The Recall Desk

Archive

March 2018 recalls

766 recalls were announced in March 2018.

What the numbers show

Critical
16
Severe
113
High
287
Moderate
299
Low
51

Of the 766 recalls this month scored against our rubric, 2% are Critical, 15% are Severe.

Which agencies issued them

501–600 of 766

  • ModerateFDA (Devices)·Z-0893-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7603G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0929-2018·2018-03-14

    Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives

    Euro Diagnostica is recalling 1,090 units of DIASTAT ANA ELISA kits because high background levels may cause false positive test results.

    Product
    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0603-2018·2018-03-14

    SCA Pharmaceuticals Recalls Labetalol HCl Injection Due to Labeling Errors

    SCA Pharmaceuticals is recalling 480 syringes of labetalol HCl injection because some labels display incorrect compounding and use-by dates.

    Product
    labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-0577-2018·2018-03-14

    Akorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure

    Akorn, Inc. is recalling 31,812 bottles of Atropine Sulfate Ophthalmic 1% Solution because testing revealed low viscosity results.

    Product
    Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0585-2018·2018-03-14

    AstraZeneca Recalls Lynparza Capsules Due to Quality Attribute Deviation

    AstraZeneca is recalling 18,056 bottles of Lynparza (olaparib) capsules 50 mg due to elevated levels of a specific quality attribute.

    Product
    Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0584-2018·2018-03-14

    Life Brand Acne Treatment Stick Recalled for Failed Assay

    Oxygen Development LLC is recalling Life Brand Clear Action Acne Treatment Concealer Sticks because the salicylic acid content failed stability testing.

    Product
    Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653
    Category
    Drug
    Distribution
    0 states
  • HighCPSC·18121·2018-03-13

    SwissStop Bicycle Disc Brake Pads Recalled Due to Fall Hazard

    Helvetia Sports is recalling SwissStop EXOTherm cycling disc brake pads because they can separate from the backplate, posing a fall hazard to users.

    Product
    SwissStop EXOTherm cycling disc brake pads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18120·2018-03-13

    MAAX Spas Recalls Hot Tubs and Swim Spas Due to Fire Hazard

    MAAX Spas is recalling about 550 hot tubs and swim spas in the U.S. because the internal UV generator can ignite, posing a fire hazard.

    Product
    Maax Spas hot tubs and swim spas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V169000·2018-03-12

    Ford Recalls Focus and Fusion Vehicles for Clutch Fracture Risk

    Ford is recalling 2013-2016 Focus and Fusion vehicles with manual transmissions because the clutch may fracture, causing transmission damage and fluid leaks that could lead to fire.

    Product
    FORD — FORD FOCUS, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V163000·2018-03-12

    Freightliner Custom Chassis Recalls 2011-2017 RV Chassis for Fire Risk

    Daimler Trucks North America is recalling 9,480 Freightliner Custom Chassis vehicles due to a power steering hose defect that may cause electrical arcing and fire.

    Product
    FCCC — FCCC XCM, XBR, XCL, XCR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V167000·2018-03-12

    Ford Recalls 2014-2018 Fusion and Lincoln MKZ for Steering Wheel Defect

    Ford is recalling 2014-2018 Fusion and Lincoln MKZ vehicles because the steering wheel bolt may loosen, allowing the wheel to detach and causing loss of control.

    Product
    LINCOLN — LINCOLN, FORD MKZ, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E015000·2018-03-09

    SynTec Recalls S3B School Bus Seats Due to Bracket Crack Risk

    SynTec Seating Solutions is recalling S3B Non-Restraint Wall Mounted Seats because the mounting bracket may crack, increasing injury risk in a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V168000·2018-03-09

    Supreme Trucks Recalled for Defective Kidde Fire Extinguishers

    Supreme Corporation is recalling 2003-2018 trucks equipped with specific Kidde fire extinguishers that may clog or detach, posing injury risks during a fire.

    Product
    SUPREME — SUPREME SERVICE BODY, SIGNATURE VAN, KOLD KING, INER-CITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·020-2018·2018-03-09

    Heartland Catfish Company Recalls Catfish Products Due to Leucomalachite Green Residue

    Heartland Catfish Company is recalling approximately 69,016 pounds of fresh and frozen catfish products that may be adulterated with leucomalachite green, a residue of public health concern.

    Product
    Heartland Catfish Company, LLC — Heartland Catfish Company Recalls Siluriformes Fish Products Due to Possible Adulteration
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·18V162000·2018-03-09

    Forest River Recalls 2018 Stealth Evo Trailers for Incorrect Tire Placards

    Forest River is recalling 2018 Stealth Evo recreational trailers because the federal placard lists incorrect tire sizes. This error could lead owners to install wrong replacement tires, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER STEALTH EVO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V164000·2018-03-09

    Ferrari Recalls 2016 488 GTB and Spider for Brake Warning Software Error

    Ferrari is recalling 2016 488 GTB and 488 Spider vehicles because a software error may prevent drivers from receiving warnings about critically worn brake discs.

    Product
    FERRARI — FERRARI 488 GTB, 488 SPIDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V160000·2018-03-08

    Dodge Ram 1500 Fuel Tank Strap Corrosion Recall

    Chrysler is recalling 2009-2012 Dodge Ram 1500 trucks in 21 states and D.C. because a fuel tank bracket may corrode, causing the tank to drop and leak fuel.

    Product
    DODGE — DODGE, RAM RAM 1500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V159000·2018-03-08

    Volkswagen Recalls 2018 Tiguan Models Due to Engine Support Bolt Issue

    Volkswagen is recalling 2018 Tiguan long wheel base vehicles because engine support bolts may not be properly tightened, which could lead to engine breakdown or loss of power.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E014000·2018-03-08

    ATC Recalls 7-Way Wiring Harnesses for Truck Caps Due to Fire Risk

    American Technology Components is recalling specific 7-Way Wiring Harnesses used for aftermarket truck cap installations because the wiring may overheat, increasing the risk of a fire.

    Product
    ELECTRICAL SYSTEM:WIRING recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18727·2018-03-08

    Golden State Warriors Menorahs Recalled Due to Fire and Burn Hazards

    BDA is recalling Golden State Warriors Menorahs because the glue holding the candleholders can melt, causing lit candles to fall and posing fire and burn risks.

    Product
    Golden State Warriors Menorahs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0551-2018·2018-03-07

    Kareway Recalls Gericare Eyewash Due to Confirmed Microbial Contamination

    Kareway Products Inc. is recalling 60,000 bottles of Gericare Eyewash because testing confirmed the presence of Achromobacter xylosoxidans bacteria.

    Product
    GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0574-2018·2018-03-07

    AuroMedics Recalls Levofloxacin Injection Bags Due to Mold Contamination

    AuroMedics Pharma LLC is recalling 6,072 bags of Levofloxacin in 5% Dextrose Injection because they contain visible particulate matter identified as mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0923-2018·2018-03-07

    Seggiano Artichoke & Garlic Sauce Recalled for Undeclared Cashews

    Seggiano Artichoke & Garlic Sauce & Spread is being recalled because it was mislabeled and contains undeclared cashews.

    Product
    Seggiano Artichoke & Garlic Sauce & Spread Net Weight 200g, 7.1 oz, packaged in Glass jar, UPC Code: 812603020381
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0715-2018·2018-03-07

    Mobius AIRO Mobile CT System Recalled for Unintended Motion Risk

    Mobius Imaging is recalling 105 AIRO Mobile CT Systems due to a risk of unintended device motion during startup or scan preparation.

    Product
    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0817-2018·2018-03-07

    Circulatory Technology Recalls Better-Bladder ECMO Blood Reservoirs

    Circulatory Technology Inc is recalling Better-Bladder cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.

    Product
    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1171-2018·2018-03-07

    Circulatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs

    Circulatory Technology Inc is recalling specific models of cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.

    Product
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Food)·F-0831-2018·2018-03-07

    Sumano's Bakery Recalls Sourdough Baguettes Due to Metal Contamination

    Sumano's Bakery is recalling Sourdough Baguettes because a customer found a small metal piece on the outside of the bread before baking.

    Product
    Sourdough Baguette: Product number 2064; SKU 61659798; GTIN [00046567600949]; UPC 831 49000064 20 pieces; Ingredients: Unbleached Wheat Flour, Water, Sea Salt, Starter (Fermented dough). Best Practices: 1. Keep Bread frozen at all times 2. Pull bread out of freezer
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V155000·2018-03-07

    New Flyer Recalls Transit Buses Due to Drive Shaft End-Cap Failure Risk

    New Flyer is recalling 2016-2018 XDE40, XDE60, and 2017 XDE35 buses because plastic drive shaft end-caps may crack, causing loss of drive power and increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XDE40, XDE60, XDE35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0740-2018·2018-03-07

    Ventana Medical Systems Recalls NEXES VEN IVIEW DAB DET KT JPN-US EXPORT

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT in vitro diagnostic kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0775-2018·2018-03-07

    Zimmer Biomet Recalls 337 Femoral Intramedullary Nail Loaner Kits

    Zimmer Biomet is recalling 337 femoral intramedullary nail loaner kits because the bolt connecting the insertion guide to the nail can fracture during insertion.

    Product
    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E012000·2018-03-07

    S&B Filters Recalls Cold Air Intake Kits for Ford Trucks

    S&B Filters is recalling specific Cold Air Intake Kits for Ford Super Duty trucks because a missing hole in the battery tray may prevent proper grounding, increasing fire risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V156000·2018-03-07

    Nissan Recalls 2011-2012 Juke Vehicles for Fuel Leak Risk

    Nissan is recalling 2011-2012 Juke vehicles because a previous repair may have left the fuel pressure sensor loose, creating a potential fire hazard.

    Product
    NISSAN — NISSAN JUKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0544-2018·2018-03-07

    Acyclovir Tablets Recalled Due to Presence of Torsemide Tablets

    Apace KY LLC is recalling 630 cartons of Acyclovir 400 mg tablets because some blister cavities may contain Torsemide tablets instead.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0719-2018·2018-03-07

    Medistim Veriq System Recalled Due to Component Overheating and Smoke Emission

    Medistim Asa is recalling two Medistim Veriq System units because a component overheated, causing connector melting and smoke emission.

    Product
    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0549-2018·2018-03-07

    B. Braun Recalls Sodium Chloride Irrigation Due to Particulate Matter

    B. Braun Medical Inc. is recalling 17,360 units of 0.9% Sodium Chloride Irrigation USP due to the presence of polyethylene particulate matter.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0732-2018·2018-03-07

    Ventana ultraView SISH Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 6 units of the ultraView SISH Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0774-2018·2018-03-07

    Zimmer Biomet Recalls Antegrade Femoral Nail Instrument Kits

    Zimmer Biomet is recalling 337 Antegrade Femoral Nail Instrument Kits because a bolt may fracture during use, potentially affecting patients undergoing orthopedic surgery.

    Product
    14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2018·2018-03-07

    Siemens CT Table Recalled Due to Potential Bolt Loosening and Instability

    Siemens Medical Solutions is recalling SOMATOM Go.Now CT system tables because bolts may loosen, causing the table to become unstable.

    Product
    SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0730-2018·2018-03-07

    Ventana ultraView Universal DAB Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E013000·2018-03-07

    Norcold Recalls RV Refrigerators Due to Propane Leak Risk

    Norcold is recalling specific RV refrigerators because loose gas valve screws may allow propane to leak into the passenger compartment, creating a fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0738-2018·2018-03-07

    Ventana Hematoxylin II and HRP Dispensers Recalled for Leaking and Sticking

    Ventana Medical Systems is recalling Hematoxylin II and specific HRP dispensers due to increased reports of leaking and sticking.

    Product
    Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0733-2018·2018-03-07

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 20 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0734-2018·2018-03-07

    Ventana Recalls CINtec PLUS Cytology Kit Due to Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 748 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0713-2018·2018-03-07

    Siemens SOMATOM Go.Up CT Table Recall for Potential Instability

    Siemens Medical Solutions is recalling six SOMATOM Go.Up CT system tables because improperly tightened bolts may loosen, causing the table to become unstable.

    Product
    SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0547-2018·2018-03-07

    Fagron Recalls SyrSpend SF Suspending Base Due to Microbial Contamination

    Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product was found to be contaminated with yeast and mold.

    Product
    SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2018·2018-03-07

    Avid Medical Recalls TruCustom CATH PACK Kits Due to Foreign Material

    Avid Medical is recalling 444 TruCustom CATH PACK kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0707-2018·2018-03-07

    Siemens Artis Zee and Zeego Medical Devices Recalled for Liquid Entry Risk

    Siemens Medical Solutions is recalling Artis Zee and Zeego devices due to a potential for liquid entry.

    Product
    Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2018·2018-03-07

    Moog Curlin Infusion Administration Set Recalled for Particulate Matter

    Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets due to particulate matter found on the spike. The recall covers 56,244 cases distributed nationwide and internationally.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2018·2018-03-07

    Stryker Recalls Berchtold Chromophare Monitor Arms Due to Weld Defects

    Stryker Communications is recalling 850 Berchtold Chromophare Dual Monitor Carrier Arms and Flat Panels because the mounts may have missing or incomplete welds.

    Product
    Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2018·2018-03-07

    Philips Intellivue iX Software Recall for Patient Discharge Failure

    Philips is recalling Intellivue iX Information Center Software because restarting stations in 2018 prevents patient discharge and transfer operations, causing monitoring loss.

    Product
    Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Da
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0797-2018·2018-03-07

    Avid Medical Recalls Pacemaker Kits With Foreign Material

    Avid Medical is recalling 8 TruCustom Pacemaker Packs containing needles with loose polypropylene foreign material.

    Product
    AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0810-2018·2018-03-07

    Howmedica Recalls 130 AccuLIF TL Insertion Handles Due to Pivot Defect

    Howmedica Osteonics Corp. is recalling 130 AccuLIF TL Insertion Handles because the implant may pivot instead of maintaining a rigid connection when the lever is locked.

    Product
    AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in t
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V154000·2018-03-07

    BMW Recalls 2018 X3 Models for Potential Rear Spoiler Detachment

    BMW is recalling 2018 X3 xDrive30i and M40i vehicles because the rear spoiler may not be properly attached or may be missing screws, posing a road hazard.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0833-2018·2018-03-07

    Thai Sweet Chili Roasted Pumpkin Seeds Recalled for Undeclared Soy

    La Salsa Foods Inc. is recalling International Food Court brand Thai Sweet Chili Roasted Pumpkin Seeds due to undeclared soybean oil and soy lecithin.

    Product
    Pepitas - International Food Court brand, Thai Sweet Chili Roasted Pumpkin Kernels, 4 oz. vacuum sealed plastic bag, UPC 0 83066 16018 5 The label is read in parts: "***PEPITAS***THAI SWEET CHILI ROASTED PUMPKIN KERNELS***Ingredients: organic pumpkin seeds, pure cane sugar, v
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0796-2018·2018-03-07

    Avid Medical Recalls TruCustom Pacemaker Kits Due to Foreign Material

    Avid Medical is recalling 90 TruCustom Pacemaker Pack convenience kits because they may contain loose polypropylene foreign material in the included needles.

    Product
    AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0878-2018·2018-03-07

    Market of Choice Recalls Sezam Kale Salad Kits for Undeclared Egg

    Market of Choice Inc is recalling 16 kits of Sezam Kale Salad due to undeclared egg in the dressing. The product was distributed in Oregon.

    Product
    Sezam Kale Salad ingredient kits, net wt. 6.43 pound. Ingredients are packaged individually and then placed in one large bag. The ingredients from the kit was mixed and sold in deli cases at retail stores. The product sold in deli cases has the UPC 2 11565 20216 1.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0696-2018·2018-03-07

    Olympus Recalls Urologic Endoscopic Working Inserts and Bridges Due to Adhesive Fragments

    Olympus is recalling specific urologic endoscopic working inserts and bridges because adhesive fragments may detach and enter patients during procedures.

    Product
    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18726·2018-03-07

    Husqvarna Recalls FS 450 Competition Motorcycles Due to Brake Failure Hazard

    Husqvarna is recalling approximately 160 FS 450 closed course competition motorcycles from model years 2016 to 2018 because a cracked front brake piston can cause brake failure and crashes.

    Product
    Husqvarna FS 450 closed course competition motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0836-2018·2018-03-07

    M&P Food Productions Recalls Vareniki Cabbage for Undeclared Wheat

    M&P Food Productions is recalling Vareniki Cabbage because the product contains undeclared wheat. Consumers with celiac disease or wheat allergies should not eat the product.

    Product
    M&P Food Productions brand Vareniki Cabbage, Net WT 14 oz. (396g), Keep Frozen, UPC: 7 07163 02619 8
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0813-2018·2018-03-07

    Alto Development Corp Recalls Surgical Punches Due to Packaging Damage

    Alto Development Corp is recalling surgical punches because packaging damage during transport may have compromised sterility.

    Product
    Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0823-2018·2018-03-07

    LifeCell Revolve Advanced Adipose System Recalled for Bacterial Endotoxins

    LifeCell is recalling 25,798 units of the Revolve Advanced Adipose System due to bacterial endotoxin levels above acceptable limits.

    Product
    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2018·2018-03-07

    Oakworks Medical Imaging Table Foot Controls Recalled for Lodging Hazard

    Oakworks Inc. is recalling foot controls for specific medical imaging tables because they can become lodged under the table base or column.

    Product
    Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table OAKWOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2018·2018-03-07

    AngioDynamics Recalls Soft-Vu Omni Flush Angiographic Catheters

    AngioDynamics is recalling 28 Soft-Vu Omni Flush Angiographic Catheters because they were distributed before required post-sterilization release activities were completed.

    Product
    Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0699-2018·2018-03-07

    Moog Curlin Infusion Administration Set Recalled Due to Particulate Matter

    Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets because particulate matter was found on the spike.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2018·2018-03-07

    Avid Medical Recalls TruCustom NEURO Kits Due to Foreign Material

    Avid Medical is recalling 46 TruCustom NEURO PK convenience kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0693-2018·2018-03-07

    Ethicon Recalls VICRYL RAPIDE Suture Lots Due to Tensile Failure

    Ethicon is recalling 25 lots of VICRYL RAPIDE suture because the material failed knot tensile strength testing during quality control.

    Product
    Coated VICRYL RAPIDETM (Polyglactin 910) Suture
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0840-2018·2018-03-07

    M&P Food Productions Vareniki Recalled for Undeclared Wheat

    M&P Food Productions is recalling Vareniki - farmer cheese due to undeclared wheat. Consumers with celiac disease or wheat allergies should not consume the product.

    Product
    M&P Food Productions brand Vareniki - farmer cheese, Hand made, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0716 302618 1
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0828-2018·2018-03-07

    Stryker Berchtold Chromophare Surgical Light Recall for Missing Parts

    Stryker is recalling 1,162 Berchtold Chromophare surgical lights because missing parts could cause the equipment to fall.

    Product
    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating dise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2018·2018-03-07

    Accord Media Recalls Ultra Renew Devices for Unapproved LED Light

    Accord Media, LLC is recalling 524 Ultra Renew devices distributed nationwide because they use an unapproved green LED light to treat hyperpigmentation.

    Product
    Ultra Renew
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2018·2018-03-07

    Philips Recalls Allura Xper Systems Due to Anode Drive Unit Failure

    Philips is recalling 705 Allura Xper systems because Anode Drive Units may fail in high-voltage regions, reducing X-ray performance to emergency mode.

    Product
    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2018·2018-03-07

    Moog Curlin Infusion Sets Recalled for Particulate Matter on Spike

    Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets because particulate matter was found on the spike. The recall covers 7,979 cases distributed nationwide and internationally.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Admini
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2018·2018-03-07

    Avid Medical Recalls TruCustom Upper Extremity Kits Due to Foreign Material

    Avid Medical is recalling 216 TruCustom Upper Extremity convenience kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0794-2018·2018-03-07

    Avid Medical Recalls TruCustom Kits With Foreign Material in Needles

    Avid Medical is recalling 44 TruCustom Minor Procedure kits because the included needles may contain loose polypropylene foreign material.

    Product
    AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0773-2018·2018-03-07

    Zimmer Biomet Recalls Phoenix Antegrade Femoral Nail Connecting Bolts

    Zimmer Biomet is recalling 337 Phoenix Antegrade Femoral Nail Connecting Bolts because the bolt may fracture during insertion of the femoral nail.

    Product
    Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2018·2018-03-07

    Siemens Axiom Artis Medical Devices Recalled for Liquid Entry Risk

    Siemens Medical Solutions is recalling Axiom Artis devices due to a potential for liquid entry.

    Product
    Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0867-2018·2018-03-07

    Kanan Enterprises Recalls Unsalted Almonds Due to Undeclared Allergens

    Kanan Enterprises is recalling Southern Grove Unsalted Almonds because some bags contained Wasabi Soy Almonds, which include undeclared wheat, soy, and peanut oil.

    Product
    SOUTHERN GROVE ALMONDS Unsalted 14 oz (397g) pouch bag INGREDIENTS: ALMONDS. Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 24647 1
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0812-2018·2018-03-07

    ZOLL 731 Series Ventilators Recalled for Software Anomaly

    ZOLL Medical Corporation is recalling 46 units of 731 Series Ventilators due to a software anomaly that may allow users to inadvertently change device settings.

    Product
    731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous pos
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0777-2018·2018-03-07

    3M Surgical Clipper Professional 9681 Recalled for Battery Degradation Risk

    3M is recalling 120,000 Surgical Clipper Professional 9681 units worldwide due to lithium-ion battery degradation risks, including excessive heat and potential venting.

    Product
    3M Surgical Clipper Professional 9681
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2018·2018-03-07

    Cook Inc. Recalls Percutaneous Gastrostomy Sets Due to Wire Guide Defect

    Cook Inc. is recalling 615 units of Mallinckrodt Institute Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V157000·2018-03-07

    Thomas Built Buses Minotour Recalled for Wheelchair Lift Safety Defect

    Daimler Trucks North America is recalling 2007-2018 Thomas Built Buses Minotour school buses because the wheelchair lift may operate while the vehicle is in motion.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2018·2018-03-07

    Aesculap proSA Tool Set Recalled for Incorrect Valve Pressure Adjustment

    Aesculap Implant Systems LLC is recalling proSA Tool Sets because the adjusting pin does not set the correct valve opening pressure for the shunt system.

    Product
    proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0811-2018·2018-03-07

    NxStage Dialysate Sacks Recalled for Exceeding Endotoxin Quality Standards

    NxStage Medical is recalling dialysate sacks because endotoxin levels may exceed the ANSI/AAMI quality standard of 0.5 EU/ml.

    Product
    NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2018·2018-03-07

    Cosmedent Etching Gel Recalled Due to Syringe Tip Detachment Risk

    Cosmedent, Inc. is recalling 84 units of Etching Gel because the syringe tips may detach during use.

    Product
    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0694-2018·2018-03-07

    Integra CUSA Clarity Footswitch Recalled for Unintended Activation

    Integra LifeSciences is recalling 155 CUSA Clarity footswitches because a defect may cause unintended ultrasonic fragmentation activation during surgery.

    Product
    Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18117·2018-03-07

    Topson Downs Recalls Cat & Jack Girls' Jeans Due to Laceration Hazard

    Topson Downs is recalling Cat & Jack Girls' Star Studded Skinny Jeans because metal stars can detach and cause lacerations. Consumers should stop wearing them and return them to Target for a refund.

    Product
    Cat & Jack Girls' Star Studded Skinny Jeans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2018·2018-03-07

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Sterile Barrier Risk

    Zimmer Biomet is recalling 38,069 units of Versys 6 inch Beaded Full Coat Plus Hip Prostheses because weight issues may have compromised the sterile barrier.

    Product
    Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2018·2018-03-07

    Avid Medical Recalls TruCustom Laminectomy Kits Due to Foreign Material

    Avid Medical is recalling 12 TruCustom Laminectomy Kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0832-2018·2018-03-07

    Sumano's Bakery Recalls Sourdough French Bread Due to Metal Contamination

    Sumano's Bakery is recalling Sourdough French bread after a customer found a small metal piece on the outside of the loaf before baking.

    Product
    Sourdough French: Product number 2044; SKU 61659799; GTIN [00046567600932] ; UPC 831 49000044 20 pieces; Ingredients: Unbleached Wheat Flour, Water, Sea Salt, Starter (Fermented dough). Best Practices: 1. Keep Bread frozen at all times 2. Pull bread out of freezer 3
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0701-2018·2018-03-07

    Moog Curlin Infusion Administration Set Recalled for Particulate Matter

    Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets due to particulate matter found on the spike.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2018·2018-03-07

    Siemens Medical Solutions Recalls Artis zee and Artis zeego Foot Switches

    Siemens Medical Solutions is recalling 510 foot switch accessories for Artis zee and Artis zeego x-ray systems because they may fail to release radiation.

    Product
    Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states

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