The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

33601–33625 of 50502

  • HighFDA (Devices)·Z-0803-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 74 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The device is used to introduce catheters to heart chambers.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0796-2017·2016-12-28

    Crescent Vending Recalls Imported Ham Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 13 imported ham sandwiches with potato salad due to undeclared wheat, soy, and milk allergens.

    Product
    Imported Ham with Potato salad wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil), Milk, Egg
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0753-2017·2016-12-28

    Real Fudge Recalls White Fudge Oreo for Undeclared Wheat and Blue 1

    Real Fudge is recalling White Fudge Oreo products due to undeclared wheat and Blue 1 dye. The recall affects 8 oz. and 16 oz. containers distributed in five states.

    Product
    White Fudge Oreo, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz. and 16 oz.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0784-2017·2016-12-28

    Ultroid Procedure Pack Recalled for Quality System Non-Compliance

    Ultroid Technologies is recalling 52,084 procedure packs because they were not manufactured under required quality system controls.

    Product
    Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0877-2017·2016-12-28

    BD SurePath Collection Vials Recalled Due to Cracked Caps

    Becton Dickinson is recalling SurePath collection vials because cracked caps may allow preservative fluid to leak.

    Product
    BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2017·2016-12-28

    AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk

    AngioDynamics is recalling 751 Stiffened Micro-Introducer Kits because a component may detach during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 991 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0799-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 21 units of the Adelante Breezway 8F Straight sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0781-2017·2016-12-28

    Wakefern Recalls Party Candy Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling 24-count Take&Bake Party Candy Cookies because they may contain metal pieces.

    Product
    24CT Take&Bake Party Candy Cookies Net Wt. 24oz UPC 208902004199
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0870-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0943-2017·2016-12-28

    Interbake Foods Recalls Benton's Peanut Butter Cookies Due to Aflatoxin

    Interbake Foods is recalling Benton's Peanut Butter filled Cookies covered in Rich Fudge because a single lot of peanut butter contained elevated aflatoxin levels.

    Product
    Benton's Peanut Butter filled Cookies covered in Rich Fudge, NET WT 9.5 OZ (269 g), UPC 041 498 1896 55, Distributed by ALDI INC. Great Value, Fudge Covered Peanut Butter, 269 g, Imported for Wal-Mart Canada Corp, Product of USA, UPC 6 28915 24342 0.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0812-2017·2016-12-28

    Brownwood Farms Recalls BBQ Mustard Glaze for Undeclared Soy

    Brownwood Farms is recalling BBQ Mustard Glaze because it contains soy ingredients not declared on the label.

    Product
    Brownwood Farms BBQ Mustard Glaze. 11oz glass bottles and 1 gallon. Private labels: Kimmel Orchard & Vineyard (Barbeque Mustard 11oz)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2017·2016-12-28

    Nuvectra Recalls Algovita Spinal Cord Stimulation Leads Due to Stylet Protrusion

    Nuvectra is recalling Algovita Spinal Cord Stimulation System percutaneous leads because the stylet may protrude beyond the distal lead tip.

    Product
    Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0763-2017·2016-12-28

    Fresh Express Caesar Salad Kits Recalled for Undeclared Walnuts

    Fresh Express is recalling Caesar salad kits because the condiment packets contain undeclared walnuts, a tree nut allergen.

    Product
    Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550 S. Caldwell St. Charlotte, NC 28202, packed in clear flexible plastic bags. Product Code: G163B13A
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0886-2017·2016-12-28

    Amendia Recalls Black Widow Spinal Plates Due to Mating Feature Defect

    Amendia, Inc. is recalling 48 units of Black Widow Buttress Plates due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

    Oscor, Inc. is recalling 215 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0812-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

    Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because an inner liner fragment was found during insertion. The recall covers 1,729 units distributed worldwide.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighNHTSA·16V935000·2016-12-27

    Mercedes-Benz Metris Recall: Passenger Air Bag May Not Vent Properly

    Daimler Vans USA is recalling 2017 Mercedes-Benz Metris vans because the front passenger air bag may not vent properly in a crash, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V932000·2016-12-27

    Honda Recalls 2016 Odyssey for Second Row Seat Slide Defect

    Honda is recalling 2016 Odyssey vehicles because the second row center seat may slide unexpectedly. This defect increases the risk of injury in a crash.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V933000·2016-12-27

    Honda Recalls 2011-2016 Odyssey Vehicles Due to Second Row Seat Defect

    Honda is recalling 2011-2016 Odyssey vehicles because the second row outboard seat release lever may remain unlocked, allowing the seat to move unexpectedly during a crash.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V934000·2016-12-27

    HME Type-6 Wildland Trucks Recalled for Incorrect Weight Rating Label

    HME is recalling 2015-2016 Type-6 Wildland trucks because the certification label may list an incorrect Gross Vehicle Weight Rating, potentially leading to vehicle overload.

    Product
    HME — HME TYPE-6 WILDLAND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V930000·2016-12-23

    KME Recalls Fire Trucks Due to Ladder Position Sensor Defect

    Kovatch Mobile Equipment Corp. is recalling certain KME fire trucks because water may leak into the ladder position sensor, increasing the risk of injury.

    Product
    KME — KME PREDATOR SS AERIAL, PREDATOR AERIAL, PREDATOR PANTHER AERIAL, PREDATOR TDA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V950000·2016-12-23

    ARBOC Spirit of Liberty Buses Recalled for Parking Brake Defect

    ARBOC is recalling 2015-2016 Spirit of Liberty transit buses because the parking brake may engage unexpectedly while driving, increasing crash risk.

    Product
    ARBOC — ARBOC SPIRIT OF LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17059·2016-12-22

    4 Sizzle Recalls Promotional Charcoal Grills Due to Fire Hazard

    4 Sizzle LLC is recalling approximately 1,700 wooden barrel-shaped charcoal grills with the Shock Top logo due to a fire hazard. The grills were distributed as promotional items and display enhancers.

    Product
    Charcoal grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide