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.

35451–35475 of 50504

  • HighFDA (Devices)·Z-1999-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT S(20) - 3R scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling 328 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2016·2016-06-22

    Oasis Trading Recalls Chef's Quality Soybean Oil Due to Foreign Material

    Oasis Trading Co., Inc. is recalling Chef's Quality Soybean Oil because bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Soybean Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: RD/JET LLC, 15-24 132nd Street, College Point, NY 11356, UPC 7 60695 00931 2
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1487-2016·2016-06-22

    CSM Bakery Red Velvet Cake Recalled for Unlabeled Peanut Trace

    CSM Bakery Products is recalling 8-inch single-layer red velvet cakes because lab testing found trace amounts of peanuts, which were not declared on the label.

    Product
    8 " Single Layer Red Velvet Cake
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1970-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specifications that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1440-2016·2016-06-22

    CSM Bakery Recalls Frozen Ginger Cookies for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling frozen TranSmart Ginger Cookies because they contain undeclared peanut protein. The recall covers 34,525 cases distributed across 20 US states and Colombia.

    Product
    TranSmart, Ginger Cookie, 300-1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg (Frozen).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1443-2016·2016-06-22

    CSM Bakery Recalls Wedding Cookies Due to Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling TranSmart Gourmet Mini Bites Wedding Cookies because they contain undeclared peanut protein.

    Product
    TranSmart Gourmet Mini Bites Wedding Cookie, 576, .75oz cookies, Net Wt 27 lbs/12.26 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1959-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to a potential for polystyrene particulate presence.

    Product
    BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1458-2016·2016-06-22

    CSM Bakery Products Recalls Macadamia Nut Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling 4 oz. Macadamia Nut Cookie Dough because it contains undeclared peanut protein. The product was distributed in 20 U.S. states and Colombia.

    Product
    4 oz. Macadamia Nut Cookie Dough, TranSmart, Net Weight 24 lbs/10.9 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1519-2016·2016-06-22

    Harris Teeter Recalls White Chocolate Macadamia Cookies for Undeclared Peanut

    Harris Teeter is recalling Gourmet White Chocolate Macadamia Cookies because they contain undeclared peanut protein. The recall affects 8,048 units distributed in seven states.

    Product
    Gourmet White Chocolate Macadamia Cookies, UPC 0007203695132, 4 Ct (Pack 24/4 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1987-2016·2016-06-22

    Navilyst Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 190 units of BioFlo Hybrid PICC catheters because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1459-2016·2016-06-22

    CSM Bakery Recalls 7 Eleven Sugar Cookies Due to Undeclared Peanut

    CSM Bakery Products NA is recalling 7 Eleven Sugar Cookies because they contain undeclared peanut protein. The product was distributed in 19 states and Colombia.

    Product
    7 Eleven, Sugar Cookie (2.2 oz. Pucks), Net Weight 33 lbs (14.96 kg), Manufactured by; CSM Bakery, Tucker, GA 30084.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1973-2016·2016-06-22

    Navilyst Medical Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 150 units of Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1492-2016·2016-06-22

    Oasis Foods Creamy Liquid Fry Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling 2,360 containers of Oasis Foods Creamy Liquid Fry Shortening because the product was reported to contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Creamy Liquid Fry Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc., Hillside, NJ 07205, UPC 7 32146 10540 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1964-2016·2016-06-22

    Staar Surgical Recalls STAAR AQ Cartridge-FP Intraocular Lens Delivery Systems

    Staar Surgical Co. is recalling 2,612 units of the STAAR AQ Cartridge-FP because the device may crack during loading or delivery of intraocular lenses.

    Product
    STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·16V449000·2016-06-21

    GM Recalls 2016 Chevrolet Equinox and GMC Terrain for Incorrect Tire Labels

    General Motors is recalling specific 2016 Chevrolet Equinox and GMC Terrain vehicles because their certification labels may display incorrect tire and rim size information.

    Product
    GMC — GMC, CHEVROLET TERRAIN, EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V451000·2016-06-21

    Gillig Recalls 2012-2016 Low Floor Vehicles Due to Flashing Brake Lights

    Gillig is recalling 112 model year 2012-2016 Low Floor vehicles because the rear brake lights may flash inadvertently, which could confuse other drivers and increase crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V453000·2016-06-21

    Navistar Recalls 2017 International Trucks Due to Engine Stall Risk

    Navistar is recalling 1,191 model year 2017 International trucks because an electrical short in the engine control module can cause the engine to stall without restarting.

    Product
    INTERNATIONAL — INTERNATIONAL PROSTAR, LONESTAR, PAYSTAR, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide