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.

41826–41850 of 50511

  • HighFDA (Devices)·Z-0945-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Endotoxin Testing

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2014·2014-02-19

    Integra Recalls Malibu Polyaxial Screwdrivers Due to Potential Shaft Breakage

    Integra LifeSciences is recalling 40 Malibu Polyaxial Screwdrivers because the shaft may break during use. No patient injuries have been reported.

    Product
    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-1482-2014·2014-02-19

    Araya Marshmallows Recalled for Undeclared Allergens

    Araya, Inc. is recalling various flavored marshmallows because they may contain undeclared allergens. The recall covers wholesale and internet sales nationwide.

    Product
    Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread, peppermint, red velvet, vanilla Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1485-2014·2014-02-19

    Araya Chocolate S'mores Recalled for Undeclared Allergens

    Araya, Inc. is recalling Chocolate S'mores because the product may contain undeclared allergens. The recall covers 2,264 wholesale units and internet sales distributed nationwide.

    Product
    Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·14715·2014-02-18

    Club Car Recalls Precedent I2 Golf Vehicles Due to Fall Hazard

    Club Car is recalling about 1,800 Precedent I2 golf and transport vehicles because the passenger-side hip restraint can fracture, posing a fall hazard.

    Product
    Precedent I2 golf and transport vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14106·2014-02-18

    LEM 5-Tray Food Dehydrators Recalled for Electrical Shock Hazard

    LEM Products is expanding a recall of 5-tray food dehydrators due to damaged wiring that poses a shock hazard. Consumers should stop using the units and contact the company for repair.

    Product
    5-Tray Dehydrators with Digital Timers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2014·2014-02-12

    Edwards Lifesciences Recalls 26mm Transcatheter Heart Valve Crimpers

    Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.

    Product
    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2014·2014-02-12

    CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak

    CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.

    Product
    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2014·2014-02-12

    ITC-Nexus Dx Recalls Hemochron Jr. Citrate APTT Cuvettes for Inaccurate Results

    ITC-Nexus Dx is recalling Hemochron Jr. Citrate APTT Cuvettes because they may produce higher than expected results in normal individuals.

    Product
    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2014·2014-02-12

    ArjoHuntleigh Rotoprone Therapy System Recalled for Lock Pin Malfunction

    ArjoHuntleigh is recalling 231 Rotoprone Therapy Systems because a lock pin can become stuck, preventing patients from being positioned prone.

    Product
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14104·2014-02-12

    Visonic Amber Personal Emergency Response Kits Recalled for Signal Failure

    Visonic Amber SelectX kits are recalled because base stations may fail to detect emergency signals after a reboot. No injuries have been reported.

    Product
    Visonic Amber SelectX Personal Emergency Response System (PERS) Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2014·2014-02-12

    GE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss

    GE Healthcare is recalling 12,945 CARESCAPE Monitor B850 units worldwide because the F5-01 Frame may lose communication with the patient monitor.

    Product
    CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2014·2014-02-12

    CareFusion Recalls SmartSite Needleless Connectors Due to Connection Issues

    CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.

    Product
    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation T-Piece Upgrade Kits

    GE Healthcare is recalling 561 infant resuscitation T-piece upgrade kits because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 48 Stand-Alone Resuscitation Units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V071000·2014-02-12

    Three Feathers Recalls Trailers With Defective Door Locks

    Three Feathers is recalling 480 trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    THREE FEATHERS — THREE FEATHERS MULE CARGO HAULER, PELICAN CARGO HAULER, PINECONE TEAR DROP TRLR, TUMBLEWEED CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2014·2014-02-12

    Ossur Recalls Symbionic Leg Prostheses Due to Electronics Defect

    Ossur is recalling 17 Symbionic Leg prostheses due to a possible defect in a small batch of electronics. The recall affects units distributed in seven US states and DC.

    Product
    The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1465-2014·2014-02-12

    Lenguita Cookies Recalled for Undeclared Wheat Allergen

    Gotera, Inc is recalling Lenguita Cookies because the product contains undeclared wheat. The recall affects 217 cases distributed across nine states.

    Product
    Lenguita Cookies net wt. 6 oz., Distributed by Mama Lycha Foods, Houston TX 77055 toll free (877)MAMALYCHA email [email protected] www.mamalycha.com Product of Honduras
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0914-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 15 infant resuscitation units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14105·2014-02-12

    MAT Industries Recalls HDX and Powermate Air Compressors Due to Shock Hazard

    MAT Industries is recalling HDX and Powermate two-gallon air compressors because pressure switch terminals can contact the motor housing, posing a shock hazard.

    Product
    HDX™ and Powermate® two-gallon air compressors
    Category
    Consumer Product
    Distribution
    Distributed nationwide