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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13851–13875 of 27471

  • 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
  • HighFDA (Devices)·Z-1808-2020·2020-05-06

    Uromedica Recalls ProACT Implantation Instrument Sets Due to Sheath Defects

    Uromedica Inc. is recalling 11 ProACT Implantation Instrument Sets because defective U-channel sheaths may damage ProACT implant devices during use.

    Product
    ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2020·2020-05-06

    GE Healthcare Recalls Lunar iDXA Bone Densitometers Due to Radiation Risk

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

    Product
    Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2020·2020-05-06

    Kerr Nexus Universal Trial Kits Recalled for Incorrect Bonding Agent

    Kerr/Pentron is recalling 111 trial kits of Nexus Universal with OptiBond Universal due to a packaging error that included the incorrect bonding agent, potentially increasing the risk of bond failures.

    Product
    Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2020·2020-05-06

    Beckman Coulter Recalls Barbiturates Reagent Due to Potential Test Inaccuracy

    Beckman Coulter is recalling SYNCHRON Systems Barbiturates Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative results.

    Product
    SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2020·2020-05-06

    Welch Allyn Surveyor S12 and S19 Patient Monitors Recalled for Defibrillation Safety

    Welch Allyn is recalling 78,521 Surveyor S12 and S19 bedside monitors and patient cables because they may not meet defibrillation withstand safety requirements.

    Product
    Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2020·2020-05-06

    ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues

    ICU Medical is recalling 83 Cogent Hemodynamic Monitoring Systems due to software issues that may cause inaccurate data, unit shutdown, or loss of display.

    Product
    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2020·2020-05-06

    Capso Vision Recalls CapsoCAM Plus Capsule Endoscopy Systems

    Capso Vision is recalling 1,882 CapsoCAM Plus capsule endoscopy systems because a defect in the capsule window may cause the housing to crack and leak during use.

    Product
    CapsoCAM Plus, UDI: 00867770000209
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1818-2020·2020-05-06

    Welch Allyn Q-Tel RMS System Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling 78,521 Q-Tel RMS systems because they may not meet defibrillation withstand safety requirements.

    Product
    Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2020·2020-05-06

    GE Healthcare Recalls Lunar iDXA Bone Densitometers Due to Radiation Risk

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

    Product
    Lunar iDXA bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide