Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally  to Canada.
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case;   For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
product code 2N3345, lot number UR12E03108
Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally  to India, Australia, Canada, England, Qatar, and Scotland.
Centricity Laboratory Core Lab System 4.1    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.
The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the  corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.
IFS Web Bulk Pistachio Raw Shelled 80% Wholes Net Wt. 30 lb. (13 kg)  International Foodsource LLC 52 Richboynton Rd. Dover NJ 07801 UPC 790429239630
Raw pistachios may be contaminated with Salmonella which was determined through FDA contract laboratory testing.
IFS Club Bag Pistachio Raw Shelled 80% Wholes Net Wt. 3 lb. (1 kg)  International Foodsource LLC 52 Richboynton Rd. Dover NJ 07801 UPC 790429243026
Valued Natural Raw Pistachio Kernels Net Wt 5 oz. (141 g)  International Foodsource LLC 52 Richboynton, Rd. Dover, NJ 07801 UPC 790429241428
Sam International Bulk Raw Whole Pistachio 80% VP  Net Wt. 30 lb  Packaged in Boxes
Product was distributed to IA, IL, MO, KS, NE, SD, MN, and WI.  There was no foreign/government/military distribution.
Whole wheels and cuts of Maytag blue cheese re-packaged in foil or clear plastic wrap with scale labels in various weights.  Product was labeled as Maytag Blue Raw Milk, Maytag Blue, or Maytag Iowa Blue Cheese with PLU numbers beginning with 854089001.
Product may be contaminated with Listeria monocytogenes.
Use by dates:  Jan. 20, 2016 through May 3, 2016.
Maytag Blue cheese crumbles re-packaged and sold in plastic containers with scale labels in various weights.  Product was labeled as Maytag Blue Raw Milk, Maytag Blue, or Maytag Iowa Blue Cheese with PLU numbers beginning with 854089001.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.
Beneful Chopped Blends Beef canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-15494.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Product may contain less vitamins and minerals than label purports.
5363 to 6054; Best Buy Jun 2017 to Aug 2017
Beneful Prepared Meals 12-count variety pack containing wet dog food packaged in 10 oz. plastic tubs:  4 tubs savory rice and lamb stew, 4 tubs chicken stew, and 4 tubs beef stew with UPC 17800 - 16814.  Product is shipped in cases of 12 packs.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Beef Stew canned wet dog food packaged in 10 oz. plastic tubs with Canada UPC 55800 11651.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Simmered Beef canned wet dog food packaged in 10 oz. plastic tubs with Canada UPC 55800 11649.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Beef and Chicken Recipe canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-12859.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Roasted Turkey Medley canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10968 and Canada UPC 55800-11562.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Pro Plan Savory Meals braised chicken canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16148.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Chopped Blends Lamb canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-15498 and Canada UPC 55800-21238.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Savory Rice and Lamb Stew canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10967 and Canada UPC 55800 10556.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Chopped Blends 6-count variety pack containing wet dog food packaged in 10 oz. plastic tubs:  2 tubs lamb, 2 tubs chicken, and 2 tubs beef  with UPC 17800 - 16627.  Product is shipped in cases of 6 packs.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Pro Plan Savory Meals braised turkey canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16147.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Pro Plan Savory Meals braised pork canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16151.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Pro Plan Savory Meals grilled salmon canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16155.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Simmered Chicken Medley canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10964 and Canada UPC 55800-10549.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Chicken Stew canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-12861 and Canada UPC 55800-11564.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals 6-count variety pack containing wet dog food packaged in 10 oz. plastic tubs:  2 tubs savory rice and lamb stew, 2 tubs chicken stew, and 2 tubs beef stew with UPC 17800 - 15030.  Product is shipped in cases of 6 packs.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Chopped Blends Turkey canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-16966.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Roasted Chicken Recipe canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10764 and Canada UPC 55800 10554.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Chopped Blends Salmon canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-16962.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Pro Plan Savory Meals braised beef canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16143.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Simmered Beef Entree' canned wet dog food packaged in 10 oz. plastic tubs with UPC 17800-10963.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Prepared Meals Beef Stew canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10965.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Chopped Blends Chicken and Liver canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-16960.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Beneful Chopped Blends Chicken canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-15496 and Canada UPC 55800-21254.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.
Phibro Animal Health Corporation  NeoTerramycin 100/100D Type A Medicated Article  Net Weight 50 lb (22.7 kg)  Distributed by Phibro Animal Health Corporation Teaneck NJ 07666  NDC 66104-8851-0    Packed in a 50 lb bag (22.6 kg/bag); Multi-wall bag with the following construction/configuration; 4 ply Natural Kraft and 1 ply 2.0 mil HDPE
This recall was initiated because NeoTerramycin (100/100D lot number A41770017NK tested below (88.5 g/lb) the potency specification of 89.5-115.4 g/lb at the 18 month stability interval under VICH long-term conditions.
Lot number A41770017NK Expiration Date 03/31/2016 (March 31, 2016).
CA: distributed in San Diego, Riverside, and San Bernardino counties
American Gourmet is recalling American Gourmet Roasted and Salted Pistachios because they may be contaminated with Salmonella.
U.S. distribution to the following; CA, LA, AZ, NV, NY    Foreign distribution to the following; China, Indonesia, Hong Kong, Srilanka
Wonder Meal  Net Weight 455 grams 15.75 oz  UPC Code: 6 03808 12813
Undeclared milk from the listed ingredient of whey protein.
The Republic of Tea - Organic Turmeric Ginger: Green Tea  Ingredients: Organic Turmeric, Organic Green Tea, Organic Ginger, Organic Cinnamon and Natural Honey Flavor    Packed in 250 CT Bulk Bag (375 g) and  and  50 count refill bag. (75 g)    UPC - 250 bulk bag: 7-42676-30655-9   UPC 50 CT refill: 7-42676-42155-9 .    The Republic of Tea
Republic of Tea was notified by their supplier of a positive result for Salmonella in organic ginger that they  received and distributed.
Best Sipped by March 23, 2018  and April 13, 2018
Organic Turmeric Ginger Spice of Life Green Tea;  Organic Blend of Tumeric, Spices, Natural Honey Flavor and Fine China Green Tea  50 CT Tin: Net Wt. 2.65 oz.. (75G)  UPC: 7-42676-40355-5.    The Republic of Tea
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
A diode was inadvertently not assembled  into the system, which may result in coil overheating
Domestic Only: IL, MI, WI    No Foreign or VA/DOD
Nappa Shredded 2/5 lb, packaged in plastic, keep refrigerated
Pearson Foods Corporation is voluntarily recalling a limited number of packaged Kale products because they may be contaminated with Salmonella.
Nappa Shredded (3/8 inch)  2/5 lb, packaged in plastic, keep refrigerated; Manufactured on 04/26/16, Use by Date of 5/6/16 and 5/7/16 Tracking Code 643
Kale, 4/ 1 lb, & 1 /2 lb shredded packaged in plastic, keep refrigerated
Kale, 4/1 lb shredded packaged in plastic, Use by date May 8th, 2016; manufactured on 04/26/2016; and RC Kale (3/8 inch) 1/2 lb shredded,  Manufactured on 04/26/16, Use by of 05/07/16, tracking code 643
Carfagnas Spicy Chili Ready Sauce in 32 oz. glass jars.
Acidified process not on file with the FDA
Distributed to the US, to the states of NH, OK, AL, PA, IL, MA, TX, MI, NC, CA, MN, CT, GA, NY, WI, KY, OH, VA, AL, NJ, TN, SD, and IN.
Double Pump RF Patient Cassette; Product Number: 72204055.    Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
Sterility of device may be compromised due to sterile package breakage.
PRESIDENT brand Authentic Pub Cheese SPREADABLE CHEESE, Cheddar & Porter Ale, Net Wt. 8 oz. (226g), UPC 070153229047 --- Dist. by Lactalis American Group, Inc. Buffalo, NY 14220 --- The product is manufactured approximately every 5 weeks (from 11/02/2015 to 04/06/2016).
The product contains undeclared wheat from ingredient used in production.
Recalled product was distributed to Kansas, Missouri, Texas, Oklahoma, Arizona, Wisconsin, and Illinois.  There was no government or military distribution.
Cream Cheese Base packaged in ?.  UPC code is 680816002711. Packaged in 18 pie bases per case.  Shipped frozen.
Product was manufactured with an ingredient which has the potential to contain low levels of peanut residue.
Keylime Base packaged in ?.  UPC code is 680816000205. Packaged in 18 pie bases per case.  Shipped frozen. Net wt. 31oz each.
Key Lime Base packaged in ?.  UPC code is 680816001851. Packaged in 12 pie bases per case.  Shipped frozen. Net wt. 21oz each.
Tippins Mini Key Lime Base packaged in ?.  UPC code is 680816000106. Packaged in 30 pie bases per case.  Shipped frozen. Net wt. 11oz each.
Key Lime Pie packaged in aluminum pie plates with plastic covers.  The responsible firm listed on the label is TGP, LLC Kansas City, KS 66106.  UPC code is 680816050057. Packaged in 8 pies per case.  Shipped frozen.
Product with was manufactured with an ingredient which has the potential to contain low levels of peanut residue.
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY)    The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
ACD-A, Anticoagulant Citrate Dextrose Solution, Solution A, USP, 30 mL.   Packaged under the following labels:  P/N: 9332 labeled for Biomet  P/N: 9335 labeled for Cytomedix  P/N: 9338 la bled for SpineSmith   P/N: 9350 Citra label
Citra Lab's ACD-A and tri-Citrasol anticoagulants, both manufactured in glass containers which may contain a defect and compromise sterility of the products, were distributed.
Citra Labs triCitrasol, Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, 30 mL  P/N 6030-10 bottles/case  P/N 6032-12 bottles/case
PN6030 Lot Numbers:  G32E  G32K  15C02A  15C02B    PN6032; Lot Number G32H
Sanwa International Wholesale Foods, LLC
Organic Hot Finger Peppers (Florida), sold  in 0.5-1 lb plastic bags.  Each case will hold approximately 15-20 bags.
300 pounds total, approximately 15-20 cases.
The cases in the lot were distributed to retailers in Connecticut, Illinois, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, West Virginia.
Euro Custard Cake, Plastic wrapped cardboard container (Net Wt. 7.20 oz.)
The New York Department of Agriculture and Markets tested the Euro Custard Cake an detected that the product contained milk.  The label did not declare milk and list it as an allergen on the label. Eastland Food Corporation became aware of these results on June 21 when FDA visited it facility.   Eastland Food Corporation performed an investigation into the matter and determine late on June 22 that a single lot (310 cases) of product was missing this information.     To this point no adverse incidents have been reported due to the mislabeling.  Health risk assessment, people who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected Euro Custard Cakes under the mistaken assumption that it does not contain milk.
US: All states in USA including PUERTO RICO, VIRGIN ISLANDS  except AK, SD & WV.    OUS: ARUBA, BARBADOS, TRINIDAD & TOBAGO, CURACAO, BERMUDA,  CHILE JAMAICA, SINGAPORE, FRENCH POLYNESIA, HONG KONG.
Nature Valley Protein Chewy Bars,  Peanut, Almond, & Dark Chocolate,   Carton UPC  000-16000-45724,  Case UPC 100-16000-45724, 5 bars/carton,   , 5-1.42 OZ (40g)BARS, NET WT 7.1 OZ (201g).
762,319 cases and 1544 pallets for all products.
General Mills announced  a voluntary U.S. recall of multiple skus of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars.  The recall is being issued in association with the expanded recall of sunflower kernels from SunOpta due to the potential presence of Listeria monocytogenes.
All date codes within shelf life.    BIUB 29MAR2016HN through BIUB 18JAN2017HN
Nature Valley Protein Chewy Bars, Honey, Peanut & Almond with Pumpkin Seeds, Carton UPC 000-16000-47196, Case UPC 100-16000-47196, 5 bars/carton, 5-1.42 OZ (40 g)BARS, NET WT 7.1 OZ (201 g).
All date codes within shelf life.  BIUB 29MAR2016HN through BIUB 18JAN2017HN
Nature Valley Simple Nut Bars,  Almond, Cashew & Sea Salt,  Carton UPC 000-16000-46474, Case UPC 100-16000-46474, 	4 bars/carton, 4 1.17 OZ (33 g) BARS, NET WT 4.68 OZ (132 g).      Nature Valley Simple Nut Bars,  Almond, Cashew & Sea Salt, Carton UPC 000-16000-41301, Case UPC 000-16000-47734,	25 bars/carton.
All date codes within shelf life.  BIUB 24MAR2016JA through BIUB 17DEC2016JA.
Nature Valley Simple Nut Bars , Roasted Peanut & Honey, Carton UPC 000-16000-46475, Case UPC 100-16000-46475, 4 - 1.17 OZ (33 g) BARS,  NET WT 4.68 OZ (132 g), 4 bars/carton.      Nature Valley Simple Nut Bars,  Roasted Peanut & Honey.   Carton UPC 000-16000-41308, Case UPC 100-16000-41308,  16 bars/carton, 16 -1.17 OZ (33 g) BARS, NET WT 1 LB 2.72 OZ (18.72 OZ) 530 g.
Product was distributed to 25 retail stores domestically and 1 medical facility. The product was also distributed to Ioannina, Greece and Garthabae, Iceland.
. The package is a white 5 oz box with grey and purple lettering.
NOW Product #: 8024  NOW Lot#: 1958257  NOW Batch #: 575948  Contract Mfg. Lot#: 25483
Philips Electronics North  America Corporation
Allura Xper with release R8.2: Allura Xper FD10,  722026; Allura Xper FD10/10,  722027; Allura Xper FD20,  722028; Allura Xper FD20/10 biplane,  722029;  Allura Xper FD10 OR Table,  722033; Allura Xper FD10/10 OR Table,  722034;  Allura Xper FD20 OR Table,  722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table,  722039; Allura Xper FD20/15,  722058; Allura Xper FD20/15 OR Table,  722059
1536 devices (includes both Allura and UNIQ)
Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
USA:  CA, CO, CT, FL, IN, IA, MD, NH, NY, TX, WA, WI.
Case: Beyond Meat Vegetarian Indian Curry with Beyond Chicken, GMI Item # 46671000, Frozen. Net WT 5 lbs (2.2 KG) 8 - 10 oz (263 g).     Individual items: 21 Grams of Plant Protein, Vegetarian Indian Curry with Beyond Chicken, Net WT 10 oz (263 g), UPC is 000-16000-46671 , Keep Frozen.
General Mills today announced a voluntary recall of a limited quantity of frozen Beyond Meat Vegetarian Indian Curry with Beyond Chicken.   The recall is being issued as a precaution after the producer of frozen peas used as an ingredient in this product issued a national recall for the potential presence of Listeria monocytogenes.
Nationwide Distribution to Illinois, Florida and Georgia.
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico)  The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Through an error, the labeling failed to include the symbol or other text indicating that the  diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only.    This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.
Waiting for clarification from the firm.
Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)  The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150).   The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
American National Red Cross (The) - North Central Region
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood products, with incomplete documentation of the irradiation process, were distributed.
US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
Philips DuraDiagnost stationary X-ray system
, in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Worldwide Distribution - US (nationwide) and Canada.
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the missing locking clasp component.
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)
Blood products, collected from an ineligible donor, were distributed.
Blood and Blood Products for Reprocessing
Mindray DS USA, Inc. dba Mindray North America
US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada
A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.  Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
167 units (165 units - US) and (2 units - International)
Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.
distributed in CA, MI, TX.  The firm also sold product online nationwide from the company's website http://www.jdfoods.net/
Original Bacon Flavored Seasoning Salt, Big Pig brand, 16oz plastic jars, 3 jars per case.  UPC 98300 00110
Original Bacon Flavored Seasoning Salt, Big Pig brand, is recalled due to a potential to be contaminated with E. coli O121.
Aurora Area Blood Bank Dba Heartland Blood Centers
Primo Fresh Serrano Peppers Distributed by Warren Produce, 824 W. Monte Cristo Rd, Edinburg, TX packaged in 1/4 bushel waxed cardboard boxes, 1 1/9 bushel waxed cardboard boxes, 10 lb waxed cardboard boxes, 5 lb waxed cardboard boxes and 35 lb RPC crates.
US Distribution to the states of : FL, KS, and WV.
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Cracking may occur at the 15mm and 22mm ISO female  connector.
Product was distributed to one customer in Holden, MO.
This is a custom horse feed, packaged in 50 pound bags, Net Weight 50 Lb (22.6 kg).  Most responsible firm listed on the label is West Central AgriServices Chilhowee, Missouri 64733.
Product is misbranded and contains monensin and sulfamethazine which caused two horse deaths.
Worldwide Distribution - US (nationwide) Internationally  to  Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
CURVED-TIP STAPLER 30,IS4000; Model number 470530;    General and Plastic Surgery:  The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult  and pediatric use. The device can be used with staple line or tissue buttressing material.
875 instruments (827 a la carte + 48 in kits); total, all models
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30  instruments having an interruption in shaft rotation and / or instrument jaws not opening.
STAPLER 30,IS4000; Model number 470430;    General and Plastic Surgery:  The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult  and pediatric use. The device can be used with staple line or tissue buttressing material.
875 instruments (827 a la carte + 48 in kits) total, all models
STAPLER,IS4000; Model number 470298;    General and Plastic Surgery:  The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
SODIUM BICARBONATE, CAS # 144-55-8, USP/FCC GRADE 1, NET WEIGHT 50 lbs./22.68 kg --- Natrium Products, Inc. 58 Pendleton Street, Cortland, NY 13045
Sodium Bicarbonate bulk lot 08315A may contain varying amounts of lubricating oil (food grade oil designated NSF 11).
Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***
Alcon AcrySof IQ IOL with ULTRASERT Delivery System    Product Usage:  The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.
The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
SMR allen wrench 5 mm, product code 9013.50.210
Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.
Worldwide Distribution - US to MA, NY, MI, IL, TX, CO, AZ, CA, WA and Foreign distribution to the following countries: Australia, Austria, Bahrain, Brazil, China, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Portugal, Portugal, Republic Korea, Singapore, Slovakia, Spain, Sweden, Turkey, United Kingdom, and Vietnam.
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR).   The ADVIA Chemistry XPT System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour
Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123).  This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR).  The ratio equation used to calculate ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results in IFCC units contains an error.  The error results in falsely depressed HbA1cR results.
JUST Chocolate Chunk Muffin Mix;  NET WT 20.8 oz. (1 lb 4.8 oz) 590 g);  UPC 8 54829 00656 5.    Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine monomonitrate, riboflavin, folic acid), Sugar, Palm Oil, Baking Powder (sodium acid pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate.   Contains less than 2% of Baking Soda,  Coconut Milk Powder )coconut milk, tapioca syrup), Dextrose, Lactic Acid, Natural Flavors, Oat Bran, Oat Hull Fiber, Seasoning (Potassium Chloride, Wheat Flour) , Salt, Sodium Aliginate, Sorghum Flour, Soy Lecithin (emulsifier), X.anthan Gum.  Chocolate Pack: Bittersweet chocolate chunks (unsweetened alkalized chocolate, sugar, cocoa butter, soy lecithin (emulsifier)..    Contains: Wheat, Soy, Coconut.  Bake at 400 degrees for 16-19 minutes.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.
Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.
JUST Cinnamon Roll Coffee Cake Mix;  NET WT 26.9 oz. (1 lb 10.9 oz) 762 g);  UPC 8 54829 00644 2.    Ingredients: Cake Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine monomonitrate, riboflavin, folic acid), Sugar. Contains less than 2% of Baking Powder (sodium acid Pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate), Baking Soda, Citric acid, Natural Flavors, Oat Bran, Oat Hull Fiber, Palm Oil, Salt, Sodium Aliginate, Sorghum Flour, Soy Milk Powder, X.an than Gum.  Icing Mix: Powdered Sugar (dried cane syrup, corn starch), Canola Oil, Soy Milk Powder, Corn Starch, Modified Food Starch, Salt, Natural Flavors, Citric Acid.  Swirl Mix: Brown Sugar, Sugar, Canola Oil, Invert Sugar, Cinnamon, Salt, Natural Flavors, Spice, Citric Acid.  Yeast Pack: Yeast (yeast, Sorbitan monostearate, ascorbic acid.    Contains: Wheat, Soy, Coconut.  Bake at 350 degrees for 30-44 minutes depending on pan size.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.
Sell by Date: 05/28/2017;  Lot code: 11616C
JUST Blueberry Muffin Mix;  NET WT 23.3 oz. (1 lb 7.3 oz) 660 g);  UPC 8 54829 00685 5.    Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine Monocitrate, riboflavin, folic acid), Sugar, Palm Oil., Baking Powder Sodium acid pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate.  Contains less than 2% of Baking Soda,  Coconut Milk Powder (coconut milk, tapioca syrup), Dextrose, Lactic Acid, Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy lecithin (emulsifier), Xanthan Gum.    Blueberry Mix: Blueberries, Water:  Crumble Mix: Sugar, Brown Sugar, Maltodextrin, Palm Oil, Enriched flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine monocitrate, riboflavin, folic acid), cinnamon, Salt, Natural Flavors:    Contains: Wheat, Soy, Coconut.  Bake at 350 degrees for 16-19 minutes.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.
JUST Yellow Cake Mix;  NET WT 20 z. (1 lb 4oz) 567 g);  UPC 8 54829 00642 8.    Ingredients: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine monomonitrate, riboflavin, folic acid), Sugar, Palm Oil. Contains less than 2% of Baking Powder (sodium acid Pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate), Baking Soda, Citric acid, Coconut Milk Powder (coconut milk, tapioca syrup), Fruit and Vegetable Juice (color) Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy Milk Powder, X.anthan Gum.    Contains: Wheat, Soy, Coconut.  Bake at 350 degrees for 24-16 minutes depending on pan size.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.
JUST White Cake Mix;  NET WT 20 oz. (1 lb 4 oz) 567 g);  UPC 8 54829 00688 6.    Ingredients: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), Sugar Palm Oil, Contains less than 2% of Baking Powder (sodium acid Pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate), Baking Soda, Citric acid, Coconut Milk Powder (coconut milk, tapioca  syrup), }, Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy Milk Powder, X.an than Gum.    Contains: Wheat, Soy, Coconut.  Bake 350 degrees 24-26 minutes depending on pan size.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.
JUST Devil's Food Cake Mix;   NET WT 20 oz. (1 lb 4 oz) 567 g);   UPC 8 54829 00643 5.     Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, niacin, reduced Iron, thiamine Monocitrate, riboflavin, folic acid), Sugar, Palm Oil., Alkalized Cocoa. . Contains less than 2% of Baking Powder )Sodium acid pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate) Baking Soda, Citric Acid, Coconut Milk Powder (coconut milk, tapioca syrup), Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy milk powder, Xanthan Gum.     Blueberry Mix: Blueberries, Water: Crumble Mix: Sugar, Brown Sugar, Maltodextrin, Palm Oil, Enriched flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine monocitrate, riboflavin, folic acid), cinnamon, Salt, Natural Flavors:     Contains: Wheat, Soy, Coconut. Bake at 350 degrees for 24-34 minutes depending on pan size. Distributed by Hampton Creek, Inc., San Francisco, CA 94103.
