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.

41126–41150 of 50511

  • HighFDA (Devices)·Z-1709-2014·2014-06-11

    LAP Laser Software Recall Due to Incorrect Patient Marking Instructions

    LAP of America is recalling CARINAsim and CARINAiso laser software manuals due to errors that may cause incorrect patient marking.

    Product
    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1707-2014·2014-06-11

    Brainlab ExacTrac 5.5 Image Processing System Recalled for Plan Blending Error

    Brainlab AG is recalling ExacTrac 5.5 image processing systems because a specific workflow may generate unintended blends of separate patient treatment plans.

    Product
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1992-2014·2014-06-11

    Greens+ Vegan Crisp Bars Recalled for Undeclared Milk Protein

    Orange Peel Enterprises is recalling Greens+ Vegan Crisp Bars due to undeclared milk protein in the chocolate coating.

    Product
    Greens+ Vegan Crisp Bars - Dark Chocolate Peanut Butter in 1.4 oz packages.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-1717-2014·2014-06-11

    Siemens Ysio Systems Recalled for Potential Unintended Radiation Release

    Siemens is recalling 433 Ysio radiographic systems because excessive cleaning liquid usage may cause a short circuit, leading to unintended radiation release.

    Product
    Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2014·2014-06-11

    Aesculap Miethke Ventricular Catheter Recalled Due to Deflector Movement Issues

    Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector because the deflector did not move freely in three reported cases.

    Product
    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1704-2014·2014-06-11

    Hospira Recalls Infusion Pumps Due to Door Roller Assembly Breakage Risk

    Hospira is recalling specific Plum XL and LifeCare infusion pumps because a door roller assembly may break, preventing the cassette door from locking properly.

    Product
    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14202·2014-06-10

    SCOTT Recalls Speedster Bicycles Due to Front Fork Breakage Hazard

    SCOTT is recalling 2014 Speedster and Contessa Speedster road bicycles because the front fork steerer tube can break, posing a fall hazard.

    Product
    2014 SCOTT® Speedster 30 and 40, and Contessa Speedster 25 and 35 road bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V382000·2014-06-10

    Ford Super Duty Chassis Recalled for PTO Oil Leak Fire Risk

    Somerset Welding & Steel is recalling 2009-2013 Ford F-350, F-450, and F-550 Super Duty chassis with specific PTO assemblies due to a fire risk from oil leaks.

    Product
    FORD — FORD F-550 SD, F-350 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14203·2014-06-10

    Weil-McLain Recalls Ultra Series Boilers Due to Fire and Explosion Risk

    Weil-McLain is recalling approximately 7,900 Ultra Series gas-fired boilers in the U.S. because a manifold cap can crack and release gas, posing a risk of fire and explosion.

    Product
    Weil-McLain Ultra models 80, 105, 155 and 230 MBH Ultra Series Boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V370000·2014-06-09

    MCI Recalls 2014 Motor Coaches Due to Headlight Software Defect

    Motor Coach Industries is recalling 686 model year 2014 motor coaches because a software defect may cause headlights to turn off while driving, increasing crash risk.

    Product
    MCI — MCI D4505, D4000ISTV, D4005, D4000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V298000·2014-06-06

    GM Recalls 2013 Buick Encore and Chevrolet Spark for Air Bag Defect

    General Motors is recalling specific 2013 Buick Encore and Chevrolet Spark vehicles because an improper weld may prevent the passenger air bag from deploying, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET, BUICK SPARK, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V301000·2014-06-06

    GM Recalls 2014-2015 Trucks and SUVs for Radio Software Defect

    General Motors is recalling specific 2014-2015 Chevrolet and GMC vehicles because a radio software defect may disable audible safety warnings for open doors and unbuckled seat belts.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, TAHOE, SIERRA, SIERRA HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14735·2014-06-04

    Lea Bunk Beds Recalled Due to Entrapment Hazard

    Lea Industries is recalling Covington and Hannah Collection bunk beds because incorrect assembly can create a space that traps young children.

    Product
    Lea Covington and Hannah Collection Bunk Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1660-2014·2014-06-04

    Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns

    Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.

    Product
    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2014·2014-06-04

    Medtronic Temporary Pacemaker Recalled for Pacing Rate Defect

    Medtronic is recalling 16,337 temporary pacemakers worldwide because oxidation on internal contacts can cause the pacing rate to increase unexpectedly to 180 pulses per minute.

    Product
    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1672-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift

    Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.

    Product
    ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1979-2014·2014-06-04

    Dr. Mercola Organic Cocoa Cassava Bars Recalled for Undeclared Milk

    Mercola Group is voluntarily recalling Dr. Mercola Organic Cocoa Cassava bars because they may contain undeclared milk protein.

    Product
    Organic Cocoa Cassava bars, 1.59 oz (45 g), individually packaged in foil pouches and sold under the Dr. Mercola brand. Sold at retail locations in display cases containing 12 bars per display case. 12 display cases are packaged in each master case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14V304000·2014-06-04

    Van Hool Recalls TX40 and TX45 Motorcoaches for Seat Belt Defect

    Van Hool is recalling 2014-2015 TX40 and TX45 motorcoaches because the driver seat belt may not be properly secured, increasing injury risk in a crash.

    Product
    VAN HOOL — VAN HOOL TX40, TX45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift

    Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.

    Product
    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1975-2014·2014-06-04

    Asian Bakery Recalls Cakes Due to Undeclared Milk, Wheat, and Soy

    Asian Bakery is recalling Chernosliv cakes due to undeclared milk, wheat, and soy lecithin. The products were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Chernosliv cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states