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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2801–2825 of 13446

  • HighFDA (Devices)·Z-2112-2025·2025-07-23

    Laser Light Show Projectors Recalled for Missing Safety Interlocks and Labels

    Beyond Laser Systems is recalling laser light show projectors for missing safety interlocks and required labels. Affected models lack the remote interlock connector needed to prevent user exposure to Class IV laser radiation.

    Product
    Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2025·2025-07-23

    SwabCap Disinfecting Cap Needlefree Connector Seal Defect Recall

    ICU Medical is recalling SwabCap Disinfecting Caps due to a manufacturing defect that may prevent proper disinfection of needlefree connectors. The incomplete seal may cause isopropyl alcohol to evaporate, reducing effectiveness.

    Product
    SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2025·2025-07-23

    VITROS Chemistry CHE Slides Recalled for Quality Control Drift Risk

    Ortho-Clinical Diagnostics recalls VITROS Chemistry CHE Slides due to quality control drift occurring 2-7 days after reagent reconstitution, despite labels claiming 7-day stability. This may result in inaccurate and erroneous patient test results.

    Product
    VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2025·2025-07-23

    Microbiologics quality control kits recalled for organism content mismatch

    Microbiologics Inc is recalling KWIK-STIK and LYFO DISK quality control kits because they contain the wrong organism, which could cause laboratory quality control to fail and delay patient diagnosis.

    Product
    KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2122-2025·2025-07-23

    Medical Diagnostic Slides Recalled for Quality Control Drift

    Ortho-Clinical Diagnostics recalls VITROS Chemistry CHE Slides due to quality control drift in certain lots that may produce inaccurate test results when used within the labeled stability period.

    Product
    VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2025·2025-07-23

    Laser Light Show Projectors Recalled for Non-Functional Safety Interlock

    Beyond Laser Systems is recalling laser light show projectors with missing or non-functional remote safety interlocks that prevent safe shutdown of Class IV lasers. Projectors also lack required labeling and user documentation.

    Product
    Laser light show projectors manufactured by BLS, Model PURE 5000/10000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2025·2025-07-23

    VITROS Chemistry Products Performance Verifier Recalled for Quality Control Drift Risk

    Ortho-Clinical Diagnostics recalled certain lots of VITROS Chemistry Performance Verifier because quality control drift can cause inaccurate lab test results when used 2-7 days after reconstitution.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor perfo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2114-2025·2025-07-23

    NeuroSync EYE-SYNC Eye-Tracking Headsets Recalled Due to Inoperability

    NeuroSync recalled 27 EYE-SYNC eye-tracking headset units in New York, Texas, and Georgia because the devices became inoperable after support for the embedded Pico 2 platform ended August 31, 2023, and cannot be repaired.

    Product
    NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2080-2025·2025-07-16

    Arterial Cannula Recalled Due to Exposed Wire Protruding from Cannula

    Edwards Lifesciences is recalling Optisite Arterial Cannula units due to wire sections 3-4mm in length protruding from the cannula body, posing a patient injury risk.

    Product
    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorpo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2047-2025·2025-07-16

    Bravo CF capsule delivery device recalled for misapplied adhesive defect

    Given Imaging's Bravo CF capsule delivery device is recalled due to misapplied adhesive that may prevent the pH monitoring capsule from attaching to the esophagus or detaching from the delivery device. The recall affects 128,202 units distributed nationwide and globally.

    Product
    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2031-2025·2025-07-16

    Mobile patient lift component may improperly latch, risking patient falls

    The Hillrom Q-Link 13 quick-release hook component used in mobile patient lifts may improperly latch, potentially causing it to detach and result in patient falls.

    Product
    Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift -
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2084-2025·2025-07-16

    Edwards FEM-FLEX II Femoral Arterial Cannula Recalled for Exposed Wire

    Edwards Lifesciences recalls the FEM-FLEX II Femoral Arterial Cannula due to exposed wire protruding from the device body that could cause vascular injury.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2085-2025·2025-07-16

    Edwards FEMFLEXII Femoral Arterial Cannula Recalled for Exposed Protruding Wire

    Edwards Lifesciences is recalling the FEMFLEXII Femoral Arterial Cannula due to complaints of a 3mm to 4mm section of wire protruding from the cannula body, posing a risk of injury.

    Product
    Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2032-2025·2025-07-16

    Hillrom LikoScale patient lift adapter kits recalled for improper hook attachment

    Hillrom LikoScale adapter kits for patient lifts have false-latching defects in the Quick-Release Hook that can cause improper attachment and unexpected detachment, risking patient falls.

    Product
    Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2081-2025·2025-07-16

    Edwards OptiSite Arterial Cannula Recalled for Exposed Wire Defect

    Edwards Lifesciences is recalling OptiSite Arterial Cannulas (Model OPTI18) due to exposed wire protruding from the device body. Approximately 13,240 units distributed worldwide are affected.

    Product
    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorpo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2082-2025·2025-07-16

    FEM-FLEX II Femoral Arterial Cannula recalled for exposed wire defect

    Edwards Lifesciences is recalling FEM-FLEX II Femoral Arterial Cannula devices due to exposed or protruding wire sections on the cannula body. Approximately 6,801 units were distributed worldwide.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2083-2025·2025-07-16

    Edwards FEM-FLEX II Femoral Cannula Recalled for Exposed Wire Defect

    Edwards Lifesciences is recalling the FEM-FLEX II Femoral Arterial Cannula due to exposed wire segments protruding from the device body. The defect poses a mechanical hazard during arterial perfusion procedures.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2025·2025-07-16

    O-arm O2 Imaging System: Damaged Mechanical Support Component Recall

    Medtronic is recalling 3 units of the O-arm O2 Imaging System (mobile X-ray equipment) in IN, MN, and MS due to potential damage to a mechanical component supporting the gantry during manufacturing.

    Product
    O-arm O2 Imaging System. Mobile X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2025·2025-07-16

    Infinia Nuclear Medicine Systems Detector Motion Risk from Software Defect

    Certain Infinia nuclear medicine systems may experience unintended detector motion during patient setup or scanning if the gantry software is not up to date, potentially causing serious injury.

    Product
    Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2025·2025-07-16

    Preat Astra EV-compatible 4.2mm Digital Analog Device Recalled for Rotational Defect

    Preat Corp is recalling Astra EV-compatible 4.2mm Digital Analog devices due to a manufacturing error that misaligns the rotational feature by 180 degrees. Affected units were distributed nationwide to nine states.

    Product
    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2025·2025-07-16

    GE Nuclear Medicine Imaging Systems Recalled for Unintended Detector Motion

    GE's Varicam, Millennium VG, and Discovery VH nuclear medicine imaging systems may experience unintended detector motion during patient setup or scanning if the gantry software is not the correct version, potentially causing life-threatening injury.

    Product
    Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2025·2025-07-16

    Boston Scientific VersaCross Guide Wire Sterile Barrier Defect

    Boston Scientific is recalling VersaCross Access Solution guide wires due to potential holes in the sterile barrier pouch that may compromise device sterility and could lead to systemic infection.

    Product
    VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2025·2025-07-16

    Alcon Constellation Vitrectomy Procedure Pak Recalled for Potential Manufacturing Defect

    Alcon Laboratories is recalling specific lots of Constellation Vision System Vitrectomy Procedure Paks due to potential manufacturing damage to the lidding that could compromise sterility.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2025·2025-07-16

    Alcon Constellation Vision System Procedure Packs Recalled for Sterility Risk

    Alcon Laboratories is recalling certain Constellation Vision System Combined Procedure Paks (89,495 units) due to potential damage to the lidding that may compromise sterility. Affected products were distributed worldwide.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2025·2025-07-16

    Torflex Transseptal Guiding Sheath Kit recalled for sterile barrier defects

    Boston Scientific is recalling Torflex Transseptal Guiding Sheath Kits due to potential holes in the sterile barrier pouch that may compromise device sterility. The defect could lead to systemic infection and sepsis.

    Product
    Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atri
    Category
    Medical Device
    Distribution
    Distributed nationwide