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.

41576–41600 of 50511

  • HighFDA (Devices)·Z-1266-2014·2014-03-26

    Otto Bock Recalls Aerial Wheelchair Cushions Due to Flammability Risk

    Otto Bock is recalling Aerial and Aerial Active wheelchair cushions because internal testing found a small risk of flammability after high-temperature washing.

    Product
    Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1240-2014·2014-03-26

    Convatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 54,590 Toray Hydrocoat Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1223-2014·2014-03-26

    Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1221-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena…
    Category
    Medical Device
    Distribution
    15 states
  • HighNHTSA·14V142000·2014-03-26

    Nissan Recalls 2013 Pathfinders for Transmission Hose Defect

    Nissan is recalling 2013 Pathfinders because a transmission hose may detach, causing fluid leaks and loss of acceleration.

    Product
    NISSAN — NISSAN PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2014·2014-03-26

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 5 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1675-2014·2014-03-26

    Good Neighbors Specialty Foods Recalls Tabouli Salad Due to Foreign Object

    Good Neighbors Specialty Foods is recalling Tabouli Salad because a customer found a blade inside the product.

    Product
    Good Neighbors Specialty Foods Tabouli Salad; 8 oz plastic container; UPC 18561500007 and 14 oz plastic container; 18561500068
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1245-2014·2014-03-26

    GE Healthcare Recalls CT Scanners Due to Head Scan Software Artifact

    GE Healthcare is recalling Optima CT580 and Discovery CT590RT scanners running software version 13BW16.3 because a software issue may cause artifacts that hide pathology during head scans.

    Product
    GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V138000·2014-03-25

    Nissan and Infiniti Recall Vehicles Due to Passenger Airbag Software Defect

    Nissan is recalling specific 2013-2014 models because software may incorrectly classify an occupied passenger seat as empty, potentially deactivating the airbag.

    Product
    INFINITI — INFINITI, NISSAN QX60, Q50, LEAF, PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V136000·2014-03-21

    Keystone Recalls Fifth Wheel Trailers with Defective Frigidaire Microwaves

    Keystone is recalling specific 2013-2014 fifth wheel trailers because the installed Frigidaire microwaves may start on their own, posing a fire risk.

    Product
    KEYSTONE — KEYSTONE DUTCHMEN VOLTAGE, DUTCHMEN INFINITY, ALPINE, MONTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14136·2014-03-20

    Minga Recalls Wooden Flipping Acrobat Toys for Lead Paint Violation

    Minga Fair Trade Imports is recalling wooden flipping acrobat toys because the paint contains excessive levels of lead, which is prohibited under federal law.

    Product
    Wooden flipping acrobat toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14725·2014-03-20

    Bedz King Recalls Bunk Beds with Side Ladders Due to Entrapment Hazard

    Bedz King is recalling specific bunk bed models with side ladders because a protruding corner post creates an entrapment hazard. No injuries have been reported.

    Product
    Bedz King Bunk Beds with Side Ladder
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14135·2014-03-19

    Ganz Recalls Grumpy Cat Stuffed Animals Due to Choking Hazard

    Ganz is recalling three styles of Grumpy Cat plush toys because their eyes can detach, posing a choking hazard to young children.

    Product
    Three styles of Plush Grumpy Cat stuffed animal toys.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1667-2014·2014-03-19

    Pecan Shed Recalls Candied Pecans Due to Undeclared Soy Allergen

    Pecan Shed is recalling milk chocolate candied pecans because they contain undeclared soy. The product was sold in retail stores and online to customers in several states.

    Product
    Candied pecans: milk chocolate
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1163-2014·2014-03-19

    GE Healthcare Recalls Innova X-ray Systems for Unexpected Power Loss

    GE Healthcare is recalling Innova cardiovascular X-ray systems because they may unexpectedly stop delivering X-rays, causing a loss of real-time imaging.

    Product
    GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2014·2014-03-19

    Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure

    Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.

    Product
    G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1199-2014·2014-03-19

    GE Healthcare Recalls Varicam and VG Hawkeye Imaging Devices

    GE Healthcare is recalling Varicam and VG Hawkeye nuclear medicine devices due to a potential safety issue where the detector may drift toward the patient.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1650-2014·2014-03-19

    Hudson Valley Homestead Bushwhacker's Savory Sauce Recalled for Undeclared Anchovies

    Hudson Valley Homestead is recalling Bushwhacker's Savory Sauce due to undeclared anchovies, a potential allergen hazard.

    Product
    HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Mild, Net Wt. 14 oz., UPC: 7 51122 00091 0, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1165-2014·2014-03-19

    Maquet Plegiox Cardioplegia Heat Exchanger Recalled for Temperature Discrepancy

    Maquet is recalling 1,424 Plegiox Cardioplegia Heat Exchangers because they may fail to reach the desired cardioplegia temperature when used with a heater/cooler unit.

    Product
    MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1668-2014·2014-03-19

    Pecan Shed Recalls Candied Pecans Due to Undeclared Soy Allergen

    Pecan Shed is recalling Candied Pecans: Dark Chocolate because the product contains undeclared soy. The recall affects customers in nine states and Washington DC.

    Product
    Candied pecans: dark chocolate
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1169-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide