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.

32101–32125 of 50502

  • HighFDA (Devices)·Z-2229-2017·2017-06-14

    ConvaTec Recalls Rebreathing Masks with Reservoir Bags and Tubing

    ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.

    Product
    Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2280-2017·2017-06-14

    Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk

    Arrow International is recalling Pressure Injectable PICC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2341-2017·2017-06-14

    Alaska Pasta Company Recalls Gemelli for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated Gemelli pasta because it contains undeclared soy lecithin from cooking spray. The product was distributed only in Alaska.

    Product
    Gemelli. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2294-2017·2017-06-14

    Aunt Jemima Buttermilk 12 Low Fat Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Buttermilk 12 Low Fat Pancakes due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) BUTTERMILK 12 LOW FAT PANCAKES, NET WT14.5oz UPC 019600061007
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2299-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Homestyle Pancakes for Listeria Risk

    Pinnacle Foods is recalling specific Aunt Jemima Homestyle Pancakes due to potential Listeria monocytogenes contamination. Consumers should check their pantry for the affected UPC codes.

    Product
    Homestyle pancakes packaged as follows: a) AUNT JEMIMA(R) 12 HOMESTYLE PANCAKES, NET WT 14.8oz UPC 019600069102 b) AUNT JEMIMA(R) HOMESTYLE PANCAKES, 60 COUNT, NET WT 4.63 LBS, UPC 019600435907 c) AUNT JEMIMA(R) HOMESTYLE PANCAKES,60 COUNT (MEXICO), NET WT 4.29 LBS, UPC…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2017·2017-06-14

    Arrow International Recalls Two-Lumen Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific lots of two-lumen hemodialysis catheterization kits due to a Class II medical device recall.

    Product
    Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2297-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Pancakes for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 12 Pancakes Made with Whole Grain due to potential Listeria monocytogenes contamination. The recall covers 6,955 units distributed nationwide.

    Product
    AUNT JEMIMA(R) 12 PANCAKES MADE WITH WHOLE GRAIN, NET WT 14.5oz UPC 019600066408
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2327-2017·2017-06-14

    Choice Northwest Recalls Paradise Deli Hazelnut Cake for Undeclared Soy

    Choice Northwest is recalling Paradise Deli brand Hazelnut Cake because the product contains undeclared soy lecithin, a major food allergen.

    Product
    Hazelnut Cake, Paradise Deli brand, net wt. 15 oz., UPC 0 31619 10201 4. The label is read in parts: "***Contains: Oregon grown hazelnuts, cane sugar, organic unbleached wheat flour, fresh eggs, sea salt, pure vanilla***PARADISE DELI - PO Box 22411, Eugene, OR 97402 *** 925…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2238-2017·2017-06-14

    ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns

    ConvaTec is voluntarily recalling specific lots of adult non-rebreather oxygen masks. The recall was initiated due to quality concerns, with no specific injuries reported in the source text.

    Product
    Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2344-2017·2017-06-14

    Alaska Pasta Company Recalls Refrigerated Linguine Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling 78.50 lbs of refrigerated linguine distributed in Alaska because the product contains undeclared soy lecithin.

    Product
    Linguine. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2310-2017·2017-06-14

    Pinnacle Foods Recalls Hilltop Hearth French Toast for Listeria Risk

    Pinnacle Foods is recalling Hilltop Hearth and Mrs. Butter-worth's French Toast nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    French toast packaged as follows: a) Hilltop HEARTH, FRENCH TOAST, 18 8 COUNT BAGS, NET WT 10 LB 11.2 OZ, UPC 075810861816 b) Hilltop HEARTH, FRENCH TOAST, 12 6 COUNT BAGS, NET WT 10 LB 11.2 OZ, UPC 075810843855 c) Hilltop HEARTH FRENCH TOAST, 12 6 COUNT BAGS, NET WT. 10 LB…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2304-2017·2017-06-14

    Aunt Jemima Waffles Recalled for Potential Listeria Contamination

    Pinnacle Foods is recalling Aunt Jemima Buttermilk Waffles due to potential Listeria monocytogenes contamination. The recall covers 403,583 units distributed nationwide.

    Product
    AUNT JEMIMA(R) 14 BUTTERMILK WAFFLES, NET WT 17.18oz UPC 019600062103
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2017·2017-06-14

    Alphatec Recalls Arsenal Spinal Fixation System Set Screws

    Alphatec Spine is recalling Arsenal Spinal Fixation System Set Screws due to a trend of postoperative disengagement from the screw body.

    Product
    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2017·2017-06-14

    ConvaTec Recalls Rebreather Oxygen Masks Due to Defect

    ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.

    Product
    Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2306-2017·2017-06-14

    Aunt Jemima Low Fat Waffles Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 14 Low Fat Waffles nationwide due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 14 LOW FAT WAFFLES, NET WT 17.18oz UPC 019600062301
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2017·2017-06-14

    ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks

    ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.

    Product
    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2295-2017·2017-06-14

    Aunt Jemima Blueberry Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 12 Blueberry Pancakes nationwide due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 12 BLUEBERRY PANCAKES, NET WT 14.8oz UPC 019600064701
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2017·2017-06-14

    ConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect

    ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.

    Product
    Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2235-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns

    ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.

    Product
    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2263-2017·2017-06-14

    Arrow Central Venous Catheter Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling 43,394 units of ARROWg+ard Blue PLUS Two-Lumen Central Venous Catheterization Kits due to safety cover disengagement and needlestick injury reports.

    Product
    ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2343-2017·2017-06-14

    Alaska Pasta Company Recalls Spinach Lasagne Sheets for Undeclared Soy

    Alaska Pasta Company is recalling refrigerated spinach lasagne sheets because they contain undeclared soy lecithin from cooking spray.

    Product
    Lasagne Sheets Spinach. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right).…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2293-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Mini Pancakes Due to Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Lil' Griddles Mini pancakes nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) LIL' GRiDDLES(TM) MINI pancakes, 40 COUNT, NET WT 14.5oz UPC 019600054801
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2303-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Waffles Due to Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Homestyle Waffles nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 14 HOMESTYLE WAFFLES, NET WT 17.18oz UPC 019600062004
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2305-2017·2017-06-14

    Aunt Jemima Blueberry Waffles Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 14 Blueberry Waffles due to potential Listeria monocytogenes contamination. The recall covers 153,513 units distributed nationwide.

    Product
    AUNT JEMIMA(R) 14 BLUEBERRY WAFFLES, NET WT 17.18oz UPC 019600062202
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2017·2017-06-14

    Zimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability

    Zimmer CAS is voluntarily recalling 10 Sesamoid Plasty workstations because the top of the unit may fall over during disassembly.

    Product
    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and…
    Category
    Medical Device
    Distribution
    2 states