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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20101–20125 of 40248

  • HighFDA (Devices)·Z-2118-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Kilts Due to Inadequate Shielding

    Burlington Medical is recalling 37 radiation protection kilts because the protective material may provide inadequate shielding against scatter radiation.

    Product
    Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2056-2019·2019-08-07

    Agfa DR 800 Digital Radiography System Recalled for Image Mismatch

    Agfa N.V. is recalling four DR 800 digital radiography systems because the exposed area of fluoroscopic exams may not match the active detector area.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2019·2019-08-07

    A&E Medical Ultra-Flex Pacing Wire Recalled for Instruction Updates

    Alto Development Corp is recalling Ultra-Flex MYO/Wire pacing wires to update instructions for use to ensure consistency with the M-21 loop electrode.

    Product
    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2019·2019-08-07

    Philips Recalls Azurion X-ray Systems Due to Software Defect

    Philips is recalling 229 Azurion Interventional Fluoroscopic X-ray Systems because a software defect may cause radiation levels too low for diagnostic images.

    Product
    Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2134-2019·2019-08-07

    Hycor Biomedical Recalls AUTOSTAT II IgM Rheumatoid Factor Test Kits

    Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.

    Product
    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2133-2019·2019-08-07

    Xhale Assurance Nasal SpO2 Sensor Recall for Missing Instructions

    Xhale Assurance is recalling 701,272 Nasal Alar SpO2 Sensors because the Instructions for Use are missing steps for checking and changing the application site.

    Product
    Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2058-2019·2019-07-31

    Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect

    Zyno Medical LLC is recalling administration sets with inverted pinch clamps that may cause blood to be drawn from patients instead of delivering fluid.

    Product
    Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2081-2019·2019-07-31

    GammaPod Stereotactic Radiotherapy System Recalled for Alignment Drift

    Xcision Medical Systems is recalling two GammaPod Stereotactic Radiotherapy Systems because a loose bolt caused alignment drift and reduced radiation dose output.

    Product
    GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2011-2019·2019-07-31

    Philips BrightView XCT Medical Device Recalled for Handcontroller Motion Defect

    Philips Medical Systems is recalling 427 BrightView XCT devices because a handcontroller issue may cause uncommanded motions or continued motion after buttons are released.

    Product
    BrightView XCT , Model Number 882482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2019·2019-07-31

    GE Healthcare Recalls MAC VU360 Electrocardiographs Due to Patient ID Errors

    GE Healthcare is recalling 369 MAC VU360 electrocardiographs because they may display incorrect patient IDs or demographics, potentially assigning ECG reports to the wrong patient.

    Product
    MAC VU360, Model Number 2030360-001, Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2026-2019·2019-07-31

    Siemens AXIOM Artis TC X-ray Generator Recall for Power Supply Issue

    Siemens is recalling one AXIOM Artis TC unit due to a power supply tolerance issue that may cause X-ray generation failure during procedures.

    Product
    AXIOM Artis TC, Model Number 7728350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2019·2019-07-31

    Bard Nautilus Delta Port Kits Recalled for ECG Signal Loss

    Bard Peripheral Vascular is recalling specific Nautilus Delta Port Kits due to a risk of losing the intravascular ECG signal during placement procedures.

    Product
    POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect

    Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2019·2019-07-31

    InfuTronix Nimbus Administration Set Recalled for Potential Tube Leakage

    InfuTronix LLC is recalling Nimbus Administration Sets due to a potential for tube leakage. The recall affects 10,800 units distributed in Massachusetts.

    Product
    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2025-2019·2019-07-31

    Siemens AXIOM Artis dFC X-ray Generator Recall for Power Supply Issue

    Siemens is recalling 19 AXIOM Artis dFC units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.

    Product
    AXIOM Artis dFC, Model Number 7727717
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2019·2019-07-31

    Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect

    Zyno Medical LLC is recalling administration sets where an inverted pinch clamp may cause blood to be drawn from the patient instead of delivering fluid.

    Product
    Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2035-2019·2019-07-31

    Spacelabs Smart Disclosure System Recalled for Patient Data Mismatch

    Spacelabs Healthcare is recalling the Smart Disclosure System because patient records were printed with waveforms from other patients.

    Product
    Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 844,000 Sur-vet Needles because a loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2042-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2053-2019·2019-07-31

    MOOG Curlin Infusion Administration Set Recalled for Filter Leaks

    Zevex Incorporated is recalling MOOG Curlin Infusion Administration Sets because they leaked at the filter. The affected sterile sets were distributed to six US states.

    Product
    MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2041-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns

    Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 563,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
    Category
    Medical Device
    Distribution
    12 states