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.

Filters

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

5551–5575 of 39844

  • HighFDA (Devices)·Z-0224-2025·2024-10-30

    Quantum Perfusion Systems CPB Roller Pumps Recalled for Mechanical Locking Defect

    Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems CPB Roller Pumps due to an out-of-tolerance ratchet and pawl defect preventing proper bobbin locking. This defect may affect blood circulation control during cardiac surgery.

    Product
    Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0084-2025·2024-10-30

    Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled

    Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.

    Product
    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2025·2024-10-30

    Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk

    Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.

    Product
    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2025·2024-10-30

    Internal Defibrillation Paddles Recalled for Cracks and Separation

    Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.

    Product
    STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2025·2024-10-30

    Smiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects

    Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.

    Product
    medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0197-2025·2024-10-30

    Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits

    Smiths Medical ASD, Inc. is recalling 800 units of medex TranStar KIDS KIT closed blood sample kits due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0158-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Sterility Compromise

    Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2025·2024-10-30

    Boston Scientific myLUX Patient Application Recalled for Data Transmission Failure

    Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.

    Product
    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2025·2024-10-30

    Medline Procedure Kits Recalled for Non-Sterile Product Risk

    Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2025·2024-10-30

    Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation

    Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.

    Product
    Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0207-2025·2024-10-30

    Diasol Acid Concentrate Recalled for Labeling Discrepancy

    Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.

    Product
    Diasol Acid Concentrate REF G100325-10Dex 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2025·2024-10-30

    Smiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns

    Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.

    Product
    smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0209-2025·2024-10-30

    Blue Ortho Recalls Predict+ Software for Lack of FDA Clearance

    Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.

    Product
    Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0138-2025·2024-10-30

    Quantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure

    Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.

    Product
    Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2025·2024-10-30

    Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming

    Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.

    Product
    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Class II Recall

    Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0047-2025·2024-10-23

    GE HealthCare Giraffe OmniBed neonatal incubator door screw may loosen

    Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.

    Product
    GE Heathcare Giraffe OmniBed; neo natal incubator
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0048-2025·2024-10-23

    GE HealthCare Recalls Giraffe OmniBed Carestations Due to Door Screw Issue

    GE HealthCare is recalling certain Giraffe OmniBed Carestations because a screw securing the heater doors may not be torqued to specification, potentially causing the doors to become loose.

    Product
    GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0131-2025·2024-10-23

    Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk

    Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2025·2024-10-23

    Monarch Inflation Devices Recalled for Sterile Barrier Defects

    Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.

    Product
    Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2025·2024-10-23

    Medline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling

    Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.

    Product
    MEDLINE HEART CABG CDS, REF CDS983376R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2025·2024-10-23

    Merit Medical basixSKY Inflation Device Recalled for Sterile Barrier Defect

    Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.

    Product
    basixSKY Inflation Device, REF: SKY1802
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2025·2024-10-23

    Leica Cryostat Model CM1850 Lacks Fire-Risk Warning for Flammable Sprays

    Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.

    Product
    Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2025·2024-10-23

    Blue Diamond Digital Inflation Devices Recalled for Sterile Barrier Defect

    Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.

    Product
    Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2025·2024-10-23

    Custom Inflation Kits Recalled Due to Sterile Barrier Defect and Infection Risk

    Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.

    Product
    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K0
    Category
    Medical Device
    Distribution
    Distributed nationwide