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.

20626–20650 of 50413

  • HighFDA (Devices)·Z-1390-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens is recalling 15 ADVIA 2120i automated hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare is recalling 674 ADVIA 2120i Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling ADVIA 2120 Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2021·2021-04-21

    Stryker PINPOINT Video Processor Recalled for Flickering and Reboots

    Stryker is recalling PINPOINT Video Processors/Illuminators that may flicker, lose image, or reboot unexpectedly.

    Product
    Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V277000·2021-04-21

    2022 Kia Carnival fuel rail defect increases fire risk

    2022 Kia Carnival vehicles may have damaged fuel rail tubes that could leak fuel, increasing the risk of fire. Kia will inspect and replace affected fuel rails free of charge.

    Product
    KIA — KIA CARNIVAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2021·2021-04-21

    Medline Stat-Site B-HB Diluent Recalled for Potential Test Inaccuracy

    Medline Industries is recalling Stat-Site B-HB Diluent because shipment compromise may cause false test results.

    Product
    Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21116·2021-04-21

    Brompton Recalls Electric Folding Bicycles Due to Software Malfunction Hazard

    Brompton Bicycle Inc. is recalling about 600 electric folding bicycles because a software malfunction can cause the motor to continue providing assistance when the rider is not pedaling, posing fall and injury hazards.

    Product
    Brompton Electric Folding Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling 32 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 572 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2021·2021-04-21

    FDA Recalls 59,828 Covidien Surgiwand II Suction and Irrigation Devices

    The FDA is recalling 59,828 units of the Covidien Surgiwand II Suction and Irrigation Device due to a manufacturing defect that generates particulate matter inside the tubing.

    Product
    Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1422-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1420-2021·2021-04-21

    Krishe Disposable Sampling Tubes Recalled for Missing Verification Data

    Krishe Inc is recalling 1.7 million disposable sampling tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1394-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 8 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V275000·2021-04-21

    Airstream Recalls 2020-2021 Interstates Due to Incorrect Weight Rating Label

    Airstream is recalling 2020-2021 Interstate vehicles because the Gross Vehicle Weight Rating label may list incorrect occupant cargo capacity, potentially leading to vehicle overload.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 43 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 185 ADVIA 2120i Dual Aspirate Autosamplers due to potential sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2021·2021-04-21

    Roche Recalls cobas SARS-CoV-2 and Influenza Assay Reagents

    Roche is recalling cobas SARS-CoV-2 & Influenza A/B assay reagents because they may produce invalid or false positive results.

    Product
    cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1398-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 195 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V272000·2021-04-21

    Airstream Recalls 2021 Interstate Coaches Due to Wiring Fire Risk

    Airstream is recalling 2021 Interstate touring coaches because an undersized radio wiring harness wire may melt, increasing the risk of a fire.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2021·2021-04-21

    VGlove Nitrile Examination Gloves Recalled for Containing Latex

    HUBO International is recalling VGlove Nitrile examination gloves because they contain latex instead of nitrile, posing a risk to latex-allergic individuals.

    Product
    VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1392-2021·2021-04-21

    Siemens ADVIA 2120i Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 283 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide