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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14576–14600 of 39988

  • HighFDA (Devices)·Z-1636-2021·2021-05-26

    Biopsybell Easynject Device Recalled for Potential Sterility Failure

    Biopsybell is recalling five Easynject vertebroplasty devices because they were labeled sterile but may not have been sterilized.

    Product
    EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2021·2021-05-26

    Boston Scientific Recalls VICI Venous Stent System Due to Migration Reports

    Boston Scientific is recalling VICI Venous Stent Systems because the company received reports of stent migration after implantation.

    Product
    VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2021·2021-05-26

    Biopsybell 10G Direct Working Cannula Recalled for Sterilization Concerns

    Biopsybell is recalling 10G Direct Working Cannulas labeled as sterile because they may not have been sterilized. The recall affects 50 units distributed in Mississippi and Kentucky.

    Product
    10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2021·2021-05-26

    WillowWood Alpha Interlock Suspension System Lanyard Body Recalled for Pin Defect

    WillowWood Global LLC is recalling 815 Alpha Interlock Suspension System Lanyard Bodies because a shorter dowel pin was used, which may cause the suspension cord to slip or come loose.

    Product
    Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1610-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate elevated glucose readings when used with hydroxyurea.

    Product
    Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1608-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate glucose readings when used with hydroxyurea.

    Product
    Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1614-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings

    Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1600-2021·2021-05-26

    Medtronic Enlite Glucose Sensor Recalled for Inaccurate Readings with Hydroxyurea

    Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea can cause inaccurate elevated readings.

    Product
    Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1609-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high glucose readings.

    Product
    Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1622-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Mold Contamination

    Bioseal Corporation is recalling Central Line Dressing Kits because the ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1663-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2021·2021-05-26

    Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure

    Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.

    Product
    10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2021·2021-05-26

    RayStation Software Recall Due to Dose Labeling Error in Merged Beams

    RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.

    Product
    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea

    Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1660-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects

    Bard Access Systems is recalling specific Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling specific Groshong NXT ClearVue catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1593-2021·2021-05-26

    Gore Viabil Biliary Endoprosthesis Recalled for Length Discrepancy

    W.L. Gore & Associates is recalling 61 Gore Viabil Biliary Endoprosthesis devices because a complaint reported a device appeared shorter than its labeled length.

    Product
    GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1621-2021·2021-05-26

    Boston Scientific Recalls ELUVIA Drug-Eluting Vascular Stent System Due to Packaging Error

    Boston Scientific is recalling 27 units of the ELUVIA Drug-Eluting Vascular Stent System because some 6x40mm stents were incorrectly placed in 6x100mm packaging.

    Product
    ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1553-2021·2021-05-19

    ReWalk Robotics Recalls Powered Exoskeletons Due to Fire Risk

    Argo Medical Technologies is recalling ReWalk Personal and R Systems exoskeletons after reports that the waistpack battery packs caught fire while charging.

    Product
    ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2021·2021-05-19

    Meridian Revogene RNA Software Upgrade Kits Recalled Due to False Negatives

    Meridian Bioscience is recalling 124 Revogene RNA Software Upgrade Kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1540-2021·2021-05-19

    Meridian Revogene SARS-CoV-2 Test Recalled Due to False Negative Results

    Meridian Bioscience is recalling 376 Revogene SARS-CoV-2 test kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2021·2021-05-19

    GE Healthcare Recalls NM/CT 870 DR Scanners for Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 870 DR scanners because a specific workflow may cause a shift in CT radiation exposure range, potentially requiring patient re-scans.

    Product
    NM/CT 870 DR Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2021·2021-05-19

    Atos Medical Recalls Provox Life Night HME Devices Due to Insertion Risk

    Atos Medical AB is recalling Provox Life Night HME devices because they may be incorrectly inserted, potentially blocking the patient's stoma.

    Product
    Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
    Category
    Medical Device
    Distribution
    Distributed nationwide