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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3826–3850 of 39948

  • ModerateFDA (Devices)·Z-1905-2025·2025-06-11

    MIRA Surgical System software update recall for motion display issue

    Virtual Incision Corporation is recalling MIRA Surgical System units with Software Version 4.0.3 due to potential interrupted motion on the surgeon control console display caused by software latency.

    Product
    MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1878-2025·2025-06-11

    Lazervida 10W Diode Laser Engraver Does Not Meet Federal Safety Standards

    Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver because it does not fully meet current Federal performance standards for laser device safety features and labeling.

    Product
    Lazervida 10W diode laser cutter and engraver with Lazervida shield.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1890-2025·2025-06-11

    FoundationOne Companion Diagnostic contains incorrect negative claims

    Foundation Medicine is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports that contained an incorrect negative claim on the claims page, though the device variant information displayed correctly in the tumor profiling section.

    Product
    FoundationOne Companion Diagnostic (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2025·2025-06-11

    DxI 9000 Access Immunoassay Analyzer Software Update Error Codes

    Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers running software version 1.20 because the update introduces error codes that prevent assays from being performed and may delay result generation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2025·2025-06-11

    Pre-filled Water Syringe recalled for improper use contamination

    Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.

    Product
    Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2025·2025-06-11

    Beckman Coulter Sample Probe Manufacturing Defect Recall

    Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.

    Product
    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2025·2025-06-04

    ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall

    Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1818-2025·2025-06-04

    ELEOS Collar Stem 15mm mistakenly labeled as 13mm modular stem

    Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2025·2025-06-04

    Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion

    Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect

    Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2025·2025-06-04

    Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires

    Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 units distributed worldwide.

    Product
    Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2025·2025-06-04

    Abbott Diagnostics Architect Free T4 Calibrator Recall

    Abbott Diagnostics Architect Free T4 Calibrator units may have been exposed to improper storage conditions due to transit delays from severe thunderstorms, potentially causing incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter recalled for sterility defect

    Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.

    Product
    Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2025·2025-06-04

    ELEOS Male-Female Midsection 40MM Orthopedic Component Recall

    Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.

    Product
    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Triple Lumen Recall

    Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall

    Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.

    Product
    Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2025·2025-06-04

    Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach

    Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.

    Product
    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1826-2025·2025-06-04

    Cholestech LDX Lipid Profile and Glucose Test Kits Recalled

    McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2025·2025-06-04

    Ortho Clinical Diagnostics Vancomycin Reagent Cold Chain Recall

    Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Vancomycin reagent (Catalog No. 6801709) distributed nationwide due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.

    Product
    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2025·2025-06-04

    Abbott Diagnostics ARC T-Uptake Assay Reagent Recalled for Storage Excursion

    Abbott Diagnostics ARC T-Uptake Assay reagent is being recalled because severe thunderstorms caused certain units to be stored outside recommended temperature conditions, which may result in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2025·2025-06-04

    GM Helix Acqua Implant dental implant size misidentification recall

    Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2025·2025-06-04

    Abbott Diagnostics Vitamin D Calibrator Transit Storage Conditions Issue

    The Abbott Diagnostics Architect Vitamin D 6-Level Calibrator was exposed to improper storage conditions during transit due to severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2025·2025-06-04

    NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk

    NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.

    Product
    NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
    Category
    Medical Device
    Distribution
    Distributed nationwide