The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

14826–14850 of 40112

  • ModerateFDA (Devices)·Z-1438-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Labeling Correction

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HVAD System to correct inaccurate descriptions of controller connection verification.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1426-2021·2021-04-28

    HeartWare HVAD System Manual Updates for Carrying Cases and Driveline Cover

    Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1384-2021·2021-04-21

    Recall of Covidien Signia Vascular Stapler Reloads Due to Safety Interlock Failure

    FDA recalls 11,391 units of Covidien Signia vascular stapler reloads because a safety interlock may fail, allowing empty reloads to fire and cause tissue injury.

    Product
    Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2021·2021-04-21

    Roche cobas Liat Analyzer Respiratory Virus Panel Recall

    Roche is recalling the cobas Liat Analyzer respiratory virus panel due to invalid or false positive results for SARS-CoV-2 and Influenza A/B.

    Product
    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1383-2021·2021-04-21

    FDA Recalls Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired and causing tissue injury.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1385-2021·2021-04-21

    Recall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1410-2021·2021-04-21

    K2M Chesapeake Cervical Drill Guide Inserter Recalled for Interference Defect

    K2M, Inc. is recalling the Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to an interference condition that may cause spinal cord injury or screw misalignment.

    Product
    Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1396-2021·2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 132 ADVIA 2120 hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 187 ADVIA 2120i Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 7 ADVIA 2120 automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • 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
  • 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