Minnie Marie Bakers, Inc. dba Awrey's Bakery
Devils Food Sheet Cake 8x12 Mega   28.125 lb case 20, 2  2.5oz cakes per case
Products may contain undeclared tree nuts (walnuts).  People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
White Sponge Cake 8x12  30 lb case  20, 24oz cakes per case
Deep Chocolate Sheet Cake 8x12   28.125 lb case 20,   22.5 oz cakes per case
Chocolate Roll Cake 15x24   22 lb case 8,   2 lb 12 oz cakes per case
Nationwide  Foreign: Canada, Latin America
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing  as follows:      This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit.        US Product Codes:  72021                      72358                      71180-01                   76021                      76022                      76023                      76024                      76025                      71801-01                   71801-01                   71801-01                   71801-01                   71801-01                   74163-03                   71296-01                   74460-01                   74460-01                   74460-01                   73208-03                   74382-01                   74382-01                   74382-01                   74916                      74916                      74916                      70089-07                   74063-01                   74063-01                   74460-01                   74460-01                   74460-01                   74460-01                   75252-01                   74951                      75881                      74271-01                   71085-02                   72742                      75314                      75368                      75368                      76095                      76095                      73339-01                   73789                      74417                      72204                      72965-03                   73644                      73645-01                   73700
Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated
US Lot Codes:  UG06                            UE18R                           UF31                            UF31A                           UF31T                                        UG13                            UG13A                           UG20                            UG20T                           UG27                            UG27T      OUS Lot Codes:                     UG13                            UG13T                           UG20                            UG20T
Integra LifeSciences Corp. d.b.a. Integra Pain Management
US Distribution to the states of : OH and CA.  No foreign, Govt/VA/military consignee.
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the  Spinal Trays.
U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.
Chicken Patty Sandwich on a Whole Grain Bun  Product ID 400003
All American Cheeseburger  Product ID 470007
Chicken Double Dogs on Whole Grain Bun  Product ID 809021
BBQ Rib Sandwich  Product ID C46007, 460007
Cheeseburger Sliders  Product ID C47220, 470220
Chili Dog, Low Fat/Low Sodium  Product ID 952000
Beef Sausage Breakfast Sandwich  Product ID C99018
Beef Sausage & Cheese Mini Bagel Sandwich  Product ID C80916
All American Burger  Product ID 470007, C47007
Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam.
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222  UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU)   Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.
US Distribution to states of:  TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09.    Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured  images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed  and approved by the FDA.
Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle.
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,  ND, NH, NJ, NM, NV,  NY, OH, OR, PA, TX, VT, WA, WI, WV,  and WY; and, the countries of Canada, Brazil, Germany, Iraq, Japan, Korea, Kuwait, Libya, Mexico, Portugal, and Qatar.
PCR Compano Basic Reader using 100-127V as mains voltage.  Model numbers: 732027, 732028, and 732040.      Radiological image processing system (Computed Radiography).
A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
RadSuite software.  The firm name on the label is Merge Healthcare, Hartland, WI.    RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
96 sites potentially have the affected versions for both products
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI.     iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO,  Custom surgical kit.
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap.  The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Nambia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.
Monaco RTP System    Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.
Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
HexaPOD evo RT System    Product Usage:  The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected form a donor who previously tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, was distributed.
WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada, Malaysia, Poland, Singapore, Lithuania, Romania
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set.  The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.
WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the NIO-P models  have the same activation mechanism. However, none of the affected lots of the NIO-A are distributed in the US, and thus the company is only recalling a single lot of NIO-P in the US.
Misbranded apheresis products were distributed.
Blood Centers of the Pacific - Irwin Center
Blood product, not meeting product specifications, was distributed.
Lifesouth Community Blood Centers - Montgomery Region
Plateletpheresis product, for which the quality control testing for pH did not meet specifications, was distributed.
Merge Cardio software.  The firm name on the label is Merge Healthcare, Hartland, WI.
116 customers potentially have the affected versions
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).