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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4151–4175 of 13543

  • HighFDA (Devices)·Z-0929-2025·2025-01-22

    Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2025·2025-01-22

    Surgical Forceps Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 373 Resano Forceps due to increased complaints of frayed or broken grip cables on the reusable surgical instruments. Affected healthcare providers should contact the manufacturer for guidance.

    Product
    8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0907-2025·2025-01-22

    Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results

    Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.

    Product
    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0853-2025·2025-01-22

    Surgical Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.

    Product
    8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0845-2025·2025-01-22

    X-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect

    Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.

    Product
    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2025·2025-01-22

    Surgical Retractor Grip Cables May Fray or Break During Use

    Intuitive Surgical is recalling 738 units of the 8MM Atrial Retractor (Model 470246) due to reports of frayed or broken grip cables on reusable instruments. The defect could compromise instrument performance during surgical procedures.

    Product
    8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0955-2025·2025-01-22

    Demineralized Bone Matrix Putty Recalled for Incorrect Outer Box Expiration Date

    IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.

    Product
    OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0833-2025·2025-01-22

    Cook Medical Hiatal Hernia Graft Recalled for Documentation and Labeling Errors

    Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.

    Product
    Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0832-2025·2025-01-22

    Biodesign Otologic Butterfly Graft Recall: Incorrect Instructions and Expiration Date

    Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.

    Product
    Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0921-2025·2025-01-22

    DRG:HYBRiD-XL Insulin Device Recalled for Calibration Failures

    DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.

    Product
    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0711-2025·2025-01-15

    VasoView HemoPro 2 Endoscopic Vessel Harvesting System Class I Recall

    FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.

    Product
    VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0763-2025·2025-01-15

    Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure

    Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0795-2025·2025-01-15

    Oxygen Concentrator May Catch Fire or Melt During Use

    The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.

    Product
    JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0712-2025·2025-01-15

    Vasoview Hemopro 2 Vessel Harvesting System Recalled for Heater Wire and Silicone Defects

    Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.

    Product
    Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2025·2025-01-15

    3B Medical Oxygen Cannula Recall: Units Shipped After Expiration Date

    3B Medical recalled 5,010 Ultrasoft Oxygen Cannula units (Model O2U2012, Lot 20170403) distributed in Massachusetts and Arkansas because they were shipped after their expiration date.

    Product
    Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0820-2025·2025-01-15

    Citric acid dialysis concentrate recalled for incorrect case labeling

    Nipro Renal Solutions USA is recalling Citric Complete dry citric acid concentrate due to mislabeled outer cases that show incorrect potassium and calcium content values.

    Product
    Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0817-2025·2025-01-15

    GE Tec Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.

    Product
    Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2025·2025-01-15

    Tec 820 ISO Anesthesia Vaporizers can deliver less anesthetic than dial setting

    GE Medical Systems is recalling 644 Tec 820 ISO Anesthesia Vaporizers due to a manufacturing issue that causes them to deliver less anesthetic than the dial setting indicates. Distributed nationwide and globally.

    Product
    Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2025·2025-01-15

    Xhibit Telemetry Receiver software versions may cause unsolicited system shutdowns

    Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.

    Product
    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0807-2025·2025-01-15

    Neptune Medical Suction Rovers Recalled Due to Loose Bolts

    Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.

    Product
    100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0813-2025·2025-01-15

    Medical radiographic system arm drop hazard due to missing safety bolts

    GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

    Product
    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0808-2025·2025-01-15

    Aerin Medical VivAer Stylus Recall: Programming Error Causes Device Misidentification

    Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.

    Product
    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide