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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

4026–4050 of 39987

  • 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-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-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-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-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-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-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-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-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-1686-2025·2025-05-07

    IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings

    Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.

    Product
    IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. 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
  • LowFDA (Devices)·Z-1690-2025·2025-05-07

    Semi-Automated External Defibrillators Missing Italian Language Labeling

    Defibtech is recalling semi-automated external defibrillators (Models DDU-100 and DDU-100E) distributed in Switzerland because they lack required Italian language labeling and instructions for use.

    Product
    Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1694-2025·2025-05-07

    Defibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation

    Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland due to missing Italian translation of product labeling and instructions, which violates Swiss Medical Devices Ordinance requirements.

    Product
    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1691-2025·2025-05-07

    Automated External Defibrillators DDU-2200 Missing Italian Language Translation

    Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.

    Product
    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1585-2025·2025-04-30

    Novasight Hybrid Catheter Recalled for Potential Sheath Detachment

    Conavi Medical Inc. is recalling the Novasight Hybrid Catheter (Model TA-06-0001) due to manufacturing issues that could cause the catheter sheath to detach. The device is used for diagnostic intravascular imaging.

    Product
    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1643-2025·2025-04-30

    Amplatzer TorqVue LP Delivery System Recall for Shaft Breach

    Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer medical device recall

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because expired reagents may be used without user notification when scanned or manually entered into the system, contrary to manufacturer guidelines.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2025·2025-04-30

    Abbott CELL-DYN Ruby hematology analyzer affected by expired reagent date masking

    Abbott is recalling the CELL-DYN Ruby hematology analyzer because expired reagents may have their expiration dates automatically changed to current or future dates without user notification, potentially leading to use of expired reagents.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer system expiration date validation

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (model 08H67-13) because expired reagents can be used without proper notification when their expiration dates are scanned or entered into the system.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2025·2025-04-30

    Medtronic NIM Vital Nerve Monitoring System Software Version Recall

    Medtronic is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased stimulus artifact that may require troubleshooting and could lead to procedure delay, extubation, and medical intervention.

    Product
    NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1650-2025·2025-04-30

    InPen Smart Insulin Pen Recall Due to Incorrect Assembly

    Medtronic MiniMed is recalling InPen smart insulin pens that may have been incorrectly assembled, potentially causing the insulin cartridge to not fit or the cartridge holder to be difficult to remove. Users without backup insulin could experience temporary hyperglycemia.

    Product
    InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1583-2025·2025-04-30

    Zenition 70 Medical Device Recall: Unintended Radiation Exposure Risk

    Philips is recalling Zenition 70 systems with Vascular Extension option and Wireless Foot Switch due to potential for unintended radiation exposure in healthcare facilities.

    Product
    Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2025·2025-04-30

    CELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect

    Abbott's CELL-DYN Ruby hematology analyzer may accept expired reagents without alerting the operator, potentially allowing use of expired materials in patient testing.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2025·2025-04-30

    BD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect

    CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.

    Product
    BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2025·2025-04-30

    Rover Mobile X-ray System internal fastening mechanism failure potential

    Micro-X Ltd. is recalling Rover Mobile X-ray System units (models MXU-RV71, MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Affected units were distributed in New Jersey, Washington, and Puerto Rico.

    Product
    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring med
    Category
    Medical Device
    Distribution
    3 states