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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3701–3725 of 39948

  • HighFDA (Devices)·Z-2018-2025·2025-07-02

    CDI OneView System BPM Probe temperature sensor measurement inaccuracy

    Terumo Cardiovascular Systems is recalling CDI OneView System BPM Probe units due to thermistor assembly errors that cause inaccurate temperature and blood gas measurements, potentially leading to inappropriate clinical decisions.

    Product
    CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction defect

    Becton Dickinson is recalling one lot of BD Insyte Autoguard Shielded IV Catheters (REF 381433, 20GA x 1.00 in) due to reports that the catheter needle may retract slowly or fail to retract completely.

    Product
    REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2025·2025-07-02

    BD Insyte Autoguard BC Pro IV Catheter Needle Retraction Defect

    Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (REF 382944) due to reports that the catheter needle may retract slowly or fail to retract completely.

    Product
    REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2025·2025-07-02

    GE Healthcare LOGIQ F R3 Ultrasound System Incorrect Fetal Weight Data Display

    GE Healthcare is recalling the LOGIQ F R3 ultrasound system because it may display previous obstetric patient data in fetal weight measurements, potentially leading to incorrect clinical decisions about fetal size and growth.

    Product
    GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2034-2025·2025-07-02

    Philips Spectral CT Computed Tomography X-ray System Software

    Philips Spectral CT systems with affected software may experience unintended motion of the gantry or table that could lead to contact with operators or patients. Additional software issues may also affect CT performance.

    Product
    Spectral CT. Computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1997-2025·2025-07-02

    Bigfoot Unity Diabetes Management System Pen Caps Unresponsive Due to Firmware Error

    Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.

    Product
    Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2025·2025-07-02

    REMISOL Advance Medical Device Software Defect Affecting Reference Range Calculations

    A software issue in REMISOL Advance may incorrectly process date-of-birth information from laboratory systems, causing incorrect reference range calculations and potentially auto-validating erroneous test result flags. The actual test results are not changed, but their evaluation may be affected.

    Product
    REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2025·2025-07-02

    Barco NexxisOR System Display Encoders and Decoders Recalled

    Barco N.V. is recalling certain NexxisOR system display encoder and decoder models due to duplicate MAC addresses that can cause system malfunction, audio/video interruptions, and delayed procedures when multiple units are deployed together.

    Product
    Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2025·2025-07-02

    Jewel Precision Reusable Rigid Sterilization Container System Instructions Mismatch

    Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2009-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw labeling mismatch recall

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2027-2025·2025-07-02

    Atellica CH Diluent Contaminated with Sodium Hypochlorite

    Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.

    Product
    Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2011-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw package labeling mismatch

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1998-2025·2025-07-02

    LUCAS Chest Compression System demonstration units recalled

    Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression system demonstration units that may have been provided to customers for clinical use instead of demonstration purposes only.

    Product
    LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2025·2025-07-02

    Medline Umbilical Tray sterile packaging defect recall

    Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.

    Product
    Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2025·2025-07-02

    Caphosol Artificial Saliva sachets recalled for out-of-specification stability

    Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.

    Product
    Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2033-2025·2025-07-02

    Jewel Precision Sterilization Container System Recalled for FDA Non-Clearance

    Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1944-2025·2025-06-25

    Dexcom G7 Glucose Receiver recalled due to defective foam or assembly error

    Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.

    Product
    Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1945-2025·2025-06-25

    Dexcom One+ Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.

    Product
    Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1946-2025·2025-06-25

    Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.

    Product
    Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1943-2025·2025-06-25

    Dexcom G6 Glucose Receiver recalled for missed audible alerts

    Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.

    Product
    Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1902-2025·2025-06-25

    Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk

    Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.

    Product
    Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coati
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1987-2025·2025-06-25

    Biomet 3i Certain-Compatible 4.1mm Milled Titanium Dental Abutments

    Preat Corp is recalling Biomet 3i Certain-compatible 4.1mm Milled Titanium Abutments (Model 9001767-F) due to manufacturing defects that may cause improper screw engagement. The screw seat was positioned too high, potentially compromising the attachment of mating screws to the underlying implant.

    Product
    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2025·2025-06-25

    Fitbone Trochanteric Nail may bend during insertion and require replacement

    Orthofix Srl is recalling Fitbone Trochanteric Nails (Lot B4771336 and B4771337) because the implant may bend at the distal tail during insertion, potentially requiring replacement.

    Product
    REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1981-2025·2025-06-25

    UROSKOP Omnia X-ray System Model 10094910 Frequency Inverter Overheating Recall

    Siemens is recalling 95 units of the UROSKOP Omnia X-ray system nationwide due to a resistor in the frequency inverter that may overheat and potentially ignite the plastic housing.

    Product
    UROSKOP Omnia. Model Number: 10094910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2025·2025-06-25

    Fresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks

    Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to potential blood leaks between the venous chamber and tubing. The recall affects hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration procedures nationwide.

    Product
    5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-
    Category
    Medical Device
    Distribution
    Distributed nationwide