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.

21251–21275 of 50426

  • HighFDA (Food)·F-0217-2021·2021-01-27

    Khee Trading Recalls Frozen Tuna Ground Meat Due to Histamine Levels

    Khee Trading, Inc. is recalling 189 cartons of frozen tuna ground meat due to potential elevated levels of histamine. The product was distributed in Minnesota, California, New York, Illinois, and Texas.

    Product
    Frozen Tuna Ground Meat - Khee Trading Brand Product of Vietnam 22 Lb. Cartons (2 x 11 lb.)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0881-2021·2021-01-27

    Abbott i-STAT EG7+ Cartridges Recalled for Ionized Calcium Test Inaccuracy

    Abbott Point Of Care Inc. is recalling i-STAT EG7+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.

    Product
    Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2021·2021-01-27

    Boston Scientific Recalls Five ACUITY Universal Cutters Due to Sterilization Failure

    Boston Scientific is retrieving five ACUITY Universal Cutters that did not undergo the required sterile processing procedure.

    Product
    ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2021·2021-01-27

    Roche Cobas Infinity Software Error May Allow Unreliable Lab Results

    Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.

    Product
    A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0216-2021·2021-01-27

    JTM Food Group Recalls Macaroni and Cheese for Possible Metal Shavings

    JTM Provisions Co Inc is recalling JTM Food Group brand Ready to Eat White Cheddar Macaroni & Cheese due to possible metal shavings.

    Product
    JTM FOOD GROUP brand READY TO EAT WHITE CHEDDAR MACARONI & CHEESE in 5 lb. plastic bags, 6 bags per case.
    Category
    Food
    Distribution
    15 states
  • HighNHTSA·21V024000·2021-01-26

    2021 Subaru Outback CVT Select Lever Cable Defect Recall

    Subaru is recalling 2021 Outback and Impreza models due to an improperly tightened CVT select lever cable nut that may loosen, causing the gear selector to malfunction and increasing crash risk.

    Product
    SUBARU — SUBARU OUTBACK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V025000·2021-01-26

    Nissan Recalls 2020 INFINITI QX50 for Illegible Tire Placard

    Nissan is recalling 2020 INFINITI QX50 vehicles because the tire and loading information placard may be illegible, potentially leading to incorrect tire installation or overloading.

    Product
    INFINITI — INFINITI QX50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V022000·2021-01-21

    2021 Dutchmen Voltage recreational trailers recalled for mislabeled tire pressure

    Keystone RV Company is recalling 2021 Dutchmen Voltage trailers because the Federal Identification Tag incorrectly lists tire pressure as 95 PSI instead of 110 PSI, which could cause underinflated tires and increase crash risk.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V021000·2021-01-21

    2021 Dutchmen Voltage Recreational Trailers Recalled for Incorrect Tire Pressure Label

    Keystone RV Company is recalling 2020–2021 Dutchmen Voltage recreational trailers because the Federal Identification Tag lists incorrect tire pressure (110 PSI instead of 95 PSI), which could cause tire overinflation and increase crash risk.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2021·2021-01-20

    GE Healthcare Recalls Nuclear Medicine Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 52 nuclear medicine systems worldwide because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0841-2021·2021-01-20

    Fresenius Citrasate Liquid Acid concentrate drums recalled for conductivity deviation

    Fresenius Medical Care is recalling two drums of Citrasate Liquid Acid concentrate due to deviations in sodium conductivity and calcium concentration.

    Product
    Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2021·2021-01-20

    GE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Rotor Screws

    GE Healthcare is recalling 12 NM/CT 870 CZT systems because loose rotor bearing screws may cause a bearing to release.

    Product
    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0806-2021·2021-01-20

    Siemens Uroskop Omnia Max X-ray System Recalled for Support Arm Risk

    Siemens is recalling 281 Uroskop Omnia Max X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

    Product
    Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0268-2021·2021-01-20

    Western Mixers Trail Mix Recalled for Undeclared Cashews

    Western Mixers is recalling specific lots of Goody Goody Trail Mix in California due to undeclared cashews, a tree nut allergen.

    Product
    First Street Goody Goody Trail Mix 10 oz. (283g)S&F Item#52892 Unit UPC# 797565204201; First Street Goody Goody Trail Mix 16 oz. (454g) S&F Item#52651 Unit UPC# 797565204225; Western Mixers Goody Goody Trail Mix 10 oz. (283g) Unit UPC# 797565210363 Packed in clear…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0204-2021·2021-01-20

    Frozen Ground Tuna Recalled for Elevated Histamine Levels

    Ocean Providence Minneapolis LLC is recalling 790 lbs of frozen ground tuna due to elevated histamine levels. The product was distributed in five states.

    Product
    Frozen Ground Tuna, Wild Caught, Production Date: 06/01/2020. Product of Vietnam, Net Wt: 11 lbs. x 2: 22 lbs. Imported by Khee Trading, Inc., Compton, CA 90221 The ground tuna comes in a 22 lb. master carton that has two 11 lb. inner cartons. Inner cartons have 11 packs…
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0834-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Conductivity Deviation

    Fresenius Medical Care is recalling Citrasate Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.

    Product
    Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2021·2021-01-20

    GE Healthcare Recalls Discovery NM 630 and 830 Nuclear Medicine Cameras

    GE Healthcare is recalling 81 Discovery NM 630 and 830 units due to loose rotor bearing screws that could release a bearing.

    Product
    Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0232-2021·2021-01-20

    SAMYANG Buldak Hot Chicken Flavor Sauce Recalled for Undeclared Allergens

    Blue Stone Import USA Inc. is recalling SAMYANG Buldak Hot Chicken Flavor Sauce due to undeclared wheat, egg, and coconut oil.

    Product
    SAMYANG Buldak Hot Chicken Flavor Sauce - Carbonara, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0837-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2021·2021-01-20

    Siemens Atellica CH 930 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation

    Fresenius Medical Care is recalling 123 bottles of Naturalyte Liquid Acid concentrate due to conductivity deviations and low calcium levels.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2021·2021-01-20

    ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issue

    ICU Medical is recalling 220 Cogent Hemodynamic Monitoring Systems because a software issue may cause the display to show incorrect continuous cardiac output values after calibration.

    Product
    icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2021·2021-01-20

    GE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 24 NM/CT 850 systems because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0815-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide