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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15401–15425 of 27500

  • HighFDA (Devices)·Z-2272-2019·2019-08-21

    Siemens SOMATOM Confidence CT Systems Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling SOMATOM Confidence CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2019·2019-08-21

    Siemens CT Systems Recalled for Software Issues Causing Scan Aborts

    Siemens is recalling SOMATOM Definition Edge CT systems due to four safety-related software issues in syngo.CT version VB10A that may result in scan aborts.

    Product
    SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2019·2019-08-21

    BD Vacutainer Fluoride Tubes Recalled Due to Missing Preservative Additive

    Becton Dickinson is recalling 247,000 blood alcohol test tubes because they lack the required fluoride additive, which may cause inaccurate test results if samples are stored for more than two days.

    Product
    BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2019·2019-08-21

    Siemens SOMATOM Force CT Systems Recalled for Software Scan Abort Issues

    Siemens Medical Solutions is recalling SOMATOM Force CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x105 (Item 19669) due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2019·2019-08-21

    Pega Medical Recalls SLIM Handle Components Due to Jamming Risk

    Pega Medical Inc. is recalling 19 SLIM Handle components because an internal ring may detach, causing the handle to jam with the driver.

    Product
    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2249-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x95 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2019·2019-08-21

    Luminex ARIES Flu A/B & RSV Assay Recalled for Seal Defects

    Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.

    Product
    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2275-2019·2019-08-21

    NeuroLogica HS70A Ultrasound Systems Recalled for Probe Overheating Risk

    NeuroLogica is recalling HS70A Diagnostic Ultrasound Systems due to a potential risk of probes overheating when users decrease the Doppler Sample Volume size in Doppler Only mode.

    Product
    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2019·2019-08-21

    BioPro K-Wire HBS Sterile Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x38 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2276-2019·2019-08-21

    NeuroLogica WS80A Diagnostic Ultrasound System Recalled for Probe Overheating Risk

    NeuroLogica is recalling WS80A Diagnostic Ultrasound Systems because probes may overheat when users decrease the Doppler Sample Volume size in Doppler Only mode.

    Product
    WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2073-2019·2019-08-14

    St Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2072-2019·2019-08-14

    St Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures

    St Jude Medical is recalling 52 Ellipse VR cardioverter defibrillators worldwide due to damaged aluminum wires that may prevent high-voltage therapy delivery.

    Product
    ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2019·2019-08-14

    Ad-Tech Recalls Non-Sterile Anchor Bolts for Depth Electrodes

    Ad-Tech Medical Instrument Corporation is recalling 201 non-sterile anchor bolts distributed without regulatory clearance or validated sterilization instructions.

    Product
    LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2168-2019·2019-08-14

    Centurion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns

    Centurion Medical Products Corporation is recalling 192 High Drainage LVAD Tray Kits because sterile packaging may be compromised.

    Product
    HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2075-2019·2019-08-14

    St Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators

    St Jude Medical is recalling 42 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.

    Product
    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2019·2019-08-14

    Intellijoint G2 Workstation Recalled Due to MacBook Pro Fire Risk

    Intellijoint Surgical is recalling 23 G2 Workstations because the Apple MacBook Pro components may overheat and pose a fire safety risk.

    Product
    Workstation, G2, Configured (P/N 000-0241)
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2219-2019·2019-08-14

    Ideal Implant Recalls Structured Saline Breast Implants Due to Deflation

    Ideal Implant Incorporated is recalling 1,704 structured saline breast implants because a silicone piece disrupted the valve seal, causing deflation shortly after implantation.

    Product
    IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2070-2019·2019-08-14

    St Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 27 Ellipse VR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2071-2019·2019-08-14

    St Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 47 Ellipse VR ICDs worldwide due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2019·2019-08-14

    SenTec Membrane Changer Set Recalled for Potential Electrolyte Application Failure

    SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2019·2019-08-14

    Comet Technologies Recalls YXLON Cougar Cabinet X-Ray Systems

    Comet Technologies is recalling 93 YXLON Cougar Cabinet X-Ray Systems because the door interlocks fail to meet federal performance standards for power disconnection.

    Product
    YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2019·2019-08-14

    MED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures

    MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.

    Product
    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant…
    Category
    Medical Device
    Distribution
    Distributed nationwide