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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13401–13425 of 27500

  • HighFDA (Devices)·Z-2433-2020·2020-07-08

    Codan Swan-Lock Needlefree Connectors Recalled for Potential Sterility Compromise

    Codan US Corporation is recalling 34,776 units of Swan-Lock Swabable Needlefree Connectors because individual packages may have incomplete or bad seals that could compromise sterility.

    Product
    CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2442-2020·2020-07-08

    Elekta Leksell Vantage Stereotactic System Recall for Locking Mechanism Defect

    Elekta is recalling 51 Leksell Vantage Stereotactic Systems because the locking mechanism at the Instrument Carrier and Arc interface may not function properly.

    Product
    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2437-2020·2020-07-08

    Siemens CentraLink Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to a defect that may cause erroneous patient results.

    Product
    (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2410-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2443-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 120 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2479-2020·2020-07-08

    Preventice BodyGuardian Heart Remote Monitoring Kit Recalled for Data Accuracy Issues

    Preventice Services is recalling eight BodyGuardian Heart Remote Monitoring Kits because unvalidated software may cause inaccurate data collection, making patient reports unreliable for condition evaluation.

    Product
    BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2020·2020-07-08

    Radiometer ABL80-FLEX CO-OX Box Label Recall for Barcode Misinterpretation

    Radiometer Medical ApS is recalling ABL80-FLEX CO-OX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

    Product
    ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2474-2020·2020-07-08

    Baxter GEM Flow Coupler Monitor Recalled for Firmware Shutdown Issue

    Baxter Healthcare is recalling 60 units of the GEM Flow Coupler Monitor because a firmware issue may cause intermittent shutdowns when WiFi is not connected.

    Product
    Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2458-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 20 units of Sterile Standalone Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2447-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile standalone connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2470-2020·2020-07-08

    Siemens IMMULITE 2000 XPi Analyzer Recalled for Tubing Crack Risk

    Siemens Healthcare Diagnostics Inc. is recalling 2,925 IMMULITE 2000 XPi Immunoassay Systems because flexible tubing can crack, causing liquid waste leaks and slip hazards.

    Product
    Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2020·2020-07-08

    Siemens IMMULITE 2000 Analyzer Recalled for Tubing Crack Hazard

    Siemens Healthcare Diagnostics is recalling 1,555 IMMULITE 2000 analyzers because flexible tubing can crack, causing liquid waste leaks and slip hazards.

    Product
    Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2460-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors because internal tests identified a potential breach in the sterile barrier.

    Product
    3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2452-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2457-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 240 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2461-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 420 units of sterile standalone connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2416-2020·2020-07-08

    Arrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2438-2020·2020-07-08

    Siemens Atellica Data Manager Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling Atellica Data Manager software versions 1.0 and 1.1 because unexpected interface driver behavior may cause quality control results to be assigned to incorrect control lot numbers, potentially leading to the reporting of erroneous patient results.

    Product
    (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2449-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 648 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2471-2020·2020-07-08

    Fujifilm Synapse PACS Software Recalled for Incorrect Orientation Markers

    Fujifilm is recalling Synapse PACS Software versions 5.5.x and 5.7.x because incorrect orientation markers and slice locations may lead to misdiagnosis.

    Product
    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2448-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2473-2020·2020-07-08

    Elekta Unity Radiation Therapy System Recalled for Heating Issues

    Elekta, Inc. is recalling 21 Unity Image-Guided Radiation Therapy Systems due to reports of excessive heating in the MRL Gradient Connection Module.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System
    Category
    Medical Device
    Distribution
    3 states