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.

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326–350 of 28523

  • HighFDA (Devices)·Z-2163-2026·2026-05-20

    Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts

    Dexcom, Inc. is recalling versions 2.9.0 through 2.11.2 of the Dexcom G7 Continuous Glucose Monitoring iOS app due to a software defect that delays glucose value notifications and alerts, risking missed detection of dangerous blood sugar events.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling 217 units of BARD EP XT Decapolar Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2026·2026-05-20

    Medtronic SynchroMed Flex Infusion Programmer Software Application

    Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.

    Product
    Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2197-2026·2026-05-20

    Daig Livewire Steerable Reprocessed Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling 458 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recall Due to Incomplete Seals

    Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2026·2026-05-20

    [pending] Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App

    Pending LLM rewrite. Source: FDA_DEVICE Z-2164-2026.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2026·2026-05-20

    Daig Livewire Steerable Reprocessed Electrophysiology Catheters Recalled

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging. The defect may compromise sterility.

    Product
    Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which could compromise sterility.

    Product
    BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Daig Livewire Steerable recalled

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product. The recall affects 19 units distributed nationwide in the US, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2026·2026-05-20

    Dexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts

    Dexcom, Inc. is recalling Dexcom ONE+ iOS CGM App versions 1.5.0 and 1.6.0 due to a software defect that can delay glucose alerts and notifications, risking delayed detection of low or high blood sugar events.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling 154 units of BW Webster Duo-Decapolar reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.

    Product
    BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheters Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable electrophysiology catheters with incomplete