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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13826–13850 of 27500

  • HighFDA (Devices)·Z-1879-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2020·2020-05-13

    Varian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure

    Varian Medical Systems is recalling 151 Multileaf Collimators because a software upgrade caused leaves to fail to move during specific arc treatments.

    Product
    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a manufacturing programming error prevents the system from correctly measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2020·2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 332 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process. The recall covers lots Y47472 and Z000V0 distributed nationwide.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2020·2020-05-13

    Inpeco Centrifuge Module Recall for Potential Unbalanced Load Damage

    Inpeco S.A. is recalling 23 Abbott Accelerator a3600 Centrifuge Modules because a loading algorithm defect may cause unbalanced loads that could damage the equipment.

    Product
    Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1864-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 25 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1919-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 275 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.

    Product
    REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1923-2020·2020-05-13

    Philips Brilliance IQon Spectral CT Recall for Cooling Unit Bolt Issue

    Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.

    Product
    Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1905-2020·2020-05-13

    Medtronic Recalls Visualase Cooled Laser Applicator System Tubing Sets

    Medtronic is recalling Visualase Cooled Laser Applicator System tubing sets due to assembly defects that may disrupt saline flow.

    Product
    Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1903-2020·2020-05-13

    Ortho Development Recalls Tibial Tray Due to Manufacturing Defect

    Ortho Development Corporation is recalling 27 units of Tibial Tray Nonporous A Size 2 due to a manufacturing defect in the locking mechanism that may cause assembly resistance.

    Product
    Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1906-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci SP Instrument Arm Drapes

    Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because they may tear, compromising the sterile barrier.

    Product
    da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-1806-2020·2020-05-06

    Philips TraumaDiagnost X-Ray System Recalled Due to Potential Shaft Failure

    Philips North America is recalling 346 TraumaDiagnost X-Ray systems because a shaft may break due to material fatigue, causing the arm to fall and potentially injure patients or staff.

    Product
    Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2020·2020-05-06

    Radiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect

    Radiometer Medical ApS is recalling two ABL800 FLEX analyzers in California due to a power supply defect that may cause treatment delays and serious health risks.

    Product
    ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1825-2020·2020-05-06

    Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery

    Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.

    Product
    Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2020·2020-05-06

    Welch Allyn X12+ Telemeter and Patient Cable Recall for Defibrillation Safety

    Welch Allyn is recalling X12+ Telemeters and patient cables because they may not meet defibrillation withstand requirements.

    Product
    X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2020·2020-05-06

    Philips Azurion 7 M20 XperGuide Software Recall for Incorrect Overlay Display

    Philips is recalling Azurion 7 M20 systems with XperGuide software because a software defect may display incorrect needle paths if the L-arm is mispositioned.

    Product
    Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1821-2020·2020-05-06

    Alcon Air Optix Night & Day Aqua Contact Lenses Recalled for Counterfeit Concerns

    Allied Vision Group is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because potentially counterfeit products and packaging were imported to the U.S.

    Product
    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2020·2020-05-06

    Stryker Recalls 90 Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling

    Stryker Sustainability Solutions is recalling 90 reprocessed Zimmer tourniquet cuffs because they are potentially mislabeled. The mislabeling could lead to device misuse or inadequate limb compression during surgery.

    Product
    Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2020·2020-05-06

    Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

    Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.

    Product
    Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2020·2020-05-06

    Philips Azurion 7 M20 X-Ray System Recalled for Loose Screw Risk

    Philips is recalling 162 Azurion 7 M20 angiographic X-ray systems because unspecified torque on C-arm roll motor screws could cause them to become loose.

    Product
    Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2020·2020-05-06

    GE Healthcare Recalls Lunar iDXA Advance Bone Densitometers Due to Radiation Risk

    GE Healthcare is recalling 123 Lunar iDXA Advance bone densitometers because a control panel issue may cause the start button to stick, potentially leading to accidental radiation exposure.

    Product
    Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2020·2020-05-06

    ViewRay MRIdian TPDS Software Recalled for Dose Alignment Errors

    Viewray, Inc. is recalling 32 units of MRIdian TPDS software due to a defect that may cause incorrect dose calculations during treatment planning.

    Product
    ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1811-2020·2020-05-06

    Welch Allyn ELI PC Service Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling ELI PC Service software because it may not meet defibrillation withstand safety requirements for medical electrical equipment.

    Product
    ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
    Category
    Medical Device
    Distribution
    Distributed nationwide