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.

41676–41700 of 50511

  • HighFDA (Food)·F-1559-2014·2014-03-05

    Marlyce's Homemade Style Noodles Recalled for Undeclared Wheat Allergen

    L.M. Noodle Company is recalling Marlyce's Homemade Style Noodles because the label fails to declare wheat flour, a major allergen.

    Product
    Marlyce's Homemade Style Noodles, Net Wt. 8 oz, Packaged in plastic bags, 10 per case, UPC 094219217069. Manufactured by L.M.Noodle Company, LLC, 416 Main Street, Wiggins, CO 80654.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1571-2014·2014-03-05

    CSM Bakery Recalls Pistachio Muffins for Undeclared Coconut

    CSM Bakery Products NA is recalling 60 cases of frozen pistachio muffins because they may contain undeclared coconut.

    Product
    Multifoods Bakery Products, Artificial Pistachio Flavored Muffin with Other Nuts, 4.5oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 27 lbs case is unit for sale. UPC 024800486383. Manufactured by CSM…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1577-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with mango filling due to undeclared wheat allergens. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***mango filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1098-2014·2014-03-05

    Fresenius Optiflux Dialyzers Recalled for Dialysate Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F160NRe dialyzers because the dialysate port may leak during priming. The recall covers 3.4 million units distributed in the US and Mexico.

    Product
    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2014·2014-03-05

    Stryker Recalls Static Inserter Assemblies Due to Weld Fracture Complaints

    Stryker Spine is recalling 21 units of Specialty Straight Static Inserter Assemblies because customers reported fractures along the weld binding the handle to the shaft.

    Product
    Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wear Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because therapy connections may wear prematurely, posing a risk to patients and caregivers.

    Product
    Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2014·2014-03-05

    Fresenius Optiflux F200A Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling 5,244 Optiflux F200A dialyzers due to a dialysate port leak during priming.

    Product
    Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2014·2014-03-05

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to Contamination

    Remel Inc is recalling specific lots of Oxoid Legionella BCYE Growth Supplement because the product may contain high levels of microbial contamination.

    Product
    Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1588-2014·2014-03-05

    E. Franco & Co. Recalls Rolled Cakes with Undeclared Wheat Allergen

    E. Franco & Co. Inc is recalling Brazo gitano rolled cakes with pineapple-cheese filling due to undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***pineapple-cheese filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1078-2014·2014-03-05

    GE Healthcare Wireless Digital Radiography Software Recall for Patient Safety

    GE Healthcare is recalling Wireless Digital Radiography Option (WDR1) software due to a defect that may cause patient exams to display incorrectly, potentially impacting patient safety.

    Product
    GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2014·2014-03-05

    Winco XL Convalescent Recliner Recalled Due to Assembly Defect

    Winco Mfg. is recalling 369 XL Convalescent Recliners due to a manufacturing defect in the right-hand recline mechanism that may cause loss of the position lock bar functionality.

    Product
    XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1572-2014·2014-03-05

    E. Franco & Co. Recalls Rolled Cakes Due to Undeclared Wheat Allergen

    E. Franco & Co. Inc is recalling approximately 2,300 rolls of Brazo gitano (rolled cake) with pineapple paste filling because the product contains undeclared wheat. The recall is limited to Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***pineapple paste filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1560-2014·2014-03-05

    Creation Gardens Recalls Bar Star Snack Mix for Missing Allergen Labels

    Creation Gardens is recalling Bar Star Snack Mix because the packaging lacks required ingredient and allergen statements, including peanuts, tree nuts, soy, and wheat.

    Product
    Bar Star Snack Mix, 1 lb plastic bag and 25 lb plastic bags in a cardboard box. Box labeled DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405 with a white stick on label which reads, "25# BAR STAR MIX
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1116-2014·2014-03-05

    Winco Drop-Arm Convalescent Recliners Recalled for Mechanism Defect

    Winco Mfg. is recalling 369 drop-arm convalescent recliners due to a manufacturing defect that may cause the three-position lock bar to lose functionality.

    Product
    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2014·2014-03-05

    Fresenius Optiflux F180NRe Dialyzers Recalled for Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F180NRe dialyzers because the dialysate port may leak during priming, potentially compromising treatment.

    Product
    Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1578-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. is recalling Brazo gitano (rolled cake) with cheese filling due to undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***cheese filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1570-2014·2014-03-05

    CSM Bakery Recalls Cranberry Orange Muffins for Metal Dust Contamination

    CSM Bakery Products NA is recalling Cranberry Orange Muffins because they may contain metal dust. The affected products were distributed to Massachusetts and Wisconsin.

    Product
    Multifoods Bakery Products, Cranberry Orange Muffins, 5.4oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 25.3lbs case is unit for sale. UPC 10035074485443. Manufactured by: CSM Bakery NA, Inc, Tucker, GA.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1115-2014·2014-03-05

    Winco Convalescent Recliners Recalled for Recline Mechanism Defect

    Winco Mfg. is recalling 369 convalescent recliners due to a manufacturing defect in the right hand recline mechanism that may cause the position lock bar to lose functionality.

    Product
    CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2014·2014-03-05

    Fresenius Optiflux F180NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F180NR dialyzers due to a dialysate port leak during priming. The recall covers 52,752 units distributed in the US and Mexico.

    Product
    Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1584-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes Due to Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with strawberry filling because it contains undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***strawberry filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1586-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with coconut-pineapple filling due to undeclared wheat allergens. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***coconut-pineapple filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1587-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. is recalling Brazo gitano rolls with papaya-cheese filling sold in Puerto Rico due to undeclared wheat.

    Product
    "***Brazo gitano (rolled cake)***papaya-cheese filling***"
    Category
    Food
    Distribution
    1 state