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.

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12701–12725 of 13837

  • SevereFDA (Devices)·Z-0194-2022·2021-11-10

    IPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination

    Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.

    Product
    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0119-2022·2021-11-10

    Monoject Prefilled Syringe Plunger Defect Recall: Air Reintroduction Risk

    Monoject prefilled syringes in medical kits may have a plunger that rebounds after air expulsion, potentially reintroducing air into the syringe. This FDA Class I recall affects approximately 9,378 units distributed in Florida and Pennsylvania.

    Product
    Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Sp
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0193-2022·2021-11-10

    Siemens Aptio Interface Module may misassociate laboratory test results

    Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.

    Product
    Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0199-2022·2021-11-10

    MEDRAD Twist & Go Syringe Recalled Due to Labeling Error

    Bayer Medical Care is recalling 6,950 units of MEDRAD Twist & Go Disposable Syringes due to labeling errors that could cause confusion about syringe compatibility with the MEDRAD Mark 7 Arterion Injection System.

    Product
    The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2022·2021-11-10

    Dental implant recalled due to size mismatch with labeling

    Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.

    Product
    ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2022·2021-11-10

    Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band

    Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.

    Product
    Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0187-2022·2021-11-10

    COVENA PICC Sleeve Recalled for Unauthorized FDA Marketing

    Queen Comfort Products is recalling the COVENA PICC Sleeve, marketed without FDA clearance. Patients currently using the device should contact their healthcare provider immediately.

    Product
    COVENA PICC Sleeve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2022·2021-11-10

    Arietta 850 Ultrasound Software Displays Cardiology Measurements Incorrectly

    FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.

    Product
    Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2022·2021-11-10

    Flexible Intubation Videoscope Recall Due to Sterility Assurance Failure

    Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.

    Product
    FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0200-2022·2021-11-10

    Artis zeego X-Ray System Software Error Affects Image Reconstruction

    Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.

    Product
    Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2022·2021-11-10

    Arietta 65 Ultrasound Software: Calculation Error in EROA Diagnostic Measurements

    Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.

    Product
    Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2022·2021-11-10

    Lisendo 880 Ultrasound Software displays incorrect cardiac valve measurements

    Lisendo 880 Ultrasound Software versions V1.0–V4.1.3 may not display cardiac measurement results correctly for mitral valve assessments, affecting diagnostic accuracy.

    Product
    Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2022·2021-11-10

    Dental Implants Mislabeled as Smaller Size; Risk of Nerve Damage

    GM Helix Acqua Implant dental implants were mislabeled as a smaller size. If incorrectly installed in cases with low bone quality, they could damage the nerve or adjacent bone structures.

    Product
    GM Helix Acqua Implant 3.5x10, Article No. 140.944
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2022·2021-11-10

    ADVIA Centaur SARS-CoV-2 Antigen Assay Recalled for Insufficient Validation Data

    Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.

    Product
    ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2022·2021-11-10

    Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data

    Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.

    Product
    Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2022·2021-11-10

    Dental implants recalled for size mismatch with package labeling

    Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.

    Product
    ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2022·2021-11-10

    FDA Recalls 3M Red Dot ECG Monitoring Electrodes Due to Potential Carbon Stud Breakage

    3M Red Dot ECG monitoring electrodes (Catalog No. 2244) are being recalled due to potential breakage of the carbon stud from the eyelet. Approximately 2,081,000 units distributed nationwide and internationally are affected.

    Product
    3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2022·2021-11-10

    Arietta 750 Ultrasound Software Versions Affected by Incorrect Measurement Display

    FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.

    Product
    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0201-2022·2021-11-10

    Medtronic Neuromodulation Clinician Programmer Application Software Anomaly Recall

    Medtronic recalled the Clinician Programmer Application (CPA) model A610 due to a potential software anomaly. Affected versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081 have been distributed worldwide. No illnesses or injuries have been reported.

    Product
    Clinician Programmer Application (CPA) model A610 Clinician Software Application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0185-2022·2021-11-10

    Flexor Check-Flo Introducer recalled for misplaced radiopaque marker

    Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.

    Product
    Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0202-2022·2021-11-10

    Aspiration Syringe Kit MVSK60 Inadvertently Shipped with OUS Labeling

    MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.

    Product
    Aspiration Syringe Kit, REF: MVSK60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0118-2022·2021-11-03

    Surgical Brain Guidance System Recalled for Inaccurate Electrode Placement

    ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.

    Product
    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2022·2021-11-03

    Medtronic recalls C315-HIS Delivery Catheters due to functional defect

    Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.

    Product
    C315-HIS Delivery Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0164-2022·2021-11-03

    Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date

    W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.

    Product
    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0179-2022·2021-11-03

    BD Syringe Tip Cap Packaging Defect May Compromise Sterility

    Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.

    Product
    BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
    Category
    Medical Device
    Distribution
    1 state