The Recall Desk

Archive

November 2018 recalls

846 recalls were announced in November 2018.

What the numbers show

Critical
142
Severe
250
High
301
Moderate
124
Low
29

Of the 846 recalls this month scored against our rubric, 17% are Critical, 30% are Severe.

Which agencies issued them

801–846 of 846

  • ModerateFDA (Devices)·Z-0332-2019·2018-11-07

    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 20mm, Catalog Number: ZIB6-125-5.0-20 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-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-0316-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Instruction Error

    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 40mm, Catalog Number: ZIB5-125-4.0-40 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-0333-2019·2018-11-07

    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 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 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-0351-2019·2018-11-07

    Cook Medical Recalls Zilver Biliary Stent Due to Incorrect Removal Instructions

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

    Product
    Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 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
  • ModerateFDA (Devices)·Z-0327-2019·2018-11-07

    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 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 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 (Devices)·Z-0331-2019·2018-11-07

    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 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 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-0334-2019·2018-11-07

    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 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 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
  • ModerateFDA (Food)·F-0073-2019·2018-11-07

    Lone Star Bakery Recalls Spinach and Mushroom Pie for Foreign Object Risk

    Lone Star Bakery is recalling Spinach and Mushroom Pie due to a potential foreign object hazard. The product was distributed in five states.

    Product
    Spinach and Mushroom Pie, Net Wt. 6 OZ, packaged in a paper carton, Keep Frozen
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0352-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,384 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 80mm, Catalog Number: ZIB6-125-14.0-80 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-0322-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

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

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 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
  • ModerateFDA (Devices)·Z-0325-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

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

    Product
    Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 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-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-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
  • 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-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 fa
    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-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-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-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 4.2
    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 Use
    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-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-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-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-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
  • 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·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
  • 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·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 — THOR, THOR MOTOR COACH ARIA, VENETIAN
    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·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
  • 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·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
  • 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
  • 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 OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide

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