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.

41926–41950 of 50511

  • HighFDA (Devices)·Z-0897-2014·2014-02-05

    Synergetics 25ga Mid-Field Endo Illuminator Recalled for Seal Failure

    Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2014·2014-02-05

    BD BACTEC FX Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson & Co. is recalling 198 BD BACTEC FX instruments because a component may fail, causing false negative results in clinical specimens.

    Product
    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2014·2014-02-05

    Philips Brilliance CT Systems Recalled for Dose Calculation Issue

    Philips is recalling 23 Brilliance CT systems because the DoseRight feature may suggest higher radiation doses for large children than expected.

    Product
    Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0889-2014·2014-02-05

    Synergetics Recalls 23ga Wide Field Corona Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1436-2014·2014-02-05

    Lambs Farm Blueberry Bread Recalled for Undeclared Soy Allergen

    The Lambs Farm, Inc. is recalling Blueberry Bread loaves sold in Bread Trio gift boxes because the labels do not declare soy allergens.

    Product
    Blueberry Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2014·2014-02-05

    Synergetics Recalls 25ga Wide Field Corona Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 96 units of 25ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1433-2014·2014-02-05

    Lambs Farm Cookie Combo Recalled for Undeclared Milk and Wheat Allergens

    The Lambs Farm, Inc. is recalling Cheerful Cookie Combo tins because the labels fail to declare milk and wheat allergens.

    Product
    Cheerful Cookie Combo containing an assortment of Lemon Butter Cookies and Famous Butter Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2014·2014-02-05

    BD BACTEC FX 40 Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson is recalling two BD BACTEC FX 40 instruments because a defective component may cause false negative results in clinical specimens.

    Product
    BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2014·2014-02-05

    Stryker Recalls Sterile Teflon Tubes Due to Potential Seal Compromise

    Stryker is recalling 34 units of sterile Teflon tubes used in orthopedic nailing systems because laboratory testing indicated the sterile barrier seal may be compromised.

    Product
    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F1462-2014·2014-02-05

    NatureBox Salsa Spiced Nut Mix Recalled for Missing Wheat Allergen Labeling

    NatureBox is recalling 8,672 bags of Salsa Spiced Nut Mix because the ingredient list failed to disclose unbleached wheat flour and bulgur wheat.

    Product
    NatureBox Salsa Spiced Nut Mix; Net. WT: 4 oz. (113 g), Stand up Pouch, Vegan Ingredients: Almonds, Corn chips with flax (yellow corn masa, flax seed, soybean oil, salt), Cashews, seasoning ( tomato powder, salt, sugar, onion powder, garlic powder, spices, cilantro, lime…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0854-2014·2014-02-05

    GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues

    GE Healthcare is recalling CARESCAPE B650 and B850 monitors due to 25 reported safety issues involving alarms and connectivity.

    Product
    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2014·2014-02-05

    Orthofix Firebird Modular Screw Driver Recalled for Collet Malfunction

    Orthofix is recalling 443 Modular Screw Drivers because the collet may malfunction, preventing effective screw placement and delaying surgery.

    Product
    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V030000·2014-02-04

    Eldorado Buses Recalled for Fire Risk in Electrical Components

    Eldorado is recalling specific E-Z Rider II, Axess, and Passport buses because a potting compound in electrical components may conduct electricity and cause a fire.

    Product
    ELDORADO — ELDORADO AXESS, E-Z RIDER II, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14100·2014-02-04

    Lion Force Boys' Puffer Coats Recalled for Strangulation Hazard

    Lion Force is recalling boys' puffer coats sold at Burlington Coat Factory because the hood drawstrings pose a strangulation hazard to children.

    Product
    Lion Force Boys' Puffer Coats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14099·2014-02-04

    3T Design Recalls Cervélo P5 Bicycles with Aduro Handlebars

    3T Design is recalling Cervélo P5 bicycles with Aduro aero handlebars because the forward extension mounts can detach while riding, posing a risk of injury.

    Product
    Cervélo P5 bicycles with 3T Aduro aero handlebars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V033000·2014-02-04

    Heartland Recalls Fifth Wheel Travel Trailers Due to Incorrect Certification Label

    Heartland is recalling 2014 fifth wheel travel trailers equipped with optional 17.5-inch wheels because the Federal Certification Label contains incorrect wheel specifications.

    Product
    HEARTLAND — HEARTLAND GRAND CANYON, MONTEREY, SAN ANTONIO, SAVANNAH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·009-2014·2014-02-01

    House of Smoke Recalls Meat Products Due to Undeclared Soy Lecithin

    House of Smoke, Inc. is recalling approximately 144,000 pounds of meat and poultry products because they contain soy lecithin, a known allergen not declared on the label.

    Product
    House Of Smoke, Inc. — Colorado Firm Recalls Various Meat Products Due To Soy Lecithin
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·14097·2014-01-30

    Fred & Friends Recalls Infant Pacifiers Due to Choking Hazard

    Fred & Friends is recalling Chill Baby Artiste, Volume, and Panic pacifiers because parts can detach and pose a choking hazard to young children.

    Product
    Fred & Friends Chill Baby Artiste, Volume and Panic pacifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-758-2014·2014-01-29

    Novartis Recalls NeoCitran Powder Packets Due to Foreign Substances

    Novartis Consumer Health is recalling specific lots of NeoCitran powder packets because they may contain foreign substances. The products were distributed in the US, Canada, Mexico, and other countries.

    Product
    NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-818-2014·2014-01-29

    Mycophenolic Acid Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Mycophenolic Acid tablets that may be mislabeled as Methazolamide. The error could lead to patients taking the wrong medication.

    Product
    MYCOPHENOLIC ACID DR, Tablet, 180 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078038566.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0813-2014·2014-01-29

    Churchill Medical AMS-530 Microbore Extension Sets Recalled for Leaking

    Churchill Medical Systems is recalling AMS-530 Microbore Trifurcated Extension sets because a defective component may cause the sets to leak.

    Product
    AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide