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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4901–4925 of 39968

  • 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-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-0942-2025·2025-01-22

    Sklar Instruments ECONO STERILE Blackhead Extractor Kits Recall

    Sklar Instruments is recalling ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. The kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-0919-2025·2025-01-22

    OsteoCove and Cove Putty bone void fillers recalled due to hydration defect

    IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty bone graft materials due to a hydration issue that makes the product less cohesive and moldable than intended.

    Product
    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
    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-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
  • 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-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
  • 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-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-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-0814-2025·2025-01-15

    Anesthesia Vaporizers May Deliver Less Anesthetic Than Dial Setting Due to Manufacturing Defect

    Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.

    Product
    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2025·2025-01-15

    Smaxel Fractional CO2 Laser recalled for missing safety label and instructions

    IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.

    Product
    Smaxel Fractional CO2 Laser, a Class IV medical laser system.
    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
    2 states
  • HighFDA (Devices)·Z-0819-2025·2025-01-15

    AMT Mini Enteral Extension Set Recalled for Incorrect Connector Type

    Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.

    Product
    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0803-2025·2025-01-15

    Beckman Coulter PTH Assay Reagent Packs Recalled for Filling Defects

    Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.

    Product
    Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2025·2025-01-15

    GE Optima XR Mobile Radiographic System Column Safety Mechanism Defect

    GE Healthcare Optima XR mobile X-ray systems with column replacements may have missing bolts in the Column Safety mechanism. If bolts are missing and the internal cable fails, the arm could drop, creating a risk of injury to staff or patients.

    Product
    GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0818-2025·2025-01-15

    Tec 850 SEV Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    GE Medical Systems recalls Tec 850 SEV anesthesia vaporizers due to a manufacturing defect that may cause them to deliver less anesthetic agent than the dial setting indicates. Affected devices distributed nationwide and globally.

    Product
    Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
    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-0802-2025·2025-01-15

    VACUETTE SAFELINK Blood Collection Holder May Leak Due to Defective Sleeve

    Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.

    Product
    VACUETTE SAFELINK, REF: 450210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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