The Recall Desk

Archive

January 2016 recalls

400 recalls were announced in January 2016.

What the numbers show

Critical
14
Severe
111
High
159
Moderate
107
Low
9

Of the 400 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.

Which agencies issued them

201–300 of 400

  • ModerateFDA (Food)·F-0486-2016·2016-01-20

    Garden Harvest Tomato Salsa Recalled for Unlicensed Acidified Food Manufacturing

    Garden Harvest is recalling tomato salsa because the firm was manufacturing acidified foods without a license. The product was distributed in Ohio, Florida, and West Virginia.

    Product
    Keim's Garden Harvest tomato salsa 1 PT (14 oz 397g) Ingredients: tomatoes, onions, peppers, herbs***Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 mild UPC 6 09722 32345 1 medium UPC 6 09722 32343 7, hot UPC 6 09722 32344 4
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0620-2016·2016-01-20

    Boston Scientific MRI PROPONENT SR Pacemaker Recall for Incorrect Literature Labeling

    Boston Scientific is recalling five MRI PROPONENT SR pacemakers because the included literature incorrectly describes the device's pacing mode.

    Product
    Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0468-2016·2016-01-20

    Northwest Mothers Milk Bank Recalls Pasteurized Donor Human Milk

    Northwest Mothers Milk Bank is recalling 51 bottles of pasteurized donor human milk distributed in Oregon after a hospital reported a foreign particle in one bottle.

    Product
    Pasteurized Donor Human Milk, Frozen then thawed. Product is packaged in 4 oz. glass bottle with metal lid and plastic seal. A bar code is present on each label but there is NO UPC codes.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0496-2016·2016-01-20

    Garden Harvest Recalls RJ's Diavolo Sauce for Unlicensed Acidified Food Production

    Garden Harvest is recalling RJ's Diavolo Sauce with Peppers because the firm was manufacturing acidified foods without a license.

    Product
    RJ's DIAVOLO SAUCE WITH PEPPERS 25 oz INGREDIENTS: ground unpeeled vine-ripened tomatoes, tomato puree, tomato past, Hungarian hot wax peppers, Cubanelle peppers, fresh sweet onions, fresh garlic,***Manufactured for: RJ's Pepper Pantry Warren, OH 44484 Phone 330-765-2863 Mild UPC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0632-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error

    Perkinelmer is recalling 47 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0471-2016·2016-01-20

    Garden Harvest Recalls Unlicensed Acidified Salsa Products

    Garden Harvest is recalling 45 cases of A Bit of a Bite Salsa Melissa Medium because the firm was manufacturing acidified foods without a license.

    Product
    A BIT OF A BITE SALSA MELISSA MEDIUM NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS, FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95416 7
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0654-2016·2016-01-20

    Zimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch

    Zimmer Biomet is recalling 52 orthopedic plates because the package labels did not match the products inside.

    Product
    Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractu
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-0501-2016·2016-01-20

    Keim's Garden Harvest Pickled Jalapeno Eggs Recalled for Unlicensed Manufacturing

    Garden Harvest is recalling pickled spicy jalapeno eggs because the firm was manufacturing acidified foods without a license.

    Product
    Keim's Garden Harvest pickled spicy jalapeno eggs Ingredients: eggs, water, vinegar, sugar, salt, spices, peppers, pepper oil, yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83460
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0476-2016·2016-01-20

    Garden Harvest Recalls Bino's Italian Hot Peppers for Unlicensed Manufacturing

    Garden Harvest is recalling Bino's Italian Hot Peppers because the firm was manufacturing acidified foods without a license.

    Product
    BINO'S ITALIAN HOT PEPPERS Ingredients: Hungarian hot peppers w/seeds, onions, vinegar, garlic, sugar, Bell peppers, tomato sauce, tomato puree, salt and olive oil. NET WT 16 oz UPC 8 67752 00013 5 NET WT 32 oz UPC 8 67752 00011 1
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0566-2016·2016-01-20

    Teva Recalls Amphetamine Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 9,717 bottles of mixed amphetamine salts tablets because stability testing revealed high impurity levels.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V019000·2016-01-19

    Western Trailer Chip B-Train Recalled for Brake Drag Fire Risk

    Western Trailer is recalling 2015-2016 Chip B-Train trailers due to brake drag that may cause wheel end fires. Brake chambers have already been replaced.

    Product
    WESTERN TRAILER — WESTERN TRAILER CHIP B-TRAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V018000·2016-01-19

    Suzuki Recalls Motorcycles Due to Electrical System Defect

    Suzuki is recalling certain 2008-2012 motorcycles because a faulty regulator/rectifier may cause the engine to stall while riding, increasing crash risk.

    Product
    SUZUKI — SUZUKI VLR1800, DL1000, GSX1300R, GSF1250S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16077·2016-01-19

    West Elm Recalls Saddle Bar and Counter Stools Due to Fall Hazard

    West Elm is recalling Saddle bar and counter stools because the legs can break, posing a fall hazard. The firm received six reports of breaking, including one injury.

    Product
    Saddle bar and counter stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E002000·2016-01-19

    Mazda CX-5 Windshield Recall Due to Improperly Affixed Sensor Bracket

    Pilkington is recalling replacement windshields for Mazda CX-5 vehicles because the Smart City Brake Support sensor bracket may loosen, potentially disabling safety features.

    Product
    MAZDA — MAZDA CX-5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·006-2016·2016-01-16

    Kayem Foods Recalls Chicken Sausage Due To Misbranding And Undeclared Pork

    Kayem Foods Inc. is recalling approximately 22,182 pounds of chicken sausage products due to incorrect nutritional labeling and undeclared pork casings.

    Product
    Kayem Foods Inc. — Kayem Foods Inc. Recalls Chicken Sausage Products Due To Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V015000·2016-01-15

    Coachmen Cross Country Recalled for Fuel Guard Tire Damage Risk

    Forest River is recalling 2016 Coachmen Cross Country vehicles because the fuel fill guard may damage front tires, increasing crash risk.

    Product
    COACHMEN — COACHMEN CROSS COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V014000·2016-01-15

    Supreme Recalls Shuttle Buses Due to Wheelchair Lift Bearing Defect

    Supreme is recalling 2008-2014 shuttle buses equipped with certain Ricon wheelchair lifts because pivot holes may allow bearings to move, risking platform failure.

    Product
    STARTRANS — STARTRANS CANDIDATE, SENTINEL BUS, AZURE HYBRID, PRESIDENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V012000·2016-01-14

    Eldorado Recalls 2010-2016 Buses Due to Seat Belt Anchor Weld Defect

    Eldorado is recalling specific 2010-2016 bus models because missing welds on seat brackets could cause seat belts to detach during a crash.

    Product
    ELDORADO — ELDORADO AXESS, EZRM, XHF, ARRIVO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16074·2016-01-14

    Steelcase Recalls Rocky Swivel Chairs Due to Fall Hazard

    Steelcase is recalling about 17,000 Rocky model swivel chairs because screws can detach, posing a fall hazard. One injury was reported.

    Product
    Rocky model swivel chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16721·2016-01-14

    School Specialty Recalls NeoRok Stools Due to Fall Hazard

    School Specialty is expanding a recall of NeoRok stools that can break during use, posing a fall hazard to children.

    Product
    Classroom Select NeoRok Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0465-2016·2016-01-13

    Casey's Bakery Recalls Snickers Cakes Due to Undeclared Peanuts

    Casey's Bakery is recalling 8x8 Snickers cakes because they contain undeclared peanuts. Consumers in the Sioux Center, IA area should not eat these products.

    Product
    Casey's Bakery, 8X8 Snickers cake, www.caseysbakery.com, Sioux Center, IA
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0464-2016·2016-01-13

    Skinny Latina Marinade Recalled for Undeclared Soy Allergen

    Skinny Latina LLC is recalling 18,822 bottles of Million Dollar Marinade due to undeclared soy. The product was sold at Target, Whole Foods, and Fresh Market.

    Product
    Skinny Latina Million Dollar Marinade, 12 oz, shelf stable, dry storage.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0428-2016·2016-01-13

    Pine Valley Foods Recalls Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie kits because they contain undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb Fairytale Princess COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4031 UPC Code - 698768034315
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V011000·2016-01-13

    Gillig Recalls 2010-2015 Low Floor Buses Due to Seat Belt Defect

    Gillig is recalling 6,734 Low Floor transit buses from 2010-2015 because missing welds on seat brackets could cause seat belts to detach during a crash.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0588-2016·2016-01-13

    Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter Recall for Handle Separation

    Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.

    Product
    Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0433-2016·2016-01-13

    Pine Valley Foods Recalls Cookie Dough for Undeclared Milk and Egg

    Pine Valley Foods is recalling specific batches of pre-portioned cookie dough because they contain undeclared milk or egg allergens.

    Product
    Crazy about Cookies 2.7lb WALNUT CHUNKY CHOCOLATE CHIP Pre-Portioned cookie dough Item # 25-2008 UPC Code - 698768102168
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0478-2016·2016-01-13

    Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion

    Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.

    Product
    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-0420-2016·2016-01-13

    ConAgra Recalls David Trail Mix Sweet & Salty for Undeclared Milk

    ConAgra Foods is recalling David Trail Mix Sweet & Salty bags because they contain undeclared milk. The product was distributed nationwide and to specific foreign locations.

    Product
    David Trail Mix Sweet & Salty individual plastic bags net wt. 5 oz. (142 g) UPC 00 26200 23885 2 shipped in the following configurations: 1) cases of eight (8) with UPC 20-0-26200-23885-6; 2) 36-count multi-pack shipper case UPC 00-0-26200-23890-6 which contains 16 individu
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0431-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific Hello Kitty sugar cookie kits because they contain undeclared milk and egg.

    Product
    Crazy about Cookies 2lb HELLO KITTY COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4035 UPC Code - 698768034353
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V008000·2016-01-13

    Newmar Recalls Motorhomes Due to Unstable Electric Entry Steps

    Newmar is recalling specific 2008-2015 motorhomes because a bolt on the electric steps may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    NEWMAR — NEWMAR BAY STAR, DUTCH STAR, VENTANA, CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V010000·2016-01-13

    Champion Bus Recalls 2009-2015 Models Due to Seat Belt Anchor Defect

    Champion Bus is recalling 2009-2015 Crusader, Stacked Rail, and CTS-RE vehicles because missing welds on seat brackets could cause seat belts to detach in a crash.

    Product
    CHAMPION — CHAMPION CRUSADER, STACKED RAIL, CTS-RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2016·2016-01-13

    Maquet HCU 30 Heater-Cooler Unit Recalled for Power Supply Board Failure

    Maquet is recalling HCU 30 Heater-Cooler Units due to a power supply board defect that can cause overheating and unit shutdown during cardiopulmonary bypass procedures.

    Product
    Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0335-2016·2016-01-13

    Made In Nature Recalls Sriracha Kale Chips Due to Undeclared Soy Allergen

    Made In Nature is recalling Sriracha Chili Kale Chips and Pacific Superfoods Snack Lava Rock Sriracha Kale Chips because they contain undeclared soy from Tamari.

    Product
    Pacific Superfoods Snack Lava Rock Sriracha Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling specific Post-Operative Knee Brace Lite models because they may fail to maintain the locked position, potentially causing loss of balance or undesired knee movement.

    Product
    ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral frac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2016·2016-01-13

    3M Coban Self-Adherent Wrap Recalled for Latex Mislabeling

    3M is recalling Coban Self-Adherent Wrap mislabeled as latex-free because it actually contains latex, posing a risk to users with latex sensitivity.

    Product
    3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0595-2016·2016-01-13

    Benlan Pediatric Feeding Tubes Recalled for Incorrect Size Packaging

    Benlan, Inc. is recalling specific lots of 8 FR pediatric feeding tubes that may be packaged with 5 or 6.5 FR tubes instead.

    Product
    MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0578-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 10 units of the Brielle Ortho Contender Post-Op-Knee Brace Lite because the brace may fail to maintain its locked position, potentially causing loss of balance or undesired knee movement.

    Product
    BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2016·2016-01-13

    Partners In Medicine Recalls CNSystems Task Force Monitor 3040i for Blood Pressure Errors

    Partners In Medicine is recalling 28 CNSystems Task Force Monitor 3040i devices because they may provide incorrect blood pressure readings for some patients.

    Product
    CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0594-2016·2016-01-13

    Biomet 3i Recall Dental Impression Coping Kits for Biocompatibility Testing

    Biomet 3i is recalling 30,111 Provide Impression Coping Kits worldwide due to inadequate biocompatibility testing.

    Product
    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0466-2016·2016-01-13

    Kroger Bakery Fresh Goodness Chocolate Brownie Recalled for Undeclared Walnuts

    The Kroger Co is recalling Bakery Fresh Goodness Chocolate Brownies because a consumer reported undeclared walnuts in the product.

    Product
    BAKERY FRESH GOODNESS Chocolate Brownie NET WT 16 OZ (1 LB) 453 g CONTAINS: MILK, EGGS, WHEAT, SOY. MAY CONTAIN: ALMONDS, PECANS, WALNUTS, CASHEWS, COCONUT. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 09172 7
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0432-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookies for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie products due to undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb DSC Custom Decorated Sugar Cookies Item # 101-2207 thru 101- 2355 UPC Code - None
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V009000·2016-01-13

    Turtle Top Recalls Wheelchair Lifts Due to Bearing Failure Risk

    Turtle Top is recalling specific wheelchair lifts installed in Odyssey and Terra Transport vehicles because pivot holes may allow bearings to move, risking platform failure.

    Product
    TURTLE TOP — TURTLE TOP ODYSSEY XL, ODYSSEY LT, ODYSSEY, TERRA TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0334-2016·2016-01-13

    Made In Nature Recalls Sriracha Chili Kale Chips for Undeclared Soy

    Made In Nature is recalling Sriracha Chili Kale Chips due to undeclared soy allergen from Tamari. The recall covers 50,176 units distributed nationwide.

    Product
    Made In Nature Sriracha Chili Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2016·2016-01-13

    Smith & Nephew Recalls Mislabelled 35mm Patellar Knee Implant Components

    Smith & Nephew is recalling 20 units of 35mm patellar knee implants incorrectly labeled as 32mm. The size mismatch prevents proper alignment of pegs during surgery.

    Product
    Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0605-2016·2016-01-13

    Baxter Y-Type Spike Adapter Recalled for Potential Particulate Matter

    Baxter Healthcare is recalling Y-Type Spike Adapters due to the potential presence of dark loose particulate matter on the spike.

    Product
    Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2016·2016-01-13

    Biomet 3i Protection Cap Kits Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling 30,111 Protection Cap Kits worldwide due to inadequate biocompatibility testing. The devices are used as accessories for dental implants.

    Product
    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0593-2016·2016-01-13

    Biomet 3i Dental Impression Copings Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling specific dental impression copings due to inadequate biocompatibility testing. The devices are distributed worldwide, including in the US.

    Product
    BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2016·2016-01-13

    Elekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error

    Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system because a software error may cause the system to incorrectly include organs at risk as target volumes.

    Product
    Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0430-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie kits because they contain undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb Birthday Celebration COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4033 UPC Code - 698768034339
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0427-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie kits because they contain undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb Holiday Gathering COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4034 UPC Code - 698768034346
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0426-2016·2016-01-13

    Pine Valley Foods Recalls Sugar and Walnut Cookie Dough for Allergens

    Pine Valley Foods is recalling pre-portioned sugar and walnut chocolate chunk cookie dough because they contain undeclared milk and egg, respectively.

    Product
    Crazy about Cookies 2.7lb Sugar Cookies Pre-Portion Item # 25-2004 UPC Code - 698768102120
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0429-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie kits because they contain undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb Monster Bash COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4032 UPC Code - 698768034322
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0576-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling specific models of the Hailey Ortho Contender Post-Op Knee Brace because they may fail to maintain a locked position, risking loss of balance or unwanted joint movement.

    Product
    HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fract
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 80 post-operative knee braces that may fail to maintain the locked position, potentially causing loss of balance or undesired knee movement.

    Product
    CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0574-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 1,406 post-operative knee braces because they may fail to maintain a locked position, potentially causing loss of balance or undesired knee movement.

    Product
    Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling specific Post-Operative Knee Braces because they may fail to maintain a locked position, potentially causing loss of balance or unwanted knee movement.

    Product
    CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 42 units of the Contender Post-Op-Knee Brace Lite because the brace may fail to maintain its locked position, potentially causing loss of balance or undesired knee movement.

    Product
    ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2016·2016-01-13

    Philips Lumify Diagnostic Ultrasound Recalled for Color Flow Display Error

    Philips is recalling 21 Lumify Diagnostic Ultrasound units in the US because a software error displays Color Flow direction incorrectly, which could lead to misdiagnosis.

    Product
    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0618-2016·2016-01-13

    Siemens Acute Care MYO DilPak Recall Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 192 units of Acute Care MYO DilPak in vitro diagnostic products because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0600-2016·2016-01-13

    KCI ActiV.A.C. Canisters Recalled for Potential Pinhole Leaks

    KCI USA is recalling ActiV.A.C. 300ml Canisters distributed in Japan and Australia due to potential pinhole leaks in the pouches.

    Product
    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connecte
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0561-2016·2016-01-13

    PD-Rx Pharmaceuticals Recalls Azithromycin 500 mg Tablets for cGMP Deviations

    PD-Rx Pharmaceuticals is recalling Azithromycin 500 mg tablets because the original manufacturer did not adequately investigate customer complaints, resulting in cGMP deviations.

    Product
    Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2016·2016-01-13

    Baxter INTERLINK Y-Type Solution Set Recalled for Particulate Matter

    Baxter Healthcare is recalling INTERLINK Y-Type Solution Sets due to potential dark particulate matter on the spike adapter.

    Product
    Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2016·2016-01-13

    Siemens Acute Care CTNI TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics Inc is recalling 5,558 units of the Acute Care CTNI TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2016·2016-01-13

    Siemens Acute Care MYO TestPak Barcode Labels May Not Scan

    Siemens Healthcare Diagnostics Inc is recalling 608 units of Acute Care MYO TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0582-2016·2016-01-13

    Vidco MDP 2000 Remote Patient Monitoring Systems Recalled for Freezing

    Vidco, Inc. is recalling 59 MDP 2000 Series Remote Patient Monitoring Systems because they may freeze and fail to reset without a power cycle.

    Product
    Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2016·2016-01-13

    Biomet 3i Protection Caps Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling specific Protection Caps due to inadequate biocompatibility testing. The devices are distributed worldwide, including the US.

    Product
    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accesso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0614-2016·2016-01-13

    Siemens Acute Care CCRP TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0603-2016·2016-01-13

    Steris Amsco Warming Cabinet Recalled for Incorrect Temperature Labeling

    Steris Corporation is recalling Amsco Warming Cabinets because the quick reference magnet displays incorrect Fahrenheit to Celsius conversions and default temperatures.

    Product
    AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0467-2016·2016-01-13

    Nicomex Velitas Candies Candles Recalled for Undeclared Food Dyes

    Nicomex Inc. is recalling Velitas Candies Candles because laboratory analysis found undeclared FD&C Red #3 and Yellow #5 dyes.

    Product
    Nicomex Velitas Candies Candles Net. Wt. 2 oz (56.7 gms) Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0584-2016·2016-01-13

    Smith & Nephew Recalls Mislabelled Birmingham Hip Resurfacing Modular Heads

    Smith & Nephew is recalling 16 Birmingham Hip Resurfacing Modular Heads in the US because they were incorrectly labeled as a different device type not cleared for US marketing.

    Product
    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM 74121338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2016·2016-01-13

    Siemens Acute Care CKMB DilPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2016·2016-01-13

    Siemens Acute Care BHCG TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2016·2016-01-13

    Baxter CLEARLINK Blood Bag Spike Adapter Recalled for Particulate Matter

    Baxter Healthcare is recalling CLEARLINK Blood Bag Spike Adapters due to potential dark loose particulate matter on the spike.

    Product
    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0560-2016·2016-01-13

    PD-Rx Recalls Azithromycin Tablets Due to Inadequate Complaint Investigation

    PD-Rx Pharmaceuticals is recalling 45,022 bottles of Azithromycin Tablets, USP, 250 mg, because the manufacturer did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0590-2016·2016-01-13

    Zimmer NexGEN Tibial Components Recalled Due to Labeling Error

    Zimmer Manufacturing B.V. is recalling specific NexGEN System tibial components because a carton was mislabeled, containing a different component than indicated.

    Product
    NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0602-2016·2016-01-13

    Ethicon Recalls Gynecare Thermachoice III Uterine Balloon Therapy System

    Ethicon, Inc. is recalling the Gynecare Thermachoice III Uterine Balloon Therapy System because stability data does not support the labeled two-year shelf life.

    Product
    Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (exc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0608-2016·2016-01-13

    Otto Bock Recalls Modular Polycentric EBS Knee Joints Due to Service Error

    Otto Bock is recalling 40 Modular Polycentric EBS Knee Joints serviced between April 2015 and November 2015 because the wrong Loctite was used during repair.

    Product
    Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2016·2016-01-13

    Siemens Acute Care DDMR TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics is recalling Acute Care DDMR TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0610-2016·2016-01-13

    Siemens Acute Care pBNP TestPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 1,157 Acute Care pBNP TestPaks because their barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0597-2016·2016-01-13

    Siemens Syngo X-Workplace Software Recall for Incorrect Measurement Display

    Siemens is recalling Syngo X-Workplace software version VD10E because it may display incorrect length measurements, potentially leading to the selection of medical devices of the wrong size.

    Product
    Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2016·2016-01-13

    Siemens Acute Care CKMB TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 1,051 units of Acute Care CKMB TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2016·2016-01-13

    Siemens Acute Care BHCG CalPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0585-2016·2016-01-13

    Synthes 13.5mm Medullary Reamer Head Recalled for Dimensional Mismatch

    Synthes (USA) Products LLC is recalling 65 units of 13.5mm Medullary Reamer Heads that are actually 14mm. The devices are distributed nationwide.

    Product
    SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0616-2016·2016-01-13

    Siemens Acute Care CCRP CalPak Recall for Barcode Scanning Issues

    Siemens is recalling 65 units of Acute Care CCRP CalPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0581-2016·2016-01-13

    Natus Quantum System Recalled for Reversed Signal Polarity Display

    Natus Medical is recalling 56 Quantum Systems with NeuroWorks 8.1 software because incoming signals display with reversed polarity.

    Product
    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with N
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-0583-2016·2016-01-13

    Ultradent Recalls InterGuard Dental Refills Due to Manufacturing Defect

    Ultradent is recalling InterGuard 5.5mm Econo Refills because the floss tether hole was not completely punched through.

    Product
    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0563-2016·2016-01-13

    Avantor Recalls Magnesium Sulfate 7-Hydrate Due to Impurity Failures

    Avantor Performance Materials is recalling 265 drums of Magnesium Sulfate 7-Hydrate for parenteral use because the product failed impurity specifications.

    Product
    Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-0562-2016·2016-01-13

    Freedom Pharmaceuticals Recalls Subpotent 5-methyltetrahydrofolate Calcium Drug

    Freedom Pharmaceuticals is voluntarily recalling specific lots of 5-methyltetrahydrofolate Calcium because the drug was found to be subpotent.

    Product
    5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, Ch
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0564-2016·2016-01-13

    PQ Corporation Recalls Epsom Salt Bags Due to High Iron Levels

    PQ Corporation is recalling 50 lb bags of Epsom Salt because iron levels exceeded USP limits. The product was distributed in Kentucky.

    Product
    EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0599-2016·2016-01-13

    NIPRO SafeTouch II Safety AVF Needle Recall for Torn Wings

    Nipro Medical Corporation is recalling 160,000 NIPRO SafeTouch II Safety AVF Needles because the device has the potential to have torn wings.

    Product
    NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
    Category
    Medical Device
    Distribution
    1 state

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