The Recall Desk

Archive

April 2017 recalls

850 recalls were announced in April 2017.

What the numbers show

Critical
99
Severe
150
High
458
Moderate
121
Low
22

Of the 850 recalls this month scored against our rubric, 12% are Critical, 18% are Severe.

401–500 of 850

  • SevereNHTSA·17E021000·2017-04-18

    Cummins Recalls ISV5.0 Diesel Engines in Tiffin Breeze Motorhomes

    Cummins is recalling ISV5.0 diesel engines in Tiffin Breeze motorhomes because a fan support bearing may fail, causing the engine to stall and increasing crash risk.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:DIESEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V258000·2017-04-18

    Volvo Recalls 2015-2017 VHD Trucks for Incorrect Axle Weight Labels

    Volvo is recalling 2015-2017 VHD trucks because the Gross Axle Weight Rating on the certification label may be incorrect, which could lead to vehicle overloading.

    Product
    VOLVO — VOLVO VHD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V256000·2017-04-18

    Honda Recalls 2017 CR-V and Acura RDX for Fading Certification Labels

    Honda is recalling 2017 CR-V and Acura RDX vehicles because certification labels may wipe away with alcohol solvents, potentially leading to vehicle overload.

    Product
    ACURA — ACURA, HONDA RDX, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V253000·2017-04-13

    Nissan Recalls Sentra and Leaf Vehicles for Air Bag Defect

    Nissan is recalling 2014-2017 Sentra and 2015-2017 Leaf vehicles because the front passenger air bag may not deploy properly in a crash.

    Product
    NISSAN — NISSAN SENTRA, LEAF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E020000·2017-04-13

    FiveCubits Recalls TREQ-VMx Tablets Due to Battery Overheating Risk

    FiveCubits is recalling TREQ-VMx mobile data tablets used by commercial truck operators because the lithium ion polymer batteries may overheat, increasing the risk of fire.

    Product
    ELECTRICAL SYSTEM:SOFTWARE recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17740·2017-04-13

    Polaris Recalls Sportsman ATVs Due to Electronic Power Steering Malfunction

    Polaris is recalling about 3,800 model year 2017 Sportsman and Scrambler ATVs because the electronic power steering unit can malfunction, posing a crash hazard.

    Product
    Sportsman 450, 570, 850, 1000 and Scrambler 1000 all-terrain vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17132·2017-04-13

    Polaris Recalls Ranger 900 Vehicles Due to Fire and Burn Hazards

    Polaris is recalling about 51,000 Ranger 900 recreational off-highway vehicles because a heat shield can fall off, posing fire and burn hazards.

    Product
    Polaris Ranger 900 recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17131·2017-04-13

    Bosch Recalls Roof-Mounted Solar Panels Due To Fire Hazard

    Bosch Solar Services is recalling about 28,000 roof-mounted solar panels because they can overheat and pose a fire risk. No injuries have been reported.

    Product
    Roof-mounted Bosch solar panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0640-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling specific lots of Vancomycin HCl IV bags due to the presence of particulate matter, following a related Hospira recall.

    Product
    Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1831-2017·2017-04-12

    Lipari Foods Recalls Premo Sandwiches Due to Listeria Risk

    Lipari Foods is recalling Premo Signature Classic Italian sandwiches because a supplier recalled cheese contaminated with Listeria monocytogenes.

    Product
    Premo Signature Classic Italian, 1/6 oz.
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1827-2017·2017-04-12

    Lipari Foods Recalls Ready-to-Eat Turkey Sandwiches Due to Listeria

    Lipari Foods is recalling specific ready-to-eat turkey sandwiches because a supplier recalled cheese containing Listeria monocytogenes.

    Product
    Premo Turkey & Garlic Mayo Item # 207455, Net wt. 5.5 oz; Core-Mark Turkey & Garlic Mayo Item # 568207, Net wt. 5.5 oz; Fresh Grab Turkey & Provolone with Garlic Mayo Item # 455956, Net wt. 5.5 oz
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1858-2017·2017-04-12

    Vulto Creamery artisanal cheese recalled for Listeria monocytogenes contamination

    Vulto Creamery is recalling 211 wheels of handmade cheese due to Listeria monocytogenes contamination. The product was distributed nationwide, primarily in the Northeast, Mid-Atlantic, California, and Chicago.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, Hamden, NET WT. 3.5 lbs
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1853-2017·2017-04-12

    Vulto Creamery Recalls Handmade Miranda Cheese Due to Listeria Risk

    Vulto Creamery is recalling handmade Miranda cheese nationwide due to Listeria monocytogenes contamination. Consumers should discard or return the product.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, Miranda, NET WT. 0.5 lbs,
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1848-2017·2017-04-12

    Biery Cheese Recalls Marketside Swiss Cheese for Listeria

    Biery Cheese, Inc. is recalling Marketside Grab and Go Swiss cheese because the supplier reported the product tested positive for Listeria monocytogenes.

    Product
    Marketside Grab and Go Swiss 10.8 oz Set Ups
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1846-2017·2017-04-12

    Biery Cheese Recalls Marketside Colby Cheese Due to Listeria Risk

    Biery Cheese, Inc. is recalling Marketside Grab and Go Col Colby cheese because the supplier reported positive Listeria monocytogenes tests.

    Product
    Marketside Grab and Go Col Colby 10.8 oz Set Ups
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-0637-2017·2017-04-12

    X-Gen Recalls Ibuprofen Lysine Injection Due to Particulate Matter

    X-Gen Pharmaceuticals is recalling 2,593 cartons of Ibuprofen Lysine Injection because of the presence of particulate matter. The affected product was distributed nationwide in the USA.

    Product
    IBUPROFEN LYSINE — IBUPROFEN LYSINE (IBUPROFEN LYSINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1852-2017·2017-04-12

    Vulto Creamery Handmade Cheese Recalled for Listeria Contamination

    Vulto Creamery is recalling 426 wheels of handmade cheese due to Listeria monocytogenes contamination. The product was distributed nationwide, with most sales in the Northeast, Mid-Atlantic, California, Chicago, Portland, and Washington, DC.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, Ouleout, NET WT. 2 lbs
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1859-2017·2017-04-12

    Vulto Creamery Recalls Artisanal Cheese Due to Listeria Contamination

    Vulto Creamery is recalling 484 wheels of Walton Umber artisanal cheese because of Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, Walton Umber, NET WT. 4 lbs
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1828-2017·2017-04-12

    Lipari Foods Recalls Ham and Provolone Sandwiches Due to Listeria

    Lipari Foods is recalling specific Ham & Provolone sandwiches because a supplier recalled cheese contaminated with Listeria monocytogenes.

    Product
    Premo Ham & Provolone Item # 207851, Net Wt 6 oz; Fresh Grab Ham & Provolone Item # 251745, Net Wt 6 oz; Core-Mark Ham & Provolone Item # 568343, Net Wt 6 oz;
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1850-2017·2017-04-12

    Biery Cheese Recalls Colby Jack Trim Due to Listeria Risk

    Biery Cheese, Inc. is recalling Colby Jack Trim For Sale because the supplier reported the product tested positive for Listeria monocytogenes.

    Product
    Colby Jack Trim For Sale
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1857-2017·2017-04-12

    Vulto Creamery Recalls Blue Blais Cheese Due to Listeria Risk

    Vulto Creamery is recalling 13 wheels of Blue Blais artisanal cheese due to Listeria monocytogenes contamination. The product was sold nationwide, primarily in the Northeast, Mid-Atlantic, California, and Chicago.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, Blue Blais
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1838-2017·2017-04-12

    Biery Cheese Recalls Delallo Premium Sliced Colby Cheese for Listeria

    Biery Cheese, Inc. is recalling Delallo Premium Sliced Colby Cheese because the product tested positive for Listeria monocytogenes.

    Product
    DELALLO Premium Sliced COLBY CHEESE NET WT. 8 OZ. (227G) INGREDIENTS: Cultured Pasteurized Milk, Salt, Enzymes, Annatto Color CONTAINS: MILK GEORGE DELALLO CO., INC., JEANNETTE, PA 15644 UPC 0 72368 12452 0
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1841-2017·2017-04-12

    Biery Cheese Recalls Pepper Jack Cheese Due to Listeria Risk

    Biery Cheese, Inc. is recalling Dietz & Watson Pepper Jack Cheese because the supplier reported positive tests for Listeria monocytogenes.

    Product
    DIETZ & WATSON Pepper Jack Cheese NET WT. 8 OZ. (227G) INGREDIENTS: Cultured Pasteurized Milk, Jalapeno Peppers, Salt, Enzymes. CONTAINS: MILK DISTRIBUTED BY: DIETZ AND WATSON, INC. PHILADELPHIA, PA 19135 UPC 0 31506 79450 6
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1855-2017·2017-04-12

    Vulto Creamery Recalls Willowemoc Artisanal Cheese Due to Listeria Risk

    Vulto Creamery is recalling 58 wheels of Willowemoc artisanal cheese due to potential Listeria monocytogenes contamination. The product was distributed nationwide, primarily in the Northeast, Mid-Atlantic, California, and other specific regions.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, Willowemoc, NET WT. 8-10 lbs @ 10" diameter
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1854-2017·2017-04-12

    Vulto Creamery Handmade Cheese Recalled for Listeria Monocytogenes Contamination

    Vulto Creamery is recalling handmade artisanal cheese due to Listeria monocytogenes contamination. The recall covers 908 wheels distributed nationwide.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, heinennellie, NET WT. 1) 1.25 lbs @ 5" diameter & 2) 2.00 lbs @ 7" diameter
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1849-2017·2017-04-12

    Biery Cheese Recalls Private Selections Hardwood Smoked Gouda for Listeria

    Biery Cheese, Inc. is recalling Private Selections Hardwood Smoked Gouda because the supplier reported the cheese tested positive for Listeria monocytogenes.

    Product
    Private Selections HARDWOOD SMOKED GOUDA NET WT 8 OZ (226g) DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45202 UPC 0 11110 60861 1
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-0642-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling 490 bags of Vancomycin HCl IV solution due to the presence of particulate matter, linked to a related Hospira recall.

    Product
    Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1829-2017·2017-04-12

    Lipari Foods Recalls Ready-to-Eat Sandwiches Due to Listeria Risk

    Lipari Foods is recalling specific lots of Asiago Italian sandwiches because a supplier recalled cheese contaminated with Listeria monocytogenes.

    Product
    Premo Asiago Italian Item # 207919, Net Wt 6 oz; Fresh Grab Asiago Italian Item # 251847, Net Wt 6 oz; Core-Mark Asiago Italian Item # 568377, Net Wt 6 oz;
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1832-2017·2017-04-12

    Lipari Foods Recalls Italian Flatbread Sandwiches Due to Listeria Risk

    Lipari Foods is recalling specific lots of Italian flatbread sandwiches because a supplier recalled cheese containing Listeria monocytogenes.

    Product
    Coffee House Italian Flatbread , Item # 226323 net wt. 6 oz.; Fresh Grab Italian Flatbread , Item # 252323 net wt. 6 oz.
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1845-2017·2017-04-12

    Biery Cheese Recalls Marketside Colby Jack for Listeria

    Biery Cheese, Inc. is recalling Marketside Grab and Go Colby Jack cheese because the product tested positive for Listeria monocytogenes.

    Product
    Marketside Grab and Go Colby Jack 10.8 oz Set Ups
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-0644-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling Vancomycin HCl IV bags due to the presence of particulate matter, linked to a related Hospira recall.

    Product
    Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0646-2017·2017-04-12

    FDA Recalls XtraHRD Male Enhancement Capsules for Unapproved Drug Ingredient

    Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules because they contain N-desmethyl tadalafil, an unapproved drug ingredient.

    Product
    XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1839-2017·2017-04-12

    Biery Cheese Recalls Delallo Hot Pepper Cheese for Listeria

    Biery Cheese, Inc. is recalling Delallo Premium Sliced Hot Pepper Cheese because the product tested positive for Listeria monocytogenes.

    Product
    DELALLO Premium Sliced HOT PEPPER CHEESE NET WT. 8 OZ. (227G) INGREDIENTS: American Cheese, Cultured Pasteurized Milk, Salt, Enzymes, Jalapeno Peppers***Red Bell Peppers***CONTAINS: MILK GEORGE DELALLO CO., INC., JEANNETTE, PA 15644 UPC 0 72368 12462 9
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-1744-2017·2017-04-12

    Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise

    Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1843-2017·2017-04-12

    Biery Monterey Jack Cheese with Jalapenos Recalled for Listeria

    Biery Cheese is recalling GFS Monterey Jack Cheese with Jalapeno Peppers because supplier tests detected Listeria monocytogenes.

    Product
    GFS Monterey Jack Cheese with Jalapeno Peppers NET WT. 24 OZ (1.lb 8 OZ) INGREDIENTS: PASTEURIZED MILK, JALAPENO PEPPERS, CHEESE CULTURE, SALT AND ENZYMES. CONTAINS: MILK DISTRIBUTED EXCLUSIVELY BY: GORDON FOOD SERVICE GRAND RAPIDS, MI 49548 UPC 0 93901 77758 4
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-1739-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0641-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling 716 bags of Vancomycin HCl IV solution due to the presence of particulate matter.

    Product
    Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1842-2017·2017-04-12

    Biery Cheese Recalls Finlandia Sriracha and Jalapeno Jack Cheese for Listeria

    Biery Cheese, Inc. is recalling Finlandia Sriracha Jack and Jalapeno Jack cheese because the products tested positive for Listeria monocytogenes.

    Product
    FINLANDIA SRIRACHA JACK & JALAPENO JACK CHEESE NET WT. 12 OZ. (340g) SRIRACHA JACK INGREDIENTS: PASTEURIZED MILK, CULTURES, SALT, JALAPENOS, CAYENNE GARLIC, CITRUS POWDER, ENZYMES CONTAINS: MILK JALAPENO JACK INGREDIENTS: PASTEURIZED MILK, RED AND GREEN JALAPENO PEPPERS, CULTURE
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1840-2017·2017-04-12

    Biery Cheese Recalls Listeria-Positive Cheddar Cheese with Jalapeno and Cayenne

    Biery Cheese, Inc. is recalling Dietz & Watson cheddar cheese with jalapeno and cayenne after the supplier reported positive Listeria monocytogenes test results.

    Product
    DIETZ & WATSON Pasteurized Process New York State Cheddar Cheese with Jalapeno & Cayenne NET WT. 8 OZ. (227G) INGREDIENTS: Aged Cheddar Cheese, (Milk, Cultures, Salt, Enzymes), Jalapeno Peppers, Red Cayenne Pepper Flakes, Sodium Phosphate, CONTAINS: MILK DISTRIBUTED BY: DIETZ AN
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1844-2017·2017-04-12

    Biery Cheese Recalls Marketside Colby Sharp Cheddar for Listeria

    Biery Cheese, Inc. is recalling Marketside Grab and Go Colby Sharp Cheddar cheese because the supplier reported the product tested positive for Listeria monocytogenes.

    Product
    Marketside Grab and Go Col. Sharp Cheddar 10.8 oz Set Ups
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0648-2017·2017-04-12

    Genentech Recalls Cotellic Tablets Due to Oversized Tablet Discovery

    Genentech is recalling 748 bottles of Cotellic (cobimetinib) tablets because an oversized tablet was found in a bottle. The affected product was distributed in New Jersey and Illinois.

    Product
    COTELLIC — COTELLIC (COBIMETINIB)
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0638-2017·2017-04-12

    Hospira Recalls Vancomycin Hydrochloride Injection Due to Particulate Matter

    Hospira is recalling 30,880 vials of Vancomycin Hydrochloride for Injection because a hair was found inside a vial and contacted the drug.

    Product
    Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V252000·2017-04-12

    Mercedes-Benz Recalls Vehicles for Steering Coupling Bolt Tightening Issue

    Mercedes-Benz is recalling specific 2013-2015 models because an insufficiently tightened steering bolt may cause loss of steering, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C300, GLK250, AMG C63, C250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1847-2017·2017-04-12

    Biery Cheese Recalls Marketside Provolone for Listeria Contamination

    Biery Cheese, Inc. is recalling Marketside Grab and Go No Smoke Provolone because supplier testing detected Listeria monocytogenes.

    Product
    Marketside Grab and Go No Smoke Provolone 10.8 oz Set Ups
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0645-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin HCl IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling 62 bags of Vancomycin HCl 750 mg IV bags due to the presence of particulate matter.

    Product
    Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0639-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.25 g in 5% Dextrose 250 mL due to the presence of particulate matter.

    Product
    Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1745-2017·2017-04-12

    Recall of Curity Saline Dressings Due to Compromised Sterility

    Covidien LLC is recalling Curity Saline Dressings because the sterile barrier was breached, compromising sterility. The recall covers lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debrideme
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin HCl IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.5 gram IV bags due to the presence of particulate matter.

    Product
    Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2017·2017-04-12

    Philips BrightView XCT Gamma Cameras Recalled for Brake Hub Assembly Error

    Philips is recalling 90 BrightView XCT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1743-2017·2017-04-12

    Sterile Saline Dressing Recalled Due to Compromised Sterility Barrier

    FDA is recalling Kerlix Super Sponge Saline Dressings because the sterile barrier is breached, potentially compromising sterility.

    Product
    Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1875-2017·2017-04-12

    IKEA Recalls Chocolate Products Due to Undeclared Milk, Almond, and Hazelnut

    IKEA is recalling specific chocolate products, including Godis Chokladkrokant, due to undeclared milk, almond, and hazelnut ingredients.

    Product
    Godis Chokladkrokant Milk chocolate with butterscotch pieces; Net Wt 15.9 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-1746-2017·2017-04-12

    BD Vacutainer Blood Collection Tubes Recalled for Stopper Pullout Risk

    Becton Dickinson is recalling specific lots of BD Vacutainer Buffered Sodium Citrate blood collection tubes because stoppers may pull out during use.

    Product
    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and proces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1874-2017·2017-04-12

    IKEA Recalls Chocolate Squares for Undeclared Milk, Almond, and Hazelnut

    IKEA is recalling Choklad Lingon & Blabar chocolate squares due to undeclared milk, almond, and hazelnut ingredients.

    Product
    Choklad Lingon & Blabar Assortment of milk chocolate Squares with lingonberry pieces and dark chocolate squares with bilberry pieces; Net Wt 6.3 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-1734-2107·2017-04-12

    Nestle Butterfinger Peanut Butter Crisp Candy Bar Recall for Plastic Pieces

    Nestle USA is recalling Butterfinger Peanut Butter Crisp Chocolate Candy Bars because they may contain small rigid plastic pieces that could cause cuts or lacerations during consumption.

    Product
    Nestle Butterfinger Peanut Butter Crisp Chocolate Candy Bar in 3-pack SharePack (2.01 oz); and in 6-pack Snack Tray (4.02oz)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1862-2017·2017-04-12

    McShare's Nutritional Premix Recalled for Undeclared Soy Ingredient

    McShare's Inc is recalling iXL Advanced Performance Matrix Nutritional Premix because it contains low levels of undeclared soy.

    Product
    iXL Advanced Performance Matrix, Nutritional Premix, Net Wt. 50 lbs., Item No. 136375.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1876-2017·2017-04-12

    IKEA Recalls Chocolate Wafers for Undeclared Hazelnut and Almond

    IKEA is recalling Godis Chokladran chocolate wafers because the packaging fails to declare hazelnut and almond ingredients, posing a risk to consumers with allergies.

    Product
    Godis Chokladran Wafers filled and covered with Milk chocolate; Net Wt 5.9 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-1730-2017·2017-04-12

    Centurion Medical Recalls Post-Op Eye Trays Due to Sterile Packaging Breach

    Centurion Medical Products is recalling 476 Post-Op Eye Trays because the sterile eye pads inside may have had a packaging breach.

    Product
    POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1856-2017·2017-04-12

    Vulto Creamery Andes Cheese Recalled for Listeria Contamination

    Vulto Creamery is recalling Andes artisanal cheese due to Listeria monocytogenes contamination. The product was sold nationwide, primarily in the Northeast, Mid-Atlantic, California, and other specific regions.

    Product
    artisanal cheese VULTO Creamery HANDMADE CHEESE, ANDES, NET WT. 12-13 lbs
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2017·2017-04-12

    Philips Recalls 84 BrightView SPECT Gamma Cameras Due to Brake Hub Defect

    Philips is recalling 84 BrightView SPECT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, an
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1742-2017·2017-04-12

    Recall of Sterile Wound Dressings Due to Compromised Sterility Barrier

    Covidien is recalling Curity Wet Dressings because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

    Product
    Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

    Product
    Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Potential Sterile Packaging Breach

    Centurion Medical Products is recalling 1,692 Convenience Kits containing eye pads due to a potential breach in sterile packaging.

    Product
    OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1837-2017·2017-04-12

    Kwei Chow Mustard Strip Recalled for Undeclared Wheat Allergen

    Kwei Chow Sauce Industry Co., Ltd. is recalling 8,488 jars of Mustard Strip with chili in oil because the product contains undeclared wheat.

    Product
    Kwei Chow brand Mustard Strip with chili in oil, net weight 7.05 Oz, sauce in glass jars, shelf stable
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1734-2017·2017-04-12

    Centurion Medical Recalls Post-Operative Ophthalmic Dressing Kits Due to Sterility Concerns

    Centurion Medical Products is recalling 45 post-operative ophthalmic dressing kits because the eye pads inside may have had a breach in sterile packaging.

    Product
    POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1836-2017·2017-04-12

    Kwei Chow Mustard Bamboo Shoots Recalled for Undeclared Wheat

    Kwei Chow Sauce Industry Co., Ltd. is recalling specific jars of Mustard Bamboo Shoots with chili in oil because they contain undeclared wheat.

    Product
    Kwei Chow brand Mustard Bamboo Shoots with chili in oil, net weight 7.40 Oz, sauce in glass jars, shelf stable
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1835-2017·2017-04-12

    Kwei Chow Prime Spicy Pot Paste Recalled for Undeclared Wheat

    Kwei Chow Sauce Industry Co., Ltd. is recalling Prime Spicy Pot Paste because the product contains undeclared wheat, a major food allergen.

    Product
    Kwei Chow brand Prime Spicy Pot Paste, net weight 7.10 Oz, sauce in glass jars, shelf stable
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1732-2017·2017-04-12

    Centurion Convenience Kits Recalled for Potential Sterile Packaging Breach

    Centurion Medical Products is recalling 588 Convenience Kits containing Curity Oval Eye Pads due to a potential breach in sterile packaging.

    Product
    OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1740-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2017·2017-04-12

    Philips IntelliVue MX4O Monitor Recall for Alarm Failure

    Philips is recalling IntelliVue MX4O Patient Wearable Monitors that may fail to switch to Monitor Mode with audible alarms if the connection to the central system is lost.

    Product
    Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1877-2017·2017-04-12

    IKEA Recalls Choklad Ljus Milk Chocolate for Undeclared Allergens

    IKEA is recalling Choklad Ljus Milk Chocolate bars due to undeclared milk, hazelnut, and almond ingredients.

    Product
    Choklad Ljus Milk Chocolate Net Wt 3.5 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighCPSC·17130·2017-04-12

    Customatic Recalls Adjustable Beds Due to Electric Shock Hazard

    Customatic Beds is recalling about 50,000 adjustable bed bases because side-mounted AC outlets may be incorrectly wired, posing an electric shock hazard.

    Product
    Adjustable beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1873-2017·2017-04-12

    IKEA Recalls Dark Chocolate Bars for Undeclared Milk, Almond, and Hazelnut

    IKEA is recalling specific dark chocolate bars because they contain undeclared milk, almond, and hazelnut. Consumers with allergies to these ingredients should not eat the product.

    Product
    Dark Chocolate bars Choklad Mork Dark Chocolate, Net Wt. 3.5 OZ. AND Chokland Mork Dark Chocolate 70%, Net Wt. 3.5 OZ. Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-1752-2017·2017-04-12

    Philips BrightView X Gamma Camera Recall for Brake Hub Assembly Error

    Philips is recalling BrightView X 3/4 gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, an
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1731-2017·2017-04-12

    Centurion Ophthalmic Dressing Kits Recalled for Sterile Packaging Breach

    Centurion Medical Products is recalling 210 ophthalmic dressing kits due to a potential breach in the sterile packaging of the included eye pads.

    Product
    OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1736-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Sterile Packaging Breach

    Centurion Medical Products is recalling 540 Convenience Kits containing eye pads due to a potential breach in sterile packaging.

    Product
    CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1878-2017·2017-04-12

    IKEA Recalls Chocolate Products for Undeclared Milk, Almond, and Hazelnut Allergens

    IKEA is recalling specific chocolate products due to undeclared milk, almond, and hazelnut allergens. Consumers with allergies should not consume these items.

    Product
    Choklad Not; Milk Chocolate with hazelnut Net Wt 3.5 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-1861-2017·2017-04-12

    Amish Bakery Chocolate Chip Bar Recalled for Missing Soy Label

    Original Amish Bakery LLC is recalling Chocolate Chip Grand-ola Bars because the label failed to list soy as an ingredient.

    Product
    Schlabach Amish Bakery Chocolate Chip Grand-ola Bar NET WT. 2.8 OZ (80g) UPC 0 14757 13000 2 Contains: Wheat, Tree Nuts, Dairy Ingredients: Oats, chocolate chips (sugar,chocolate liquor, cocoa butter, whole milk, lecithin [an emulsifier], salt, vanilla), brown sugar, wheat, corn
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1826-2017·2017-04-12

    Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars Recalled for Almond Mislabeling

    Nestle USA is recalling Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars because two consumers found almond bars in the packaging. The product was distributed in eight states and Washington, D.C.

    Product
    Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars; 3 - 3 FL oz.. bars (9 FL ox (266 ml)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1717-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1719-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Errors

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi French SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Turkish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1721-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi German SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1713-2017·2017-04-12

    BioMerieux Recalls NucliSENS Lysis Buffer Due to Colored Eluates

    BioMerieux SA is recalling NucliSENS Lysis Buffer because colored eluates were observed during whole blood extractions.

    Product
    NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1748-2017·2017-04-12

    Siemens ADVIA Centaur BR Assay Recalled for Potential Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.

    Product
    Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, AD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2017·2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) 90 mg extended-release tablets because residual sorafenib powder was found in the manufacturing equipment's inlet air duct.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0647-2017·2017-04-12

    Fresenius Kabi Recalls Subpotent Fluphenazine Decanoate Injection Vials

    Fresenius Kabi USA is recalling 118,224 vials of Fluphenazine Decanoate Injection because the drug was found to be subpotent.

    Product
    Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1737-2017·2017-04-12

    Agilent Bond Elut OMS Cards Recalled for Lack of FDA Clearance

    Agilent Technologies is recalling Bond Elut OMS cards because they were marketed without the required FDA 510(k) clearance.

    Product
    Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS C
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1712-2017·2017-04-12

    Siemens ADVIA Chemistry Enzyme 2 Calibrator Recalled for Positive Bias

    Siemens is recalling ADVIA Chemistry Enzyme 2 Calibrators due to a positive bias of up to 41% in AST and AST_c assay results.

    Product
    ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Spanish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1723-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Issues

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpreted instructions may cause tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Japanese SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinc
    Category
    Medical Device
    Distribution
    Distributed nationwide

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