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.

43026–43050 of 50511

  • HighNHTSA·13E048000·2013-08-27

    Polaris Recalls Lock & Ride Passenger Backrests for Crash Risk

    Polaris is recalling specific Lock & Ride passenger backrests for Victory motorcycles because they can fail if a luggage rack is attached, increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V384000·2013-08-27

    Sunset Park & RV Recalls 2014 EZ Traveler Trailer for Awning Defect

    Sunset Park & RV is recalling one 2014 EZ Traveler travel trailer because a design change in the power awning motor assembly may cause screws to shear, potentially allowing the awning to unfurl unexpectedly.

    Product
    SUNSET PARK & RV — SUNSET PARK & RV EZ TRAVELER (21LE)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V380000·2013-08-23

    Manning Equipment Recalls 2012 Ford F-Series Trucks for Exhaust Fire Risk

    Manning Equipment is recalling 37 model year 2012 Ford F-350, F-450, and F-550 trucks because the tailpipe design allows heat to build up in the rear storage compartment, posing a fire risk.

    Product
    FORD — FORD F-350, F-450, F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-881-2013·2013-08-21

    Verapamil Injection Is Recalled Over Sterility Assurance Concerns

    FDA is recalling Verapamil Injection compounded by Pallimed Solutions Pharmacy because inspectional findings raised concerns about quality-control procedures and sterility assurance. The recall covers all lots within expiry distributed nationwide.

    Product
    Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1784-2013·2013-08-21

    Square Mile Original Hard Apple Cider Recalled Due to Bursting Risk

    Craft Brewers Alliance Inc. is recalling Square Mile Original Hard Apple Cider because bottles may burst. The product was distributed in California, Oregon, and Washington.

    Product
    Square Mile Original Hard Apple Cider is hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1963-2013·2013-08-21

    Edwards Lifesciences Recalls Anastaflo Intravascular Shunts Due to Adhesive Concerns

    Edwards Lifesciences is recalling specific lots of Anastaflo intravascular shunts because excessive adhesive on the shunt body may interfere with suturing during bypass graft construction.

    Product
    Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1942-2013·2013-08-21

    GE Healthcare Recalls Mobile X-Ray Units Due to Erratic Drive Performance

    GE Healthcare is recalling Optima and Brivo mobile x-ray units because of erratic drive performance. The recall affects 458 units distributed worldwide.

    Product
    GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1785-2013·2013-08-21

    Square Mile Spur & Vine Hopped Apple Cider Recalled for Bursting Risk

    Craft Brewers Alliance Inc. is recalling Square Mile Spur & Vine Hopped Apple Cider because bottles may burst. The product was distributed in California, Oregon, and Washington.

    Product
    Square Mile Spur & Vine Hopped Apple Cider is hopped hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes…
    Category
    Food
    Distribution
    3 states
  • HighCPSC·13271·2013-08-21

    HALO SleepSack Wearable Blankets Recalled Due to Choking Hazard

    HALO SleepSack Wearable Blankets with Pink Satin Flowers are recalled because petals can detach and pose a choking hazard to infants.

    Product
    HALO® SleepSack® Wearable Blankets with Pink Satin Flowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2013·2013-08-21

    Synthes Flexible Medullary Reamer Recalled Due to Cleaning and Corrosion Risks

    Synthes USA is recalling 13,050 Flexible Medullary Reamers because the coiled design makes them difficult to clean, creating a risk of corrosion and foreign material introduction.

    Product
    Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2013·2013-08-21

    Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System Instrumentation due to potential tab fracture during use.

    Product
    REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1799-2013·2013-08-21

    Shoreline Fruit Recalls Dark Chocolate Covered Dried Cherries for Undeclared Sulfites

    Shoreline Fruit Inc is recalling Dark Chocolate Covered Dried Balaton Cherries because they may contain undeclared sulfites from cross-contamination with dark chocolate strawberries.

    Product
    Cherry Bay Orchards Dark Chocolate Covered Dried Balaton Cherries 4lb, 8oz, and 16oz containers
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1959-2013·2013-08-21

    GE Healthcare Recalls Disposable Temperature Probes Due to Safety Concerns

    GE Healthcare is recalling disposable temperature probes due to a potential safety issue with esophageal placement.

    Product
    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2013·2013-08-21

    GE Healthcare Recalls Signa MR Systems Due to Patient Data Mismatch Risk

    GE Healthcare is recalling multiple Signa MRI systems because a software issue can cause screen save images to be linked to the wrong patient exam, creating a risk of patient data mismatch.

    Product
    SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2013·2013-08-21

    Veridex CellTracks Analyzer II Recalled for Patient Data Association Error

    Veridex is recalling CellTracks Analyzer II software versions 2.5.1 and below because patient demographics were incorrectly associated with another patient's ID.

    Product
    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V378000·2013-08-21

    Altec Recalls Aerial Devices Due to Electrical Shock Risk

    Altec is recalling 2005-2013 AH75, AH85, and AH100 aerial devices because a cable may breach insulation, increasing the risk of electrical shock to operators.

    Product
    ALTEC — ALTEC AH100, AH75, AH85
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1801-2013·2013-08-21

    CHS Recalls IMAGIC Vegetarian Burger Mix Due to Salmonella Risk

    CHS Inc. is recalling IMAGIC Vegetarian Burger Mix because the soy protein isolate may be contaminated with Salmonella.

    Product
    IMAGIC Vegetarian Burger Mix, VB 100, textured vegetable protein, contains soy and wheat, packaged in 25-lb/bulk cartons. CHS Inc., Hutchinson, KS.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1954-2013·2013-08-21

    Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System instrumentation due to a potential for tab fracture during use.

    Product
    REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2013·2013-08-21

    Edwards Recalls EndoReturn Arterial Cannula Due to Component Error

    Edwards Lifesciences is recalling specific lots of the EndoReturn Arterial Cannula because an incorrect component was used, which may cause performance issues with the IntraClude device.

    Product
    Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2013·2013-08-21

    Carestream DRX Evolution X-Ray System Recalled for Exposure Technique Change

    Carestream Health is recalling DRX Evolution X-Ray systems due to a potential change in x-ray exposure technique.

    Product
    Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2013·2013-08-21

    GE LightSpeed CT750 HD Recalled for CT Number Variance and Software Issues

    GE Healthcare is recalling 244 GE LightSpeed CT750 HD systems due to CT number variance in head perfusion images and software defects.

    Product
    GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2013·2013-08-21

    Beckman Coulter Recalls ISE Electrolyte Reference Reagent for Calibration Issues

    Beckman Coulter is recalling ISE Electrolyte Reference reagent because it may exceed instrument calibration limits, potentially affecting potassium measurements.

    Product
    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s)…
    Category
    Medical Device
    Distribution
    Distributed nationwide