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

Agency

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

10401–10425 of 27647

  • HighFDA (Devices)·Z-0097-2025·2024-10-23

    AVVIGO+ Multi-Modality Guidance System software defect causes incorrect grid display

    Boston Scientific recalled the AVVIGO+ Multi-Modality Guidance System because a software defect causes incorrect grid display in Live and Record modes, potentially affecting vessel imaging guidance for physicians using OptiCross 18 catheters.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2025·2024-10-23

    Leica Cryostat Model CM1900 Lacks Warning on Flammable Sprays

    Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.

    Product
    Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2025·2024-10-23

    Medline Open Heart Surgical Kit Recall for Model Labeling Error

    Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.

    Product
    MEDLINE OPEN HEART, REF DYNJ904261B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2025·2024-10-23

    Leica Biosystems Cryostat Model CM3050 S lacks warning label for flammable sprays

    Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.

    Product
    Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2025·2024-10-23

    Beckman Coulter Recalls Immunochemistry IGM Reagent Lots for Sensitivity Failure

    Beckman Coulter is recalling two lots of IGM reagent used in IMMAGE immunochemistry systems because they don't meet sensitivity specifications. The reagent measures immunoglobulin M levels in blood samples.

    Product
    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
    Category
    Medical Device
    Distribution
    15 states
  • SevereCPSC·25011·2024-10-17

    Anker Power Banks Recalled for Fire and Burn Hazards

    Anker power banks with model numbers A1642, A1647, and A1652 have been recalled because the lithium-ion battery can overheat and catch fire, causing burn injuries. The firm has received 28 reports of overheating and fires, with two burn injuries reported.

    Product
    Anker Power Banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25015·2024-10-17

    Colsen Fire Pits Recalled for Burn Injury Risk from Flame Jetting

    Colsen-branded tabletop fire pits are being recalled due to the risk of invisible alcohol flames causing flame jetting and fire spreading. The hazard can cause serious burns in less than one second.

    Product
    Colsen-branded fire pits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25012·2024-10-17

    Oliva Cigars Recalls Slim Lighters Missing Child-Safety Feature

    About 60,000 promotional cigar slim lighters branded Nub, Serie V, Cain, and Oliva lack child-resistant mechanisms and pose fire and burn hazards to young children under age 5.

    Product
    Nub, Serie V, Cain, and Oliva branded Promotional Cigar Slim Lighters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25701·2024-10-17

    Arctic Cat and Tracker Off-Road Vehicles Recalled for Crash Hazard

    Textron Specialized Vehicles is recalling about 7,000 model year 2022–2024 Arctic Cat Prowler Pro and Tracker Off Road 800SX side-by-side vehicles because they can move while the digital dash displays "park," creating a rollaway crash hazard.

    Product
    Model Years 2022-2024 Arctic Cat Prowler Pro / Pro Crew and Tracker Off Road 800SX / 800SX Crew Side by Side Recreational Off Highway Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0005-2025·2024-10-16

    Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect

    Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.

    Product
    Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0008-2025·2024-10-16

    Vail-Bon Jie Yang Wan capsules recalled for undeclared pharmaceutical ingredients

    Vail-Bon Jie Yang Wan capsules have been recalled for containing undeclared dexamethasone and chlorpheniramine. The product was marketed without FDA approval.

    Product
    Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0023-2025·2024-10-16

    7-Eleven Fudge Brownies Recalled Due to Undeclared Walnuts

    Innovation Bakers has recalled 7-Eleven Fudge Brownies with Chocolate Chip due to undeclared walnuts. The product was distributed to Southern California 7-Eleven stores and may cause allergic reactions in consumers with walnut allergies.

    Product
    7-Eleven Fudge Brownie with Chocolate Chip, 3.5 oz. UPC: 05254856392
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0050-2025·2024-10-16

    StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects

    Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.

    Product
    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2025·2024-10-16

    Check-Flo Performer Introducer Set white caps may disconnect

    Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to white caps that may disconnect from the shaft-hub connection. Affected units were distributed to Australia.

    Product
    Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0053-2025·2024-10-16

    Medline Sterile Laparoscopy Pack Recalled for Component Defect

    Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.

    Product
    Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2025·2024-10-16

    Knee Replacement Implant Recalled for Out-of-Spec Locking Tabs

    The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.

    Product
    Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2025·2024-10-16

    Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels

    Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.

    Product
    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0025-2025·2024-10-16

    Coca-Cola recalls Minute Maid Zero Sugar Lemonade due to mislabeling

    COCA COLA Consolidated LLC recalls Minute Maid Zero Sugar Lemonade cartons sold in Indiana, Kentucky, and Ohio. Regular Minute Maid Lemonade cans were incorrectly placed in Zero Sugar packaging.

    Product
    Minute Maid Zero Sugar Lemonade 12 cans carton UPC 0 25000 12115 9 CANNED UNDER THE AUTHORITY OF THE COCA-COLA COMPANY, ATLANTA, GA
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0038-2025·2024-10-16

    3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination

    3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.

    Product
    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0042-2025·2024-10-16

    Respiratory Pathogen Panel Recalled Due to False Positive Results

    The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.

    Product
    NxTAG Respiratory Pathogen Panel, REF: I051C0447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2025·2024-10-16

    FDA Recalls EPIONE Device Due to Internal Component Corrosion

    Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.

    Product
    The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. Du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2025·2024-10-16

    Medical Analyzer Software Flaw Allows Use of Expired Calibrator

    Beckman Coulter DxI 9000 immunoassay analyzers with software version 1.16.2 and prior can process orders using expired calibration material, potentially producing incorrect patient laboratory test results.

    Product
    Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0026-2025·2024-10-16

    BD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results

    BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.

    Product
    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2025·2024-10-16

    Endoscopy and Bronchoscopy Systems Power Cord Defect Risk

    Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.

    Product
    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
    Category
    Medical Device
    Distribution
    Distributed nationwide