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.

21276–21300 of 50426

  • HighFDA (Devices)·Z-0811-2021·2021-01-20

    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 08-1251-1 - 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-0823-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling 51 drums of NaturaLyte Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - 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 (Food)·F-0231-2021·2021-01-20

    SAMYANG Hot Chicken Flavor Sauce Recalled for Undeclared Allergens

    BLUE STONE IMPORT USA INC is recalling SAMYANG Hot Chicken Flavor Sauce because it contains undeclared wheat, egg, and milk.

    Product
    SAMYANG Buldak Hot Chicken Flavor Sauce - Extremely Spicy, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0863-2021·2021-01-20

    Siemens Atellica IM 1600 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - 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-0843-2021·2021-01-20

    Medtronic CareLink Diabetes Software Recalled for Data Transfer Errors

    Medtronic is recalling CareLink Personal and System software due to potential RF interference during data uploads, which may cause incomplete basal rate information and inappropriate therapy changes.

    Product
    CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2021·2021-01-20

    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 08-1301-4 - 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
  • HighNHTSA·21V018000·2021-01-20

    2021 Western Star and Freightliner trucks recalled for brake caliper mounting defect

    Commercial trucks from multiple manufacturers may have incorrectly tightened brake caliper mounting bolts, reducing braking effectiveness. Daimler Trucks North America will notify owners for free inspection and repair.

    Product
    FCCC — FCCC, FREIGHTLINER, WESTERN STAR XCP, XCS, XCL, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2021·2021-01-20

    GE Healthcare Recalls Optima NM/CT 640 Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling seven Optima NM/CT 640 units because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    Optima NM/CT 640, Model number 3101RL - 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-0846-2021·2021-01-20

    Roche cobas z 480 Analyzer Recalled for Dirty Lens Risk

    Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.

    Product
    The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2021·2021-01-20

    GE Healthcare Recalls 12 NM/CT 860 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 12 NM/CT 860 systems because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    GE NM/CT 860 system Model Number H3908AD - 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-0827-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Low Sodium and Calcium Levels

    Fresenius Medical Care is recalling 548 cases of Citrasate Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-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-0833-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

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

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 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
  • HighFDA (Devices)·Z-0835-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation

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

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - 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 (Food)·F-0206-2021·2021-01-20

    Netuno Caribbean Red Snapper Recalled for Potential Salmonella Contamination

    Netuno USA, Inc. is recalling 500 cases of Caribbean Red Snapper due to potential Salmonella contamination. The product was distributed in Puerto Rico.

    Product
    NETUNO Caribbean Red Snapper, Net Weight 10 Lbs (4.54 Kg), Item 101229, Product Must be Fully Cooked Prior to Consumption, 1.5-2.0 LB
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0862-2021·2021-01-20

    Siemens Atellica IM 1300 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.23.2 or lower because the software may report discrepant patient results.

    Product
    Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - 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-0826-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

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

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - 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-0809-2021·2021-01-20

    Cook Medical Recalls Disposable Humidification Flasks Due to Stopper Defect

    Cook Medical is recalling 56,250 Disposable Humidification Flasks because a manufacturing defect may cause silicone stoppers to dislodge or gas to leak, impeding gas flow to incubation chambers.

    Product
    Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V015000·2021-01-20

    2021 Keystone Crossroads Redwood Recreational Trailers U-bolt Suspension Recall

    Keystone RV Company is recalling certain 2021 Crossroads Redwood recreational trailers because U-bolts on the rear axles may have been improperly torqued, causing them to loosen and the axle to shift, which increases crash risk.

    Product
    KEYSTONE — KEYSTONE CROSSROADS REDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2021·2021-01-20

    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 08-3231-1 - 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 (Food)·F-0230-2021·2021-01-20

    SAMYANG Buldak Hot Chicken Flavor Sauce Recalled for Undeclared Allergens

    Blue Stone Import USA Inc. is recalling SAMYANG Buldak Hot Chicken Flavor Sauce because it contains undeclared wheat, egg, and milk.

    Product
    SAMYANG Buldak Hot Chicken Flavor Sauce, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0822-2021·2021-01-20

    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 08-4231-0 - 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
  • HighFDA (Devices)·Z-0818-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium and Calcium 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 08-3201-4 - 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-0821-2021·2021-01-20

    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 08-3301-2 - 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-0805-2021·2021-01-20

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

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

    Product
    Uroskop Omnia, Model no. 10094910 - 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