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.

39376–39400 of 50506

  • HighUSDA FSIS·045-2015·2015-03-14

    Gourmet Kitchen Recalls Beef and Chicken Products for Undeclared Peanuts

    Gourmet Kitchen Inc. is recalling approximately 16,722 pounds of beef and chicken appetizers due to misbranding and an undeclared peanut allergen.

    Product
    Gourmet Kitchen Inc — Gourmet Kitchen Inc. Recalls Various Beef and Chicken Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·15V145000·2015-03-13

    GM Recalls 2011-2013 Chevrolet Volt for Carbon Monoxide Risk

    General Motors is recalling 2011-2013 Chevrolet Volt vehicles because the engine may start automatically if the electrical system is left on, posing a carbon monoxide risk in enclosed spaces.

    Product
    CHEVROLET — CHEVROLET VOLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V148000·2015-03-13

    BMW Recalls 2015 Convertibles Due to Air Bag Timing Error

    BMW is recalling 2015 428i and 435i Convertibles because a programming error may cause the driver's front air bag to deploy at the wrong time, increasing injury risk in a crash.

    Product
    BMW — BMW 428I, 435I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·043-2015·2015-03-12

    L & L Foods Recalls Bacon Bits for Undeclared Soy Allergen

    L & L Foods is recalling 30,665 pounds of bacon bits because the product contains soy lecithin, an allergen not listed on the label.

    Product
    Hearthside Food Solutions, LLC d/b/a Maker's Pride — L & L Foods Recalls Bacon Bits Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1242-2015·2015-03-11

    Biosense Webster Recalls LASSO NAV Duo Loop eco Catheters

    Biosense Webster is recalling LASSO NAV Duo Loop eco Catheters due to reports of difficulty retracting and damage to the spine cover.

    Product
    LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0396-2015·2015-03-11

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc. is voluntarily recalling 51,472 cartons of Vancomycin Hydrochloride Capsules, USP, 125 mg, because the drug is subpotent.

    Product
    Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2015·2015-03-11

    Zipline Medical Recalls Zip 8i Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 8i Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2015·2015-03-11

    Philips Allura Xper X-Ray Angiographic Software Recall

    Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.

    Product
    Philips Medical System Allura Xper X-Ray Angiographic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2015·2015-03-11

    Zipline Medical Recalls Zip 16 Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 16 Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1384-2015·2015-03-11

    LaRosa's Italian Dressing Recalled for Undeclared Allergens

    T. Marzetti Company is recalling LaRosa's Italian Dressing packets because the ingredient labels were switched, potentially leaving undeclared milk, egg, or sulfite allergens.

    Product
    LaRosa's Italian Dressing, 1.5oz plastic packet. Labeled in part, "INGREDIENTS: Soybean Oil, Water, Cultured ?Buttermilk, Distilled Vinegar, Romano Cheese, Part Skim Milk***Egg Yolk***Whey Protein Concentrate***CONTAINS: MILK EGGS***Packed for LaRosa's Inc, Cincinnati, OH 45238"…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1243-2015·2015-03-11

    iCAD Recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

    iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 because a device malfunction may cause biopsy needles to miss targets, potentially leading to incorrect diagnoses.

    Product
    DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2015·2015-03-11

    Maquet Servo-I Ventilator CO2 Analyzer Recalled for Calibration Defect

    Maquet is recalling 486 Servo-I ventilator CO2 analyzers worldwide due to a calibration problem caused by an internal circuit board defect.

    Product
    Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2015·2015-03-11

    Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns

    Zipline Medical is recalling Zip 8M Wound Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2015·2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Defects

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack was found that may cause air to leak.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1221-2015·2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack may cause air to leak. The recall affects 5 cases distributed to specific US states and Japan.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1237-2015·2015-03-11

    Elekta Monaco Radiation Therapy System Recalled for Incorrect CT to ED Conversion

    Elekta, Inc. is recalling Monaco radiation therapy treatment planning systems because the Image Statistics Tool may incorrectly convert CT to ED values.

    Product
    Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15094·2015-03-11

    SCARPA Recalls F1 EVO Ski Boots Due to Fall Hazard

    SCARPA is recalling F1 EVO ski boots because the Tronic system may fail to release from bindings, posing a fall hazard.

    Product
    F1 EVO Ski Boots with Tronic system component
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2015·2015-03-11

    Halyard Health Recalls KimVent Wet Pak Closed Suction Systems

    Halyard Health is recalling KimVent Wet Pak closed suction systems because a defect may cause air leaks.

    Product
    KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1244-2015·2015-03-11

    Elekta Focal Sim radiation therapy system recalled for image statistics error

    Elekta, Inc. is recalling 907 Focal Sim radiation therapy treatment planning systems because the Monaco Image Statistics Tool may produce incorrect CT to ED values.

    Product
    Focal Sim radiation therapy treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results

    Siemens is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1379-2015·2015-03-11

    MegaMex Recalls Herdez Chilpotle Peppers for Undeclared Wheat Allergen

    MegaMex Foods is recalling Herdez Chilpotle Peppers due to an undeclared wheat allergen. The recall covers 58,749 cases distributed nationwide.

    Product
    Herdez Chilpotle Peppers, 7oz., Item No. 52738, UPC 072878285131
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2015·2015-03-11

    Xoran MiniCAT X-ray devices recalled for imaging and dose defects

    Xoran Technologies is recalling 432 MiniCAT X-ray imaging devices nationwide due to out-of-tolerance kVp, unexposed frames, and out-of-tolerance dose.

    Product
    Xoran MiniCAT X-ray imaging device
    Category
    Medical Device
    Distribution
    Distributed nationwide