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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3851–3875 of 39948

  • HighFDA (Devices)·Z-1823-2025·2025-06-04

    Cardiohelp System HKH 8820 Wall Holder Mounting Bracket Recall

    The Cardiohelp System HKH 8820 Wall Holder, a mounting bracket for the CARDIOHELP-i system used in interhospital transport, does not comply with standard DIN EN 1789:20 and may detach during use.

    Product
    Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1860-2025·2025-06-04

    DORO Easy-Connect Navigation Adaptor compatibility issue recall

    Pro-Med Instruments is recalling the DORO Easy-Connect Navigation Adaptor due to potential compatibility problems that could affect positioning accuracy and navigation system function. The company distributed 217 units worldwide.

    Product
    DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2025·2025-06-04

    BioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect

    BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.

    Product
    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1879-2025·2025-06-04

    Segmental Stem Components for ELEOS Limb Salvage System Recalled

    Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.

    Product
    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1825-2025·2025-06-04

    Abbott Rapid DX Cholestec LDX Lipid Profile Test Cassettes Recall

    Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2025·2025-06-04

    Glidewell HT Implant Twist Drill recalled due to packaging mix-up

    Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm devices due to a packaging mix-up that resulted in incorrect finished devices being placed in packages.

    Product
    Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2025·2025-06-04

    VITROS Chemistry Products CRP Slides Incorrectly Labeled Coating Generation

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because the product carton, foil wrapper, and cartridge label were incorrectly marked with "GEN 88" instead of the correct "GEN 83" designation.

    Product
    VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2025·2025-06-04

    Abbott Diagnostics Architect Progesterone Reagent Storage Condition Recall

    Abbott Diagnostics Architect Progesterone (100 tests) reagent is being recalled due to transit delays during severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1859-2025·2025-06-04

    Ultrasonic Cleaning Systems Triton 36 and 72 recalled

    Ultra Clean Systems, Inc. is recalling Ultrasonic Cleaning Systems Triton 36 and Triton 72 models due to carbon filter sensors breaking down from electrochemical degradation. The defect was identified during routine preventative maintenance checks.

    Product
    Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1842-2025·2025-06-04

    Abbott Diagnostics ARCH AUSAB Anti-HBS Reagent Recall

    Abbott Diagnostics ARCH AUSAB Anti-HBS reagent units may have been stored outside recommended temperature conditions due to transit delays caused by severe thunderstorms, potentially leading to incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2025·2025-06-04

    Ethos Collar Stem components recalled for potential Tyvek seal breach

    Onkos Surgical is recalling Ethos Collar Stem components used in limb salvage systems due to potential breach of Tyvek seals. The recall affects 233 units distributed across multiple U.S. states.

    Product
    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1861-2025·2025-06-04

    Straumann Plus Initial Drill missing laser engraving marking

    Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the required 7 mm laser engraving marking.

    Product
    Plus Initial Drill, Article Number: 103.170;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1836-2025·2025-06-04

    Ortho Clinical Diagnostics Anti-B Bioclone diagnostic reagent recalled

    Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2025·2025-06-04

    BD Microbiology Fluid Thioglycollate Medium Tubes Recall

    McKessan Medical-Surgical is recalling BD Microbiology Fluid Thioglycollate Medium tubes due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, potentially resulting in incorrect or delayed test results.

    Product
    BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2025·2025-06-04

    HemoCue Inc Hemotrol Low Control affected by cold chain transit delays

    HemoCue Inc Hemotrol Low Level 1 control product was subject to transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially leading to incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1858-2025·2025-06-04

    Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly

    C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.

    Product
    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Cataly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1854-2025·2025-06-04

    Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set Recall

    Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set units may have been exposed to improper storage conditions during transit due to severe thunderstorms, which could result in incorrect or delayed test results.

    Product
    SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1847-2025·2025-06-04

    Abbott ARCHITECT HBSAG Assay Reagent Recall Due to Storage Condition Failure

    Abbott ARCHITECT HBSAG Assay reagent may have been stored outside recommended conditions due to transit delays caused by severe thunderstorms, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1843-2025·2025-06-04

    Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays

    Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1834-2025·2025-06-04

    Ortho Clinical Diagnostics Diluent Pack Recall Due to Cold Chain Failure

    McKesso Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics FS Diluent Packs due to transit delays from severe thunderstorms that may have caused improper storage conditions. The affected products could produce incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1855-2025·2025-06-04

    HemoCue Glucose Control Kit Affected by Improper Storage During Transit

    HemoCue Glucose Aqueous Control Kit units may have been stored outside recommended conditions due to transit delays during severe thunderstorms, potentially affecting test result accuracy.

    Product
    HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2025·2025-06-04

    Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue

    Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator units experienced transit delays due to severe thunderstorms, potentially exposing products to storage conditions outside the manufacturer's recommendations. This may increase the risk of incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2025·2025-06-04

    Abbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion

    Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2025·2025-06-04

    Segmental Stem Bowed 152MM components recall potential seal breach

    Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.

    Product
    Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1862-2025·2025-06-04

    GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm

    Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.984
    Category
    Medical Device
    Distribution
    Distributed nationwide