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.

37876–37900 of 50506

  • HighFDA (Devices)·Z-2458-2015·2015-09-02

    Medline Recalls Central Line Kits Due to Incorrect Age Labeling

    Medline Industries is recalling Central Line kits due to a printing error that mislabels the intended patient age. The error could lead to use on the wrong patient population.

    Product
    Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2455-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1352-2015·2015-09-02

    Unichem Recalls Hydrochlorothiazide Tablets Due to Foreign Tablet Presence

    Unichem Pharmaceuticals is recalling 4,776 bottles of hydrochlorothiazide 25 mg tablets because a pharmacist found a clopidogrel tablet in one bottle.

    Product
    HYDROCHLOROTHIAZIDE — HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2015·2015-09-02

    Recall of Infant Heel Warmers Due to Potential Breakage and Spillage

    The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.

    Product
    Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2015·2015-09-02

    FDA Recalls Covidien Infant Heel Warmers Due to Breakage Risk

    The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.

    Product
    Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3057-2015·2015-09-02

    Bruce Foods Recalls Louisiana Chicken Wing Seasoning for Peanut Contamination

    Bruce Foods Corporation is recalling 22 cases of Louisiana Chicken Wing Seasoning because the product may be contaminated with peanut protein.

    Product
    LOUISIANA CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-3049-2015·2015-09-02

    Veggie Evolution Kale Crisps Recalled for Undeclared Milk Allergen

    It Takes A Village Foods is recalling Veggie Evolution Kale Crisps Lemon Parmesan because the label lists Parmesan cheese but fails to declare milk as an allergen.

    Product
    Kale Crisps Lemon Parmesan sold under brand Veggie Evolution, each plastic package has a net weight 1.5 oz. There are six packages per case. UPC is 7 94504 69431 4. The product's label is read in part: "***VEGGIE EVOLUTION***KALE CRISPS***LEMON PARMESAN***INGREDIENTS: KALE…
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-2467-2015·2015-09-02

    Sunrise Medical Recalls Quickie IRIS Wheelchairs with Dynamic Backrest

    Sunrise Medical is recalling 64 Quickie IRIS wheelchairs because the backrest system may break, posing a risk of falls or injury to the occupant.

    Product
    Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2015·2015-09-02

    RayStation 4.7.1 Radiation Therapy Software Recalled for Algorithm Error

    RaySearch Laboratories is recalling RayStation 4.7.1 software due to an algorithm error that reverses contraction distances in radiation therapy planning.

    Product
    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    7 states
  • HighCPSC·15230·2015-09-02

    Tadpoles Moses Basket and Stand Recalled for Fall Hazard

    Sleeping Partners is recalling Tadpoles Moses baskets and stands because the basket can slide off inclined surfaces and the stand can tip, posing a fall hazard to infants.

    Product
    Tadpoles Baby and Kids Moses Basket and Stand
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3050-2015·2015-09-02

    Veggie Evolution Vegetable Crisps Recalled for Undeclared Milk Allergen

    It Takes A Village Foods, LLC is recalling Vegetable Crisps Lemon Parmesan because the label declares Parmesan cheese but fails to declare milk as an allergen.

    Product
    Vegetable Crisps Lemon Parmesan sold under brand Veggie Evolution, each poly pouch has a net weight 2 oz. There are 6 packages per case. UPC is 7 36211 15015 8. The product's label is read in part: "***VEGGIE EVOLUTION***VEGETABLE CRISPS***LEMON PARMESAN***INGREDIENTS…
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-3058-2015·2015-09-02

    Bruce Foods Recalls Louisiana Wing Kit for Peanut Contamination

    Bruce Foods Corporation is recalling 'Louisiana' Wing Kits due to potential peanut protein contamination. The product was distributed in nine states.

    Product
    "LOUISIANA" WING KIT containing CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153 (wing seasoning)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2466-2015·2015-09-02

    Sunrise Medical Recalls Quickie and Zippie IRIS Wheelchairs with MONO Backrest

    Sunrise Medical is recalling 64 Quickie and Zippie IRIS wheelchairs because the MONO Backrest System may break, posing a risk of falls or injury to the occupant.

    Product
    Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2439-2015·2015-09-02

    PTW UNIDOS webline Dosimeters Recalled for Potential Radiation Over-Exposure

    PTW-Freiburg is recalling PTW UNIDOS webline dosimeters because measurement errors at high dose rates could display too-low doses, potentially leading to radiation over-exposure.

    Product
    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2461-2015·2015-09-02

    Ferno iNX Wheeled Stretcher Wheel Caster Set Screw Recall

    Ferno-Washington Inc is recalling 26 Ferno iNX Wheeled Stretchers due to improperly installed wheel caster set screws that may allow bearing cups to back out.

    Product
    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2445-2015·2015-09-02

    FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect

    Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.

    Product
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V555000·2015-09-02

    Volvo Recalls 2016 Models Due to Starter Motor Fuse Failure Risk

    Volvo is recalling 7,855 model year 2016 vehicles because a starter motor fuse may blow, preventing the car from restarting in traffic and increasing crash risk.

    Product
    VOLVO — VOLVO S60, V60, XC60, XC70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3056-2015·2015-09-02

    Bruce Foods Chicken Fry Mix Recalled for Peanut Contamination

    Bruce Foods is recalling 147 cases of Chicken Fry Mix because the product may be contaminated with peanut protein.

    Product
    THE ORIGINAL CHICKEN FRY MIX FROM THE MAKERS OF LOUISIANA BRAND HOT SAUCE, NET WT. 9 oz. (255g), BRUCE FOODS CORPORATION, EL PASO, TEXAS, UPC 1760002733
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2450-2015·2015-09-02

    Siemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling 1,655 Dimension Vista B2-Microglobulin Flex Reagent Cartridges due to potential reagent contamination that may cause falsely low test results.

    Product
    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2015·2015-09-02

    Philips DigitalDiagnost X-ray Systems Recalled for Missing Exposure Beep Signal

    Philips is recalling 62 DigitalDiagnost X-ray systems because a software defect prevents the exposure termination beep from sounding after 12 hours of operation.

    Product
    Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15E072000·2015-09-02

    Peter Paul Nitrous Oxide Solenoid Valve Recall for Potential Breakage

    Peter Paul Electronics is recalling specific nitrous oxide solenoid valves because end stops may break under pressure, posing an injury risk to nearby individuals.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V549000·2015-09-01

    Spartan Motorhomes Recalled for Potential Engine Cooling Fan Separation

    Spartan Motors USA is recalling 2004-2008 K2, K3, and MM motorhomes because the engine cooling fan may separate from the drive, posing an injury risk to nearby individuals.

    Product
    SPARTAN — SPARTAN MM, K3, K2
    Category
    Vehicle
    Distribution
    Distributed nationwide