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.

32051–32075 of 50502

  • HighFDA (Devices)·Z-2317-2017·2017-06-14

    DePuy Synthes Orthopedic Instruments Recalled for Quality System Violations

    DePuy Orthopaedics is recalling 345 orthopedic instruments modified by U.S. distributors because they were made outside quality system regulations, potentially compromising safety and effectiveness.

    Product
    DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2348-2017·2017-06-14

    Alaska Pasta Company Recalls Frozen Ravioli Cheese Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling frozen Ravioli Cheese because it contains undeclared soy lecithin from canola oil cooking spray. The product was distributed in Alaska.

    Product
    Ravioli Cheese. Product is frozen. 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 (Devices)·Z-2271-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2326-2017·2017-06-14

    Trophy Nut Co. Recalls Honey Bourbon Pecans for Undeclared Allergens

    Trophy Nut Co. is recalling 20 lb. cases of Honey Bourbon Pecans because the product contains undeclared allergens. The product was distributed to one manufacturer in Michigan.

    Product
    Honey Bourbon Pecans Net Wt. 20 lb. (9.088g) Mfg. By: Trophy Nut Co. Tipp City, OH 45371
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2342-2017·2017-06-14

    Alaska Pasta Company Recalls Lasagne Sheets Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated lasagne sheets because they contain undeclared soy lecithin from cooking spray. The product was distributed only in Alaska.

    Product
    Lasagne Sheets. 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-2307-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Mini Pancakes for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Mini Pancakes due to a potential for Listeria monocytogenes contamination. The recall covers 8,344 units distributed nationwide.

    Product
    AUNT JEMIMA(R) MiNi pancakes, MAPLE BLAST, NET WT 3.2 OZ, UPC 001960043563
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2345-2017·2017-06-14

    Alaska Pasta Company Recalls Refrigerated Pappardelli for Undeclared Soy Lecithin

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

    Product
    Papperdelli ¿ inch. 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 (Devices)·Z-2232-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Defect

    ConvaTec is voluntarily recalling elongated oxygen masks in the US and 27 other countries. The recall was initiated by the firm and is classified as FDA Class II.

    Product
    Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2318-2017·2017-06-14

    Zimmer Biomet Recalls Vitality Spinal Fixation System Drivers

    Zimmer Biomet is recalling Vitality T27 Final Drivers and Torque Limiting Handles because they may create torsional springs that damage the device or cause torque values to go out of specification.

    Product
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2346-2017·2017-06-14

    Alaska Pasta Company Recalls Penne for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated penne pasta distributed in Alaska because it contains undeclared soy lecithin from cooking spray.

    Product
    Penne. 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-2347-2017·2017-06-14

    Alaska Pasta Company Recalls Ravioli Butternut for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated Ravioli Butternut because it contains undeclared soy lecithin. The product was distributed only in Alaska.

    Product
    Ravioli Butternut. 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 (Devices)·Z-2298-2017·2017-06-14

    Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk

    Arrow International is recalling QuickFlash Radial Artery Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2350-2017·2017-06-14

    Alaska Pasta Company Recalls Mushroom Ravioli for Undeclared Soy Lecithin

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

    Product
    Ravioli Mushroom. 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 (Devices)·Z-2294-2017·2017-06-14

    Arrow International Recalls Femoral Arterial Line Catheterization Kits

    Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2292-2017·2017-06-14

    Aunt Jemima Blueberry Mini Pancakes Recalled for Listeria Risk

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

    Product
    AUNT JEMIMA(R) LIL' GRIDDLES(TM) BLUEBERRY MINI PANCAKES, 40 COUNT, NET WT 14.5oz UPC 019600054603
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2017·2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling specific Central Venous Access Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2318-2017·2017-06-14

    Pinnacle Foods Recalls Mrs. Butter-worth's Original Pancakes for Listeria Risk

    Pinnacle Foods is recalling Mrs. Butter-worth's Original Pancakes due to potential Listeria monocytogenes contamination. The recall covers 243,669 units distributed nationwide.

    Product
    Mrs. Butter-worth's(R) ORIGINAL PANCAKES, 144 COUNT, NET WT 10.6 LBS, UPC 001960046004
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Injury Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse needles have a safety cover disengagement defect that poses a needlestick injury risk.

    Product
    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2355-2017·2017-06-14

    Alaska Pasta Company Recalls Spaghettoni Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling 69.70 lbs of refrigerated Spaghettoni because it contains undeclared soy lecithin from cooking spray.

    Product
    Spaghettoni. 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 (Devices)·Z-2231-2017·2017-06-14

    ConvaTec Recalls Adult High Concentration Non-Rebreather Oxygen Masks

    ConvaTec, Inc. is voluntarily recalling specific lots of Adult High Concentration Non-Rebreather Oxygen Masks due to a Class II defect.

    Product
    Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2245-2017·2017-06-14

    ConvaTec Recalls Pediatric High Concentration Non-Rebreather Oxygen Tubing

    ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen tubing due to a Class II defect. The recall covers units distributed across the US and multiple international countries.

    Product
    Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2349-2017·2017-06-14

    Alaska Pasta Company Recalls Ravioli Lobster Due to Undeclared Soy Lecithin

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

    Product
    Ravioli Lobster. 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 (Devices)·Z-2240-2017·2017-06-14

    ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Valve Defect

    ConvaTec is recalling specific lots of pediatric oxygen masks because the check valve may not function correctly, potentially affecting oxygen delivery.

    Product
    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2296-2017·2017-06-14

    Aunt Jemima Oatmeal Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Oatmeal Pancakes due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 12 OATMEAL PANCAKES, NET WT 14.8oz UPC 019600064909
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2017·2017-06-14

    ConvaTec Recalls Adult Non-Rebreather Masks Due to Defect

    ConvaTec, Inc. is voluntarily recalling adult non-rebreather masks with 'No-Crush' tubing. The recall was initiated in May 2017 and is now terminated.

    Product
    Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
    Category
    Medical Device
    Distribution
    14 states