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.

33526–33550 of 50502

  • HighFDA (Food)·F-0827-2017·2016-12-28

    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
    Sweet & Spicy Style Atlantic Salmon, Product of USA Packed By Northern Fish Products***" Packaged in bulk 5lb case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0770-2017·2016-12-28

    Wakefern Recalls Salted Caramel Cookies Due to Metal Contamination

    Wakefern Food Corp. is recalling specific 12 and 24-pack salted caramel chocolate chunk cookies because they may contain metal pieces.

    Product
    12 pack Gourmet Salted Caramel Chocolate Chunk Cookies - Net Wt.15 oz. UPC 2897850203992 ;UPC 289785003998
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0815-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Fragment Release

    Oscor, Inc. is recalling 59 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 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 (Food)·F-0828-2017·2016-12-28

    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
    Kippered Salmon Tips Product of USA Packed By Northern Fish Products***" Packaged in bulk 5lb case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0793-2017·2016-12-28

    Crescent Vending Cheeseburgers Recalled for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 5 oz. cheeseburgers for failing to declare wheat, soy, and milk allergens.

    Product
    Cheeseburger wrapped in clear film, 5 oz. Undeclared Allergens - Wheat, Soy (Lecithin, oil, flour), Milk,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0885-2017·2016-12-28

    Siemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 PSA assays because they do not meet the High-dose Hook Effect expectations stated in the Instructions for Use.

    Product
    IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0794-2017·2016-12-28

    Crescent Vending Recalls Hot Sausage Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 6 oz. Hot Sausage on Club sandwiches because they contain undeclared wheat, soy, and milk.

    Product
    Hot Sausage on Club wrapped in clear film, 6 oz. Undeclared allergens - Wheat, Soy (oil)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0791-2017·2016-12-28

    Oscor Medical Sheath Recalled for Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 87 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 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-0801-2017·2016-12-28

    Crescent Vending Recalls Hoagies for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 25 Regular Hoagies on Italian Rolls because they contain undeclared wheat, soy, and milk.

    Product
    Regular Hoagie on Italian Roll, wrapped in clear film, 7 oz. Undeclared allergens - Wheat, Soy (oil), Milk
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0764-2017·2016-12-28

    Preferred Meals Tortellini Recalled for Possible Listeria Contamination

    Preferred Meal Systems is recalling Creamy Red Pepper Sauce and Cheese Tortellini due to possible Listeria monocytogenes contamination.

    Product
    Preferred Meals, Cook and Serve, Creamy Red Pepper Sauce and Cheese Tortellini with Parmesan Cheese, 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0775-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

    AngioDynamics is recalling 996 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 124 units of the Adelante Breezeway 10F sheath because a fragment of the inner liner detached during insertion. The product was distributed worldwide.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 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-0817-2017·2016-12-28

    Oscor Recalls Medtronic Arrive Braided Transseptal Sheaths Due to Liner Fragmentation

    Oscor, Inc. is recalling 991 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¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 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 (Food)·F-0829-2017·2016-12-28

    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
    Brown Sugar Style Smoked Black Cod Black Cod, **Product of USA Packed By Northern Fish Products***" Packaged in bulk 5lb case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0808-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 33 units of the Adelante Breezway 10F Straight sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 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-0777-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

    AngioDynamics is recalling 7 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach from the hub during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0825-2017·2016-12-28

    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 the products contain undeclared soy.

    Product
    PREMIUM SMOKED SALMON***CAJUN***NET WT: 4OZ***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. UPC 7 02772 00562 6.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0619-2017·2016-12-28

    Whole Foods 365 Multi Grain Croissant Recalled for Undeclared Eggs

    Whole Foods Market Brand 365 is recalling Multi Grain Croissant 6 PK products due to undeclared eggs. The recall affects select stores in seven states and Washington D.C.

    Product
    MULTI GRAIN CROISSANT 6 PK
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0803-2017·2016-12-28

    Crescent Vending Recalls Bacon Egg and Cheese Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 13 bacon, egg, and cheese sandwiches on Kaiser rolls because they contain undeclared wheat, soy, and milk.

    Product
    Bacon Egg and Cheese on Kaiser Roll wrapped in clear film, 5 oz. Undeclared allergen - Wheat, Soy (oil, lecithin), Milk, Egg
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0798-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.

    Product
    OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 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-0814-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

    Oscor, Inc. is recalling 186 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner was found during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 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 (Food)·F-0823-2017·2016-12-28

    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.

    Product
    WILD CATCH PREMIUM SMOKED SALMON***NATURAL***NET WT: 4OZ*** UPC 7 02772 00559 6. 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