN and OH.  There was no foreign/government/military distribution.
RESONATE EL ICD VR, Model D432, Sterile.
The devices have an incorrect firmware configuration.
VIGILANT X4 CRT-D, Model G247, Sterile.      Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
RESONATE EL ICD DR, Model D433, Sterile.
Mann's Culinary Cuts Cauliettes Chopped Cauliflower, 14 oz bags;  UPC 716519069017 - US and Canada;    HEB Brand - US  14 oz. bags  UPC 4122009327    Also sold under Compliments Brand (Canada)  UPC 068820132547
CFIA sampled one salad product which resulted in a positive result for Listeria monocytogenes.
Mann's Family Favorites Cauliflower Florets,  3 lb bags;  UPC 716519020292 - US and Canada  10 oz. bag - UPC  716519014031 - US and Canada    HEB Brand  10 oz. bag  UPC - 4122032278    Walmart brand  10 oz. bag  UPC 681131091381  16 oz, bag  UPC 681131122320    Foodservice    Cross Valley Farms 3 lb. bags    Mann 3 lb. bag - pizza cut  Man 3 lb bag  UPC 716519030113    Sysco 3 lb bags (2/3lg)    also sold under Archer Farms 10 oz bag
Mann's Snacking Favorites Hummus Tray, 16.5 oz trays;  UPC -716519014758- US and Canada    Signature Farms brand Veggie & Hummus Tray, 16.5 OZ trays  UPC 021130984282
Broccoli florets;   12 oz bags;    Sold under the following brand names:    Archer Farms Brand - US:  UPC 085239319147    HEB - US  UPC - 4122097505    Little Salad Bar  UPC - 041498216030    Signature Farms - US  UPC -  021130983407    Walmart - US  12 oz UPC 681131328845  32 oz bag UPC 681131122344    Foodservice :  Mann  3 lb. bags  UPC 716519030113
Mann's Family Favorites Broccoli Carrots, 12 oz. bags  UPC 716519013058 - US    HEB brand - 12 oz. bag  UPC 4122097508
Mann's Nourish Bowls Butternut Kale Risotto, 8.75 oz tray;    UPC  716519036910- Canada
Mann's Nourish Bowls Southwest Chipotle, 10.5 oz trays;  UPC -716519036958- US;  UPC - 716519036866 - Canada
Broccoli Slaw, 12 oz bags;    Sold under the following brand names:    Western Family  UPC  -062639352295 -  Canada    Archer Farms Brand - US:  UPC 085239343142    HEB - US  UPC - 4122097512    Little Salad Bar - US   UPC -041498216047    Signature Farms - US  UPC -  021130983391    16 oz. bag  Walmart - US  UPC 681131148207    Foodservice :  Mann 4 x 3 lb. bags
HEBVeggie Toss Kit Caulibit Mushroom Sauce, 11oz bags ;  UPC  -4122017706
Archer Farms Broccoli Medley 12 oz bags, UPC 085239339145
HEB Shaved Brussels Sprouts Salad, 10OZ bags;  UPC  - 4122065112
Western Family  Kale Salad Kit, 24 oz bags  UPC  062639345938- Canada
Mann's Snacking Favorites Cheddar Pretzel Veggie Tray, 19.6 oz tray;  UPC -716519020445 - US
Mann's Nourish Bowls Bacon Maple Brussels, 7.15 oz Tray;  UPC -716519036941 - US;
Mann's Kale Beet Blend, 8 oz Bags;  UPC -716519000287- US;  UPC - 716519000270 - Canada
Mann's Vegetable Tray, 54 oz tray;  UPC -716519014055- US and Canada;  2.5 lb. tray UPC 716519014079 US and Canada    Also sold under Compliments Brand - Canada;  24 oz. trays  UPC -055742534900
HEB Power Slaw, 10 OZ bags;  UPC  -4122083223
Mann's Family Favorites Brussels Sprouts, 12 oz bags;    UPC  716519010354 - Canada; also sold under Archer Farms 12 oz bag; Manns 2 lb
Signature Farms Meat & Cheese Tray, 36 OZ trays  UPC 021130110964
Cross Valley Farms Superfood Slaw 2 lb bag
Mann's Family Favorites Vegetable Medley, 2 lb bags;  UPC -716519020155- US and Canada  Western Family Brand 2 lb bag - Canada:  UPC 062639324810    1 lb. bags -   UPC - 716519012150 - US    12 oz. bags;  UPC - 716519013041 - US and Canada    HEB Brand 12 oz. bags  UPC 4122097506      Signature Farms brand  12 oz. bag UPC 021130983322  28 oz. bag UPC 021130984466    Walmart brand  12 oz. bag UPC 681131328791  2 lb. bag UPC 681131457378
HEB Fiesta Salad, 12 OZ bags;  UPC  -4122097501
HEB Stir Fry Medley, 12 OZ bags  UPC4122097504     Walmart Stir Fry Medley, 12 OZ bags  UPC 681131457460
Mann's Nourish Bowls Bacon Maple Delight, 7.15 oz trays;    UPC  716519036934- Canada
Western Family  Kale Caesar Kit, 14.8 OZ bags  UPC  -062639352295 -  Canada
Mann's Nourish Bowl Cauli Rice Curry, 11 oz Tray;  UPC -716519036897- US    UPC - 716519036903 - Canada
Cross Valley Farms (foodservice) Spiral Cut Kohlrabi, 2 LB bags
Mann's Culinary Cuts Shaved Brussels Sprout, 9 oz. bags;  UPC  716519036859 - US and Canada; Also sold under Archer Farms 9 oz bag    Also packed in foodservice size packaging;  Cross Valley Farms - 2 lb bags  Mann 5/2 lb. bags
Mann's Family Favorites Broccoli Cauliflower Florets, 16 oz bags - UPC  716519012174- US    12 oz bags - UPC 716519013034 - US and Canada    Also sold under brand names of:  US  Archer Farms - 12 oz. bag:  UPC - 085239341148    HEB - 12 oz. bag  UPC - 4122097503    Signature Farms -   12 oz. bags  UPC - 021130983407  28 oz. bags  UPC -021130984497     Walmart - 12 oz. bag  UPC 681131328852-
Mann's Snacking Favorites Veggie Ranch Tray, 16.5 oz bags;  UPC 716519020575- US  UPC  716519020605 - Canada    Signature Farms Veggie Tray with Ranch Dip, 24 OZ. trays  UPC 021130299553  54 oz. tray  UPC 21130299560
Mann's Family Favorites California Stir Fry, 2 lb bags;  UPC 716519020186 - US;  Western Family Brand UPC 062639324858; Canada; also Signature Farms 12 oz bag  1 lb. bags, UPC  716519012181 US;  12 oz. bags UPC 716519013065 - US and Canada
Mann's Snacking Favorites Honey Turkey Cheddar, 20.3 oz Tray;  UPC - 716519020483- US
Mann's Fiesta Vegetable Tray, 35.5 oz tray;  UPC -716519088728 - US;  UPC - 716519020490 - Canada
Signature Farms Broccoli Stir Fry 28 OZ bags  UPC 021130984459
Trader Joe's  Kohlrabi Salad Blend, 10 OZ Bags  UPC 0058 6146
Mann's Family Favorites Broccoli Wokly, 1 lb. bags;   12 oz. bags. UPC '716519013010  Walmart 12 oz bag; Signature Farms 12 oz bag,
Mann's Nourish Bowl Monterey Risotto, 8.75 oz Tray;  UPC -716519036798- US;
Mann's Rainbow Salad, 12 oz bags;  UPC -716519013089- US and Canada
Mann's Broccoli Cole Slaw, 1 lb bags;  UPC  716519011009- US;  12 oz. bags;  UPC 716519013072 - US and Canada.
Western Family  Spicy Southwester Kale Kit, 22.8 OZ bags  UPC  062639352301- Canada
Mann's Nourish Bowls Sesame Sriracha, 12 oz Tray;  UPC -716519036811- US;  UPC -716519036828 - Canada
Mann  Veggie Power Blend 4/2 LB SS - US and Canada
Walmart Super Blend, 10oz bags  UPC 681131148368
Mann's Power Blend, 20 oz bags ;  UPC -716519000416- US   10 oz. bags UPC -716519013119 - US and Canada
BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960
After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level.
Worldwide Distribution - US (nationwide) Internationally to  France and Spain
FlexFlow Venous Cannula Model/Catalog Number 200-200  The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
A specific lot of the FlexFlowTM Venous  Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Product was shipped to: CO, NM, UT & WY.
BROCCOLI ALMOND SALAD Ingredients: Broccoli, Dressing, Grapes, Almonds, Raisins, Celery, Red Onion Contains: Egg, Almonds and Milk
The firm was notified that the products may be contaminated with Listeria monocytogenes.
Product purchased on 10/1/2017 thru 10/21/2017
ASIAN PASTA SALAD Ingredients: Cooked Pasta, Broccoli, Green Onion, Red Onion, Bell Peppers, Cashews, Peanuts, Carrots, Red Cabbage and Asian Salad Dressing Contains: Wheat, Cashews, Peanuts, Soy
COLORADO COLESLAW Ingredients: Salad Dressing, Cabbage, Tomatoes, Grapes, Carrots, Celery, Bell Peppers, Broccoli, Peanuts, Raisins Contains: Milk, Peanuts, Soy and Eggs
California Broccoli Salad Kit Ingredients: Salad Dressing, Cider Vinegar, Broccoli, Broccoli Slaw, Mandarin Oranges, Red Onion, Cashews, Dried Cranberries, and Bacon Contains: Milk, Egg, Cashews
Colorado, Nebraska, Northwestern New Mexico, South Dakota, Wyoming, California, Hawaii and Nevada.
Veggies w/ Dip, 8 oz.  UPC 24201200000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Recall of vegetable trays and cups after notification that they were made with product recalled by Mann Packing for potential Listeria monocytogenes.
Sell Thru Dates up to and including 10-24-17 (October 24, 2017)
Premium Vegetable Tray. 46 OZ  UPC 24210800000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Tomatoes Broccoli Cheese & Ranch Dip 530 cal. 8OZ  UPC 24288700000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Rectangular Vegetable Tray, 72 OZ  UPC 24222100000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Broccoli Carrots & Celery w/ Ranch Dip 320 cal, 9 oz..  UPC 24218900000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Round Vegetable Tray. 38 OZ  UPC 24222000000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Veggie Ranch Snack Pack. 7OZ  UPC 24191200000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Vegetables Steaming. 29 OZ  UPC 24214000000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Cauliflower,  10 oz..  UPC 24222400000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Vegetable Tray with Dip Grab n Go, 20 OZ  UPC 24282200000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Broccoli Carrots Grape Tomatoes & Dip 340 cal,10 oz..  UPC 24219000000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Vegetables Steaming, 13 oz..  UPC 24214000000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Premium Vegetable Tray, 2 lb. 14 oz..  UPC 24210800000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Cauliflower Chopped, 8 oz.  UPC 24105000000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Vegetable Tray w/Dip, 2lb 14OZ..  UPC 24250100000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Broccoli/Cauliflower,  14 oz..  UPC 24220900000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Carrots/Broccoli/Cauliflower,  14 oz..  UPC 24220800000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Broccoli Florets,  14 oz..  UPC 24221000000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Vegetable Medley W/Tomato Chipotle Butter, 12 OZ  UPC 24263200000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Broccoli Carrots Cauliflower with Ranch Dip 330 cal, 9 oz..  UPC 24218800000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
Broccoli Carrots Snap Peas & Dip 340 cal, 9 oz..  UPC 24219100000    Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups.
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Custom surgical kits labeled as follows:  (a) Suture Removal Set, 910-0002  (b) Instrument Set, INST03/20  (c) Suture Removal Set, SUT309/100  (d) Incision & Drainage Tray, INC03/20  (e) Suture Removal Set, SUT103/50  (f) General Purpose Tray, GPT010/25  (g) General Purpose Tray, GPT002/50
Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
Product was distributed throughout the United States.
Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
Labeling: Incorrect or Missing Lot and/or Exp Date;  incorrect expiration date on the labeling of the outer poly bag
Distributed domestically to MD, CO, and OH.
NucliSENS Lysis Buffer    Extended lot for RES 76675
Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples.  This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result.  If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
AL ,AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY,NC, ND,OH,OK, OR, PA, RI, SC,SD, TN, TX, UT, VA, WA, WV, WI, WY
21st CENTURY SNACK FOODS DARK CHOCOLATE ALMONDS Roasted Almonds Covered in Rich Dark Chocolate Net Wt. 6oz (170g) UPC: 0 30603 22854 9.
NY, MI, NJ, CA, OK, CO, CA, VA, LA, FL ID
Day of the Dead Truffle Cake Pops in a 10-oz. box, SKU: 162622
Cake pops may be contaminated with mold.
Market District Almonds covered in Dark Chocolate; Net Wt. 8 OZ.; Contains Soy; May Contain: Milk  Manufactured in a plant that processes wheat, peanuts, tree nuts and eggs.; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238-2809
Coffee Beans UPC: 30034 09851;  Almonds UPC: 30034 09852;   Powerberry UPC: 30034 09857
Market District Coffee Beans covered in Dark Chocolate; Net Wt. 8 OZ.; Contains Soy; May Contain: Milk  Manufactured in a plant that processes wheat, peanuts, tree nuts and eggs.; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238-2809
Market District  Powerberry Mix covered in Dark Chocolate; Net Wt. 8 OZ.; Contains Soy; May Contain: Milk  Manufactured in a plant that processes wheat, peanuts, tree nuts and eggs.; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238-2809
Recall of four varieties of Probiotic drinks due to premature spoilage. Testing has identified Candida lusitaniae as the predominate microorganism as the cause of spoilage.
Use By Dates between and including 03OCT17 thru 21NOV1
Harmless Coconut Probiotics Mangos & Acerolas;    Coconut Cultured Beverage;  UPC 859078-002719 ;  11 lf. oz. HDPE Bottle;  Keep refrigerated    Ingredients: Organic Coconut Water, Water, Organic Coconut Meat, Organic Cane Sugar, Organic Mangos, Organic Acerolsas, live and active cultures.    Harmless Harvest
Harmless Coconut Probiotics Original;    Coconut Cultured Beverage;  UPC 859078-002542;  Keep refrigerated    11 lf. oz. HDPE Bottle    Ingredients: Organic Coconut Water, Water, Organic Coconut Meat, Organic Cane Sugar, live and active cultures.    Harmless Harvest
Harmless Coconut Probiotics Strawberries;    Coconut Cultured Beverage;  UPC 859078-002566;  Keep refrigerated  11 lf. oz. HDPE Bottle    Ingredients: Organic Coconut Water, Water, Organic Coconut Meat, Organic Cane Sugar, Organic Strawberries, live and active cultures.    Harmless Harvest
Ingredients statement declared whey, powdered cheese and cheddar cheese but did not declare milk.  In addition, FD&C colors Yellow #5 and Yellow #6 are not declared.
New American Food Products, LLC DBA American Foods
Dark Chocolate Covered Ginger: CVS Gold Emblem Dark Chocolate Covered Ginger 9oz (255g), UPC: 050428540220;Ocean State Candy Break Dark Chocolate Ginger 9oz (255g), UPC:024354501006
Dark Chocolate Espresso Beans: CVS Gold Emblem DARK CHOCOLATE ESPRESSO BEANS 2.25oz (64g) UPC: 0504428576601; CVS Gold Emblem Dark Chocolate Espresso Bean 5oz (142g), UPC: 050428513583; Candy Break Dark Chocolate Espresso Beans 2.75oz (78g), UPC:024354650049; Hannaford Excellent Espresso Beans 2.75oz (78g), UPC: 041268206414; Market Basket Dark Chocolate Espresso Bean 3oz (85g), UPC: 049705168240; Weigels Dark Chocolate Espresso Beans 2.75oz (78g), UPC: 024354705206
Dark Chocolate Covered Almonds: Market Basket Dark Chocolate Almonds 11oz (311g), UPC: 049705169650
Dark Chocolate Covered Berries: CVS Gold Emblem Dark Chocolate Berries 8oz (227 g), UPC: 0 50428 54100 5; Ocean State Candy Break Dark Chocolate Powerberries 9oz (255g), UPC: 024354501105
Source Plasma units, not meeting product specifications, were distributed.
Source Plasma unit, not meeting product specifications, was distributed.
Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and  Tunisia.
Xper Flex Cardio PhysioMonitoring system   The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.
Intermittent communication between the host system and the Flex Cardio
Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
Apheresis product, in which platelet yield did not meet specifications, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis product, in which residual WBC count was not performed, was distributed.
Transplant Services Center UT Southwestern Medical Center
Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Blood and Blood Products for Reprocessing
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
W047017157786 (triple collection); W047017306460 (triple collection); W047017388090 (triple collection)
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products, in which donor suitability was not adequately determined, were distributed.