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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16351–16375 of 27471

  • HighFDA (Devices)·Z-0776-2019·2019-02-13

    GE Healthcare Recalls Revolution CT Systems with SmartStep Option

    GE Healthcare is recalling 131 Revolution CT systems with the SmartStep Option because the displayed Z location may not match the actual table position, potentially causing scans at incorrect locations.

    Product
    Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2019·2019-02-13

    Handpiece Headquarters Recalls Henry Schein CU 1000 Halogen Curing Lights

    Handpiece Headquarters is recalling 252 Henry Schein CU 1000 Halogen Curing Lights because the tip became too hot, causing heat sensations in patients.

    Product
    Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2019·2019-02-13

    Smiths Medical Recalls Intermed 550 ml Sterile Water Humidifiers

    Smiths Medical is recalling Intermed 550 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2019·2019-02-13

    Smiths Medical Recalls Portex Normal Saline Units Due to Sterility Concerns

    Smiths Medical is recalling Portex Unit Dose 15 ml Normal Saline products because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex Unit Dose 15 ml Normal Saline ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 500 units of Double Diamond J Type Bone Marrow Needles due to a manufacturing defect in the sterile seal on blister trays.

    Product
    Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2019·2019-02-13

    Angiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 180 units of J Type Bone Marrow Needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2019·2019-02-13

    GE Healthcare Recalls Centricity Universal Viewer Breast Imaging Software

    GE Healthcare is recalling Centricity Universal Viewer Breast Imaging software because a display error could lead to incorrect patient diagnoses.

    Product
    GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0765-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

    Edwards Lifesciences is recalling 459 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings, potentially leading to misdiagnosis.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0764-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

    Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0767-2019·2019-02-06

    West Pharma Vial2BAG DC 13mm Recalled for Adverse Events

    West Pharma Services IL, Ltd. is recalling Vial2BAG DC 13mm devices due to reported adverse events and potential inadequate drug admixing.

    Product
    Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0763-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

    Edwards Lifesciences is recalling 875 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0784-2019·2019-02-06

    Roche Anti-HAV IgM Test System Recalled for Erroneous Results

    Roche Diagnostics is recalling Anti-HAV IgM test systems due to potential erroneous result messages on the cobas e 602 module.

    Product
    Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2019·2019-02-06

    Medtronic Recalls Reservoir Y Adapters Due to Tearing and Cracking

    Medtronic is recalling 1,100 Reservoir Y Adapters because the Y-connectors may tear or crack, potentially causing blood loss and circuit breaches during autotransfusion.

    Product
    RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2019·2019-02-06

    XTant Medical Recalls Calix Lumbar Spinal Implants for Sterilization Concerns

    XTant Medical is recalling 632 Calix Lumbar Spinal Implant System units due to a change in packaging and sterilization method to address potential risks of compromised sterilization.

    Product
    Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0779-2019·2019-02-06

    Haemonetics Recalls Cell Saver Elite Processing Kits Due to Leakage Risk

    Haemonetics is recalling 4,576 Cell Saver Elite Processing Kits because the 70ml centrifuge bowl may leak during cell salvage processing.

    Product
    Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2019·2019-02-06

    West Pharma Services Recalls Vial2BAG DC 20mm Medical Devices

    West Pharma Services is recalling Vial2BAG DC 20mm devices because adverse events were reported with the similar 13mm model used with oxytocin in pregnant women.

    Product
    Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0788-2019·2019-02-06

    GE Healthcare Recalls LOGIQ P6 Ultrasound Scanners Due to Probe Heating

    GE Healthcare is recalling 1,897 LOGIQ P6 ultrasound scanners (Models BT07 and BT09) because the probe-head surface can reach increased temperatures during specific scans.

    Product
    GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0768-2019·2019-02-06

    FDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events

    West Pharma Services is recalling Vial2BAG Transfer Devices because adverse events were reported when used with oxytocin in pregnant women.

    Product
    Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0786-2019·2019-02-06

    Medtronic Recalls Suction and Anticoagulation Assemblies Due to Connector Defects

    Medtronic is recalling 7,587 Suction and Anticoagulation Assemblies because Y-connectors may tear or crack, potentially causing leaks and blood loss.

    Product
    SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2019·2019-02-06

    Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues

    Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.

    Product
    Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing.

    Product
    Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2019·2019-02-06

    3M Surgical Clipper Recalled for Overheating Risk During Charging

    3M is recalling 19,860 Surgical Clippers due to reports of overheating when charging from modified sine wave power inverters in mobile EMS settings.

    Product
    3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0778-2019·2019-02-06

    Haemonetics Recalls Cell Saver 5/5+ Bowl Sets Due to Leakage

    Haemonetics is recalling 11,208 units of Cell Saver 5/5+ Bowl Sets because the 70ml centrifuge bowls may leak during cell salvage processing.

    Product
    Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.

    Product
    Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various…
    Category
    Medical Device
    Distribution
    Distributed nationwide