The Recall Desk

Archive

November 2018 recalls

846 recalls were announced in November 2018.

What the numbers show

Critical
142
Severe
282
High
270
Moderate
123
Low
29

Of the 846 recalls this month scored against our rubric, 17% are Critical, 33% are Severe.

Which agencies issued them

801–846 of 846

  • ModerateFDA (Devices)·Z-0282-2019·2018-11-07

    Arrow Multi-Lumen CVC Kit Recalled for Expired Product Documentation Error

    Arrow International Inc. is recalling 105 units of Arrow AGB + Multi-Lumen CVC Kits because shipping documentation listed an incorrect expiration date, though the product lidstock is correct.

    Product
    Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0324-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0362-2019·2018-11-07

    Fresenius Kabi Recalls Volumat MC Agilia Infusion Pumps for Software Upgrade

    Fresenius Kabi is recalling 7,082 Volumat MC Agilia Volumetric Infusion Pumps to install a mandatory software upgrade that prevents common software malfunctions.

    Product
    Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0116-2019·2018-11-07

    Sprayology Recalls Party Relief Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 2,956 bottles of Party Relief Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.

    Product
    Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0344-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0342-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0330-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2019·2018-11-07

    Zilver 518 Biliary Stent recall issued due to incorrect instruction for use details

    The FDA is recalling the Zilver 518 Biliary Stent because its instruction for use details were incorrect, requiring updated deployment guidance.

    Product
    Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0115-2019·2018-11-07

    Sprayology Recalls TravelEase Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 1,307 bottles of TravelEase Homeopathic Oral Spray nationwide due to manufacturing deviations that could result in microbial contamination.

    Product
    TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0340-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0120-2019·2018-11-07

    Sprayology Recalls PMS Support Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 647 bottles of PMS Support Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.

    Product
    PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0343-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0284-2019·2018-11-07

    Acumedia Campylobacter Medium Recalled for Incorrect Expiration Date

    Acumedia Manufacturers is recalling 93 bottles of Campylobacter Blood Free Selective Medium due to incorrect expiration dates.

    Product
    Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0350-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0355-2019·2018-11-07

    Beckman Coulter Recalls Sorting-Drive Software Due to Barcode Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because the manual barcode printing function may generate incorrect IDs for sample tubes.

    Product
    Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0358-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recalled for Barcode Label Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect tube label IDs.

    Product
    Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0349-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0368-2019·2018-11-07

    3M Fast Release Varnish Recalled for Unpleasant Flavor

    3M is recalling 73 units of Fast Release Varnish due to a manufacturing error that introduced extraneous material, causing an unpleasant flavor.

    Product
    3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0329-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0323-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0283-2019·2018-11-07

    Acumedia Palcam Agar Base Recalled for Incorrect Expiration Date Labeling

    Acumedia Manufacturers, Inc. is recalling 22 bottles of Palcam Agar Base because the expiration date on the label is incorrect.

    Product
    Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0337-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0321-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0359-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recall for Barcode Printing Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect IDs for tube labels.

    Product
    Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0354-2019·2018-11-07

    Beckman Coulter Sorting-Drive 4.2 Software Recalled for Barcode Errors

    Beckman Coulter is recalling 25 units of Sorting-Drive 4.2 software due to a defect that may generate incorrect barcode IDs when printing consecutively numbered tube labels.

    Product
    Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V783000·2018-11-06

    Blue Bird Recalls 2017-2019 Vision School Buses Due to Fire Risk

    Blue Bird is recalling 2017-2019 Vision school buses because alternator cables may chafe, causing an electrical short and increasing the risk of a fire.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V781000·2018-11-06

    Lotus Recalls 2018 Evora Vehicles for Steering Column Assembly Error

    Lotus is recalling 2018 Evora vehicles because an assembly error may prevent the steering column from collapsing properly in a frontal collision, increasing injury risk.

    Product
    LOTUS — LOTUS EVORA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·109-2018·2018-11-06

    Ganaderos Borges Recalls Pork Patties Due to Metal Contamination

    Ganaderos Borges is recalling approximately 14,760 pounds of raw pork patties that may contain metal. The products were distributed to institutional locations in Puerto Rico.

    Product
    Ganaderos Borges — Ganaderos Borges, Inc. Recalls Pork Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V785000·2018-11-06

    Keystone Montana Recalled for Potential Brake Fastener Failure

    Keystone is recalling 2019 Montana recreational trailers with the Legacy package because brake fasteners may fail, causing loss of braking ability.

    Product
    KEYSTONE — KEYSTONE MONTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V780000·2018-11-05

    Thor Aria and Venetian Motorhomes Recalled for Brake Caliper Bolts

    Thor Motor Coach is recalling 2018-2019 Aria and Venetian motorhomes because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR VENETIAN, ARIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V779000·2018-11-02

    Triple E Recalls 2019 Unity Motorhomes Due to Brake Line Contact

    Triple E is recalling 2019 Unity motorhomes because a support bracket may contact the brake line, causing fluid leaks and reduced braking ability.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V774000·2018-11-01

    GM Recalls 2019 Vehicles Due to Air Bag Module Defect

    General Motors is recalling 2019 Buick Encore, Chevrolet Spark, Traverse, and Trax vehicles because the air bag module may not be programmed correctly, preventing deployment in a crash.

    Product
    CHEVROLET — CHEVROLET, BUICK SPARK, TRAX, TRAVERSE, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V775000·2018-11-01

    Ford Recalls 2010-2012 Vehicles for Passenger Air Bag Defect

    Ford is recalling specific 2010-2012 vehicles to replace passenger air bag modules that may fail to inflate properly in a crash.

    Product
    LINCOLN — LINCOLN, MERCURY, FORD MKZ, MILAN, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V777000·2018-11-01

    Honda and Acura Recall Vehicles for Rear Brake Caliper Coating Defect

    Honda is recalling specific 2016-2019 HR-V, Odyssey, and Acura MDX models because rear brake caliper pistons may have insufficient coating, reducing braking performance.

    Product
    HONDA — HONDA, ACURA HR-V, ODYSSEY, MDX, MDX SPORT HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V778000·2018-11-01

    Mack Recalls 2019 Trucks Due to Potential Steering Shaft Separation

    Mack Trucks is recalling 2019 Anthem, Granite, and Pinnacle vehicles because a loose pinch bolt may allow the steering shaft to separate, causing loss of steering.

    Product
    MACK — MACK PINNACLE (PI/PN), ANTHEM (AN), GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V773000·2018-11-01

    Subaru Recalls 2018 Legacy and Outback for Fuel Display Software Error

    Subaru is recalling 2018 Legacy and Outback vehicles because a software error may cause the fuel gauge to display incorrect levels, increasing the risk of stalling and a crash.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V772000·2018-11-01

    Subaru and Scion Recall Issued for Engine Valve Spring Fracture Risk

    Subaru and Toyota are recalling specific 2012-2014 Impreza, BRZ, XV Crosstrek, and FR-S models because engine valve springs may fracture, potentially causing an engine stall that increases crash risk.

    Product
    SCION — SCION, SUBARU FR-S, BRZ, XV CROSSTREK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19027·2018-11-01

    Black & Decker Recalls Hammer Drills Due to Side Handle Injury Hazard

    Black & Decker is recalling specific hammer drills and drill drivers because the side handles can slip or break, posing an injury risk.

    Product
    Black & Decker, Bostitch and Porter-Cable Hammer Drills and Drill Drivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19712·2018-11-01

    Pain Relief Naturally Recalls Lidocaine Products for Child-Resistant Closure Failure

    Pain Relief Naturally is recalling lidocaine creams, sprays, and gels because the packaging failed to meet child-resistant closure requirements, posing a poisoning risk to young children.

    Product
    Numbify, Extra Strength Numbify, Pre-TAT Tattoo, Superior Pain & Itch Relief & Soothing Sore Relief creams, sprays and gels
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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