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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2901–2925 of 13446

  • HighFDA (Devices)·Z-1995-2025·2025-07-02

    Medline umbilical catheter tray recalled for outer packaging defect

    Medline is recalling its UMBILICAL TRAY W/3.5&5FR CATH due to a possible packaging defect in the outer Tyvek pouch. The defect could compromise the sterile protection of the product.

    Product
    Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2025·2025-07-02

    Shoulder Replacement Screw Labeling Does Not Match Product Size

    Encore Medical is recalling ALTIVATE REVERSE TORX PERIPHERAL SCREW surgical components because package labeling lists a different size than what is actually included. The mismatch could result in selection of an incorrectly sized component during shoulder replacement surgery.

    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
  • HighFDA (Devices)·Z-2017-2025·2025-07-02

    Software error in BD Pyxis cabinets can delay medication dispensing

    BD Pyxis medication dispensing cabinets may experience a software error during installation that prevents user access to the medication application, potentially delaying access to patient medications and supplies.

    Product
    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2025·2025-07-02

    Becton Dickinson TB susceptibility test kit recalled for intermittent false results

    Becton Dickinson is recalling the BD BACTEC MGIT 960 PZA Kit, a tuberculosis drug-resistance test, due to intermittent false resistance results. Approximately 12,256 units were distributed worldwide.

    Product
    BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2025·2025-07-02

    Medical device software defect affecting laboratory result validation and reference ranges

    REMISOL Advance laboratory data management system has a software bug that incorrectly identifies patients as newborns when date of birth is empty or set to 01/01/1900, potentially affecting result validation and reference range calculations.

    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-2009-2025·2025-07-02

    Shoulder Replacement Screws Recalled for Package Size Mislabeling

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws used in shoulder replacement surgery because the package labeling indicates a different size than the product it contains.

    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
  • HighFDA (Devices)·Z-2000-2025·2025-07-02

    BD Insyte Autoguard IV Catheter Needle May Fail to Retract

    Becton Dickinson is recalling BD Insyte Autoguard BC IV catheters because the needle may retract slowly or fail to retract completely, creating a needlestick injury risk. The affected units were distributed worldwide.

    Product
    REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2025·2025-07-02

    Integra MicroMyst Applicator recalled worldwide for sterility deficiency

    Integra LifeSciences' MicroMyst Applicator has been recalled worldwide due to lack of sterility assurance affecting approximately 4,882 units.

    Product
    MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2025·2025-07-02

    Ultrasound Systems May Display Previous Patient Data in Reports

    GE Healthcare Versana ultrasound systems may display previous obstetric patient data in fetal weight reports, potentially causing incorrect clinical decisions about fetal size and growth.

    Product
    GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2034-2025·2025-07-02

    Philips Spectral CT Computed Tomography Systems Recall: Software Motion Issues

    Philips has recalled 370 Spectral CT computed tomography systems due to software issues that may cause unintended motion of the gantry or table, potentially resulting in contact with patients or operators.

    Product
    Spectral CT. Computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2004-2025·2025-07-02

    BD Insyte Autoguard BC Pro IV Catheter Needle Retraction Failure Recall

    BD Insyte Autoguard BC Pro IV catheters are being recalled because the needle may be slow to retract or fail to retract completely, based on customer complaints.

    Product
    REF: 381811, 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-2027-2025·2025-07-02

    Atellica CH Diluent Recalled Due to Sodium Hypochlorite Contamination

    Siemens is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect calibrator, quality control, and patient test results. The recall affects 1,625 units distributed in the United States, Canada, and the Bahamas.

    Product
    Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2025·2025-07-02

    Operating room display components recalled for duplicate MAC address configuration issue

    Barco NexxisOR surgical system encoder and decoder components can fail to function reliably when multiple units share the same MAC address, potentially interrupting audio, video, and control signals. The recall affects 221 units in Texas and Ohio.

    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
  • HighFDA (Devices)·Z-2010-2025·2025-07-02

    Altivate Reverse shoulder implant screw package labeling mismatch FDA recall

    Altivate Reverse Torx Peripheral Screw packages are labeled with incorrect size information. The included product may differ from the labeled size, posing risks if implanted in error.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 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
  • HighFDA (Devices)·Z-2008-2025·2025-07-02

    ALTIVATE Reverse shoulder screw package labeled with incorrect size

    Encore Medical is recalling ALTIVATE REVERSE TORX PERIPHERAL SCREWS due to packaging labeling errors. The label indicates one screw size, but the actual product included is a different size than stated.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 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
  • HighFDA (Devices)·Z-2006-2025·2025-07-02

    BD Insyte Autoguard IV catheter needle retraction slow or failure

    BD Insyte Autoguard IV catheters (Lot# 4282308) may have slow or failed needle retraction. Affected units distributed worldwide; healthcare providers should quarantine remaining stock.

    Product
    REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2025·2025-07-02

    Thermistor Assembly Error in CDI OneView BPM Probe Causes Measurement Inaccuracy

    Terumo is recalling CDI OneView BPM Probes due to a thermistor assembly error that causes inaccuracy in temperature and blood gas measurements. Inaccurate readings may lead to inappropriate medical 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-2003-2025·2025-07-02

    BD Insyte IV Catheter Needle Retraction Defect Recalled

    BD Insyte Autoguard BC Pro Winged Shielded IV catheters (18 GA, Lot 4298108) are being recalled due to a defect where the needle may be slow to retract or fail to retract entirely. The affected units were distributed worldwide.

    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-2001-2025·2025-07-02

    BD Insyte IV Catheter Needle Retraction Failure Recall

    Becton Dickinson is recalling BD Insyte Autoguard IV catheters (Lot 4282452) because the needle may retract slowly or fail to retract completely. This poses a potential needlestick injury risk.

    Product
    REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2025·2025-07-02

    Diabetes Management System Firmware Issue May Disable Insulin Pen Functionality

    Bigfoot Unity Diabetes Management System pen caps may become unresponsive due to firmware issues, preventing insulin delivery. The FDA Class II recall affects 57 units.

    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-2016-2025·2025-07-02

    Omnipod 5 iOS App Decimal Separator Bug May Cause Insulin Over-delivery

    Insulet Corporation is recalling Omnipod 5 iOS App due to a software bug where decimal separators are not recognized in certain regions, which may cause insulin over-delivery and hypoglycemia.

    Product
    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2002-2025·2025-07-02

    BD Insyte Autoguard IV Catheter Needle Retraction Failure Recalled

    FDA is recalling BD Insyte Autoguard Shielded IV Catheters (Lot 4290664) due to possible needle retraction failure. The safety shield may not fully retract, creating potential needlestick risk.

    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
  • ModerateFDA (Devices)·Z-2033-2025·2025-07-02

    Jewel Precision Sterilization Container System Recalled for Inadequate FDA Clearance

    Jewel Precision is recalling its 8-inch JP-24-8 sterilization container system (Lot 16899) because it was not cleared by the FDA due to insufficient documentation of the size change. No illnesses or injuries have been reported.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2024-2025·2025-07-02

    PRIMA 2mm Eccentrical Adaptor Screw: Missing Positioning Laser Marking Recall

    Limacorporate is recalling PRIMA 2mm eccentrical adaptors because the black laser marking used to identify position may be missing on some units. No injuries have been reported.

    Product
    PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2025·2025-07-02

    Caphosol Artificial Saliva Recalled for Out-of-Specification Stability Test Results

    RECORDATI RARE DISEASES INC. is recalling Caphosol Artificial Saliva because the B solution component failed stability testing. The issue was detected during process validation and may affect product efficacy.

    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