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.

33576–33600 of 50502

  • HighFDA (Food)·F-0782-2017·2016-12-28

    Wakefern Recalls Oatmeal Raisin Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling 24-count oatmeal raisin cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24CT Oatmeal Raisin Cookies Net Wt. 24oz UPC 208710004190
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0826-2017·2016-12-28

    Northern Fish Products Recalls Hot Smoked Salmon Due to Undeclared Soy

    Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout because they contain undeclared soy.

    Product
    PREMIUM SMOKED SALMON UPC 7 02772 00564 0 Packaged in a 5 lb case 20/4oz vacuum packaged per case. Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0618-2017·2016-12-28

    Whole Foods 365 Croissants Recalled for Undeclared Eggs

    Whole Foods Market Brand 365 croissants are being recalled because they contain undeclared eggs, posing a risk to individuals with egg allergies.

    Product
    CROISSANT 6 PK
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0810-2017·2016-12-28

    Brownwood Farms Recalls Yankee Bourbon BBQ Sauce for Undeclared Soy

    Brownwood Farms is recalling Yankee Bourbon BBQ Sauce because it contains soy ingredients not declared on the label.

    Product
    Brownwood Farms Yankee Bourbon BBQ Sauce. 19oz glass bottles and 1 gallon
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2017·2016-12-28

    Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Electric Shock Risk

    Accuray is recalling 115 CyberKnife Robotic Radiosurgery Systems (models G3, G4, VSI) due to a potential electric shock hazard during maintenance.

    Product
    CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the…
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0776-2017·2016-12-28

    AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk

    AngioDynamics is recalling 145 boxes of Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2017·2016-12-28

    Amendia Recalls Optimus Fixed Awl Due to Tip Breakage During Surgery

    Amendia, Inc. is recalling nine Optimus Fixed Awl devices because the tip broke after impaction during surgery. The devices were distributed to Florida, Georgia, Illinois, Missouri, and Texas.

    Product
    Optimus Fixed Awl
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0898-2017·2016-12-28

    Teleflex Recalls Mucosal Atomization Devices Due to Incomplete Atomization

    Teleflex Medical is recalling Mucosal Atomization Devices because they may produce a straight stream instead of a fully atomized plume of medication.

    Product
    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0792-2017·2016-12-28

    Crescent Vending Recalls Egg Salad Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 13 egg salad sandwiches for failing to declare wheat, soy, and milk allergens.

    Product
    Egg Salad on Wheat wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil) and eggs
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0806-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 16 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 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-0831-2017·2016-12-28

    Northern Fish Products Recalls Smoked Fish Due to Undeclared Soy

    Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout because they contain undeclared soy.

    Product
    Smoked Trout Rainbow Trout, NORTHERN FISH PRODUCTS, INC.***" Packaged in bulk 10lb case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0821-2017·2016-12-28

    Northern Fish Products Recalls Smoked Salmon for Undeclared Soy

    Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout due to undeclared soy. The recall excludes hot jerky salmon and jerky salmon.

    Product
    "***NORTHERN CLASSICS NATURAL SMOKED SALMON. Net WT. is filled in on a separate white label. Product is frozen and vacuum packed. Product also referred to as SALMON HOT SMKD SIDE ATL SK-ON.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0769-2017·2016-12-28

    Wakefern Recalls Gourmet Variety Pack Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling specific varieties of Gourmet Variety Pack Cookies because they may contain metal pieces.

    Product
    12 Gourmet Variety Pack Cookies - Net Wt. 15 oz UPC 289786003997 Gourmet Variety Pack Cookies Net Wt. 30 oz UPC 289772006995
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·16V938000·2016-12-28

    Navistar Recalls 2017 International Trucks Due to Battery Latch Fire Risk

    Navistar is recalling 2017 International ProStar, LoneStar, 9900i, and TranStar trucks because a battery latch may cause an electrical short and fire.

    Product
    INTERNATIONAL — INTERNATIONAL PROSTAR, LONESTAR, TRANSTAR, 9900I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0824-2017·2016-12-28

    Northern Fish Products Recalls Hot Smoked Fish for Undeclared Soy

    Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout due to undeclared soy.

    Product
    ***NORTHERN CLASSICS FINEST QUALITY KIPPERED SALMON CHUNKLETS. This package can be combined with other products and placed into a combination package. Each package is individually labeled. Bulk cases contain 5 lbs.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0945-2017·2016-12-28

    Streit's Quinoa with Mushrooms Recalled for Undeclared Sulfites

    Aron Streit Inc is recalling Streit's Quinoa with Mushrooms & Herbs due to the presence of undeclared sulfites.

    Product
    Streit's Quinoa with Mushrooms & Herbs, Net Wt. 7.7 oz (220g). Product of Israel
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0811-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Fragmentation

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

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 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-0899-2017·2016-12-28

    Radiometer AQURE System Software Recalled for Patient View Display Error

    Radiometer America Inc is recalling AQURE System software due to a design error that may cause users to misread patient parameters and values.

    Product
    AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0818-2017·2016-12-28

    Fairway Candy Corn Recalled for Undeclared Egg Allergen

    Fairway Market is recalling Candy Corn for potentially containing undeclared egg. The product was sold in New York, New Jersey, Connecticut, and online.

    Product
    FAIRWAY LIKE NO OTHER MARKET brand CANDY CORN, of varying weight, Item Code 228402 XXXXXX -- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. --- PACKAGED BY FAIRWAY MARKET 2284 12TH AVE., NEW YORK, NY 10027
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0765-2017·2016-12-28

    Preferred Meals Cavatappi Pasta Recalled for Possible Listeria Contamination

    Preferred Meal Systems, Inc. is recalling 95,364 units of Cavatappi Pasta with Mascarpone Tomato Cream Sauce due to possible Listeria monocytogenes contamination.

    Product
    Preferred Meals, Cook and Serve, Cavatappi Pasta with Mascarpone Tomato Cream Sauce; 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0797-2017·2016-12-28

    Oscor Medical Device Recall for Sheath Liner Fragmentation

    Oscor, Inc. is recalling 11 Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 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-0795-2017·2016-12-28

    Crescent Vending Turkey Sandwiches Recalled for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 8 oz. Turkey, Bacon and Swiss on Macaroni Salad sandwiches due to undeclared wheat, soy, and milk allergens.

    Product
    Turkey, Bacon and Swiss on Macaroni Salad wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0797-2017·2016-12-28

    Crescent Vending Recalls Roast Beef and Cheddar Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 11 roast beef and cheddar cheese sandwiches on Kaiser rolls due to undeclared wheat, soy, and milk allergens.

    Product
    Roast Beef and Cheddar Cheese on Kaiser Roll wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk
    Category
    Food
    Distribution
    0 states