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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3976–4000 of 39824

  • SevereFDA (Devices)·Z-1624-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall

    GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2025·2025-05-07

    Belmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack

    Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit (Model 902-00037) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leaks during use.

    Product
    Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2025·2025-05-07

    Stratus CS Acute Care cTNI TestPak cardiac troponin test recall

    Siemens Healthcare Diagnostics is recalling Stratus CS Acute Care cTNI TestPak, a cardiac troponin I test, due to an increased occurrence of false positive results during the product's shelf life.

    Product
    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2025·2025-05-07

    Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles

    Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2025·2025-05-07

    epoc BGEM BUN Test Cards for Blood Analysis System Recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2025·2025-05-07

    Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test results.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2025·2025-05-07

    Belmont 3.0 Liter Disposable Set Recalled for Cracked Female Connector

    Belmont Instrument LLC is recalling the 3.0 Liter Disposable Set (Model 903-00032) due to a potential crack in the female connector on the Heat Exchanger/patient line set that can cause fluid leaks during device priming.

    Product
    3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Leaking at Seal Interface

    Medline is recalling sterile water and 0.9% normal saline bottles due to leaking at the peel-foil and bottle opening interface. The defect affects 159 units distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: HAND, REF DYNJ902002J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1712-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals

    Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2025·2025-05-07

    Automated External Defibrillator Model DDU-2450 Missing Italian Translation

    Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.

    Product
    Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1661-2025·2025-05-07

    Trimble RTS873 Robotic Total Station Green Laser Safety Issue

    Trimble is recalling 127 RTS873 robotic total stations because the green aiming laser output power may exceed its Class 2 laser safety classification. Units were produced between October 2023 and February 12, 2025 and distributed in the US, South Korea, and United Kingdom.

    Product
    The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1713-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking

    Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking Seals

    Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1715-2025·2025-05-07

    Olympus SOLTIVE Pro SuperPulsed Laser System procedural parameter issue

    Olympus is recalling the SOLTIVE Pro SuperPulsed Laser System because preset treatment parameters may not be consistently applied according to the instructions for use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and poten
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2025·2025-05-07

    Hyperthermia Pump Procedure Kit Recalled for Cracked Connector

    Belmont Instrument LLC is recalling 158 Hyperthermia Pump Procedure Kits (Model 902-00045) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leakage during use.

    Product
    Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2025·2025-05-07

    Belmont Hyperthermia Pump Line Kit Heat Exchanger Connector Crack Recall

    Belmont Instrument is recalling the Straight Inflow/Bifurcated Outflow Line Kit (Model 902-00038) due to potential cracks in the female connector on the Heat Exchanger set, which may cause fluid leaks during priming.

    Product
    Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2025·2025-05-07

    Defibtech Automated External Defibrillators Model DDU-2300 Recalled

    Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.

    Product
    Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1708-2025·2025-05-07

    Medline Non Sterile I&D Kit Procedure Kits Recalled for Leaking Bottles

    Medline Industries is recalling Non Sterile I&D Kit procedure kits (Lot 23KDB283) because Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide, including the US, Panama, and Canada.

    Product
    Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2025·2025-05-07

    IceSeed CX Cryoablation Needles Recalled for Demo Programming Issue

    Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 because they were programmed with demo settings instead of commercial settings. If disconnected and reconnected during use, the system will prompt unnecessary recalibration testing.

    Product
    IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2025·2025-05-07

    IceSeed 1.5 CX Cryoablation Needles Recalled for Incorrect Software Settings

    Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 due to incorrect software programming. Affected needles may prompt unnecessary Needle Integrity and Functionality Tests if disconnected and reconnected during use.

    Product
    IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2025·2025-05-07

    epoc BGEM Crea Test Card for Blood Analysis System recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card (25 pk) units due to discrepant high pH results in samples with higher injection volumes. The recall affects 5,207 units distributed nationwide and internationally.

    Product
    epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1683-2025·2025-05-07

    HistoCore PELORIS 3 Rapid Tissue Processor Manifold Tubing Leakage

    Leica Biosystems is recalling 77 units of the HistoCore PELORIS 3 Rapid Tissue Processor due to a leakage issue in the manifold tubing. The affected units were distributed across 14 US states.

    Product
    HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1707-2025·2025-05-07

    Medline procedure kits recalled for leaking sterile water and saline bottles

    Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.

    Product
    Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2025·2025-05-07

    Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed

    Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.

    Product
    IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2025·2025-05-07

    Medline Sterile 0.9% Normal Saline 100mL bottles recalled for leaks

    Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.

    Product
    Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
    Category
    Medical Device
    Distribution
    Distributed nationwide