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 deaths or serious injuries are reported, 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.

Filters

Agency

Category

Minimum severity

Clear filters

12576–12600 of 13802

  • HighFDA (Devices)·Z-0241-2022·2021-12-01

    Philips CombiDiagnost R90 X-ray systems missing required radiation warning labels

    Philips Healthcare is recalling CombiDiagnost R90 X-ray systems because some units lack required FDA radiation warning labels and X-ray certification statements. No injuries have been reported.

    Product
    CombiDiagnost R90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2022·2021-12-01

    Clinical Chemistry Analyzer Software Defects May Produce Inaccurate Results

    Abbott ARCHITECT clinical chemistry analyzers with software 9.41 and earlier contain defects affecting calibration, sample handling, and quality control that may produce inaccurate diagnostic results.

    Product
    ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0289-2022·2021-12-01

    CT Scanner Software May Cause Workflow Delays and Patient Rescans

    Siemens SOMATOM Edge Plus CT scanners with syngo.CT VB20 software may experience workflow interruptions, potentially delaying diagnoses and requiring patient rescans. The issue affects 64 units nationwide.

    Product
    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2022·2021-12-01

    Freelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy

    The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.

    Product
    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0283-2022·2021-12-01

    CT Scanner Software Issue May Interrupt Diagnostic Workflows and Delay Diagnoses

    Siemens SOMATOM Force CT scanners with software syngo.CT VB20 may experience workflow interruptions, causing diagnosis delays and requiring additional patient scans and contrast media. No illnesses or injuries have been reported.

    Product
    SOMATOM Force with software syngo.CT VB20 Model #10742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2022·2021-12-01

    Medical imaging device missing required radiation safety labels

    Philips Healthcare is recalling DigitalDiagnost C90 medical imaging devices because some units lack required radiation warning labels and X-ray certification statements. Affected customers should contact Philips to have the missing labels applied.

    Product
    DigitalDiagnost C90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2022·2021-12-01

    CT imaging system ceiling mount bracket shaft wear may cause equipment to fall

    A CT fluoroscopy imaging system ceiling mount's bracket shaft may wear excessively and go undetected, potentially causing the bracket to detach and fall, risking injury to patients, operators, or service personnel.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2022·2021-12-01

    Ocean Water Seal Chest Drain Recalled for Inadequate Setup Instructions

    Atrium Medical is recalling 87,972 Ocean Water Seal Chest Drains due to inadequate setup instructions that may result in treatment delays and risk of patient harm.

    Product
    The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chambe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2022·2021-12-01

    Philips CT Fluoroscopy Ceiling Mount Bracket Wear and Detachment Hazard

    Philips Continuous CT Fluoroscopy ceiling mounts may experience monitor bracket assembly wear that goes undetected, potentially causing the bracket to detach and fall on patients, operators, or bystanders during surgery.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2022·2021-12-01

    Western Oxytote VIPR System Battery Rupture Risk with Fume Emission

    Western/Scott Fetzer Company is recalling 40 units of the Western Oxytote DTE Digital VIPR System due to battery rupture risk that can break the plastic shroud and release fumes and smoke.

    Product
    Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0285-2022·2021-12-01

    Siemens CT Scanner Software May Cause Diagnostic Workflow Delays

    Siemens SOMATOM Definition Edge CT scanners with syngo.CT VB20 software may experience workflow interruptions, causing diagnostic delays, need for repeat scans, and additional contrast media use. 298 units nationwide are affected.

    Product
    SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2022·2021-12-01

    PET/CT Imaging System Ceiling Mount May Detach Due to Bracket Wear

    Philips TruFlight Select PET/CT imaging systems have a Monitor Bracket Assembly that may detach from the ceiling mount due to undetected shaft wear, posing a risk of injury to patients, staff, and bystanders.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2022·2021-12-01

    BD Nexiva IV Catheters Recalled Due to Non-Sterile Packaging Breach

    Becton Dickinson is recalling BD Nexiva IV catheter systems because of a packaging breach that renders them non-sterile. The recall affects 155,840 devices distributed nationwide.

    Product
    BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0269-2022·2021-12-01

    FDA Recalls Western Oxytote DTE Digital VIPR System Due to Battery Rupture Risk

    Western/Scott Fetzer Company is recalling 40 units of the Oxytote DTE Digital VIPR System due to battery rupture risk. The device may emit fumes and smoke when the battery ruptures and plastic shroud breaks apart.

    Product
    Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0276-2022·2021-12-01

    Diagnostic thromboplastin reagent recalled due to performance issues

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.

    Product
    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0271-2022·2021-12-01

    Abbott ARCHITECT Analyzer Software Issues May Cause Inaccurate Test Results

    Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.

    Product
    ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0288-2022·2021-12-01

    Siemens SOMATOM Confidence CT Scanners Recalled for Software-Related Workflow Interruptions

    Siemens SOMATOM Confidence CT scanners may experience software-related workflow interruptions that could delay patient diagnosis. The recall affects 104 units nationwide; affected facilities should contact the manufacturer for remediation instructions.

    Product
    SOMATOM Confidence with software syngo.CT VB20 Model #10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2022·2021-12-01

    CT Scanner Software May Cause Workflow Interruptions and Diagnosis Delays

    Siemens SOMATOM Drive CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnosis and require additional patient scans. Approximately 75 units are affected nationwide.

    Product
    SOMATOM Drive with software syngo.CT VB20 Model #10431700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2022·2021-12-01

    Medtronic Endurant IIs stent graft recalled due to spindle detachment risk

    Medtronic recalls 419 Endurant IIs stent grafts due to risk of spindle detachment from the hypotube during deployment.

    Product
    Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2022·2021-12-01

    Imaging device ceiling mount assembly may detach, posing injury risk

    A ceiling-mounted component on Philips CT imaging equipment may detach due to wear. This poses a risk of injury to patients, operators, or staff in operating rooms.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2022·2021-12-01

    Continuous CT Fluoroscopy Ceiling Mount Bracket Assembly Wear Recall

    Monitor bracket assemblies in Philips Continuous CT Fluoroscopy systems may experience significant wear and detach, potentially injuring patients, operators, or bystanders during surgical procedures.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2022·2021-12-01

    Medical X-Ray Systems Missing Required Radiation Warning Labels

    Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.

    Product
    ProxiDiagnost N90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0305-2022·2021-12-01

    Siemens Artis Q.zen Angiography System X-Ray Imaging Delay Issue

    Siemens has recalled two Artis Q.zen angiography systems due to a software issue that may prevent x-ray imaging and delay procedures when SID lift and x-ray controls are activated simultaneously.

    Product
    Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2022·2021-12-01

    Siemens Artis Zee Biplane X-ray Imaging System Software Malfunction

    Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, resulting in procedural delays.

    Product
    Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2022·2021-12-01

    Siemens Artis zee x-ray system may delay imaging delivery during procedures

    Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.

    Product
    Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide