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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3876–3900 of 39948

  • ModerateFDA (Devices)·Z-1846-2025·2025-06-04

    Abbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure

    McKesson Medical-Surgical is recalling Abbott Point of Care Test Creatinine I-STAT cartridges distributed nationwide after transit delays during severe thunderstorms caused improper storage conditions, increasing the risk of incorrect or delayed test results.

    Product
    ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1832-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS Phosphorus Reagent Recall

    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS reagent units may have been stored outside recommended cold chain conditions due to severe thunderstorms, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2025·2025-06-04

    Male-Female Midsection components from ELEOS Segmental Limb Salvage System

    Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.

    Product
    Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Mal
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1830-2025·2025-06-04

    Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure

    Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2025·2025-06-04

    Abbott Diagnostics Probe Conditioning Solution Recall

    Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1837-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide

    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN clinical reagent is being recalled due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2025·2025-06-04

    BD Microbiology MacConkey II Agar Media Storage Condition Recall

    BD Microbiology MacConkey II Agar media may have been stored outside recommended temperature conditions due to transit delays from severe thunderstorms, potentially resulting in incorrect or delayed test results.

    Product
    BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2025·2025-06-04

    Abbott Diagnostics Alinity I Free PSA Reagent Affected by Storage Conditions

    Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.

    Product
    ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2025·2025-06-04

    Segmental Stem Components Recalled for Potential Tyvek Seal Breach

    Onkos Surgical is recalling Segmental Stem components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise sterility.

    Product
    Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1845-2025·2025-06-04

    Abbott Diagnostics HIV Combo Calibrator Affected by Cold Chain Exposure

    Abbott Diagnostics ARCHITECT HIV COMBO Calibrator units may have been exposed to improper storage temperatures due to transit delays during severe thunderstorms, potentially affecting test accuracy.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1853-2025·2025-06-04

    Abbott Diagnostics Alinity I Anti-CCPS Reagent Recall

    Abbott Diagnostics Alinity I Anti-CCPS Reagent is being recalled due to transit delays from severe thunderstorms that may have exposed the product to storage conditions outside the manufacturer's recommendations, potentially causing incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2025·2025-06-04

    HemoCue HemoTrol High Control Product Recalled Due to Storage Conditions

    HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2025·2025-06-04

    HemoCue Glucose 201 Analyzer Microcuvettes Recalled for Storage Conditions

    HemoCue INC F/Glucose 201 Analyzer microcuvettes are being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside recommended conditions, which could cause incorrect or delayed test results.

    Product
    HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1822-2025·2025-06-04

    Siemens ADVIA Centaur HCY Calibrator packs recalled for calibrator instability

    Siemens Healthcare Diagnostics is recalling certain lots of ADVIA Centaur HCY Calibrator (2 Pack) due to calibrator instability that causes increased positive bias and fails to meet reference interval specifications in the Instructions for Use.

    Product
    ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2025·2025-06-04

    Ortho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall

    Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Total Bili-Alkp XT (L-Sequester) reagent due to cold chain storage failures during transit caused by severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1821-2025·2025-06-04

    Atellica IM Homocysteine Calibrator recalled for assay instability

    Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.

    Product
    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1831-2025·2025-06-04

    Ortho Clinical Diagnostics Vitros Calcium Reagent Recalled Due to Storage Conditions

    Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent is being recalled because transit delays caused by severe thunderstorms may have stored products outside recommended cold chain conditions, potentially leading to incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1815-2025·2025-06-04

    Apo B Reagent calibration error may produce inaccurate test results

    Beckman Coulter is recalling Apo B Reagent due to an erroneous value in the calibration sheet that could generate incorrect patient test results with positive bias up to 42%.

    Product
    Apo B Reagent, REF: OSR6143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1746-2025·2025-05-28

    Endopath Echelon Vascular White Reload surgical stapler device lockout

    Ethicon Endo-Surgery is recalling the Endopath Echelon Vascular White Reload surgical stapler due to reports of inadvertent instrument lockout during procedures. The lockout prevents cutting and stapling, potentially requiring conversion to open surgery; one patient death has been reported.

    Product
    Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1767-2025·2025-05-28

    Baxter Novum IQ LVP Infusion System underinfusion risk recall

    Baxter Healthcare is recalling the Novum IQ LVP Infusion System because the device may deliver less medication than intended when using standby mode or after being powered off with the set loaded.

    Product
    Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1760-2025·2025-05-28

    Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk

    Centerline Biomedical is recalling the IOPS Guidewire 2 (Lot 2404-2005) because the coating may delaminate during use, potentially compromising the guidewire's function during catheter placement procedures.

    Product
    Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1759-2025·2025-05-28

    Bard Single Intragastric Linton Balloon Tube difficult plastic plug removal

    C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) because users may be unable or find it difficult to remove plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1758-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Intermediate Balloon Inflation Difficulty

    C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Intermediate, REF 0092300) due to reports that plastic plugs may be difficult or impossible to remove, preventing proper inflation of the gastric and/or esophageal balloons.

    Product
    Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1755-2025·2025-05-28

    Bard Minnesota Four Lumen Esophagogastric Tamponade Tube Recalled

    C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1757-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Child Difficult Plug Removal

    C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Child) due to customer complaints that plastic plugs may be difficult or impossible to remove, preventing inflation of the gastric and esophageal balloons.

    Product
    Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
    Category
    Medical Device
    Distribution
    52 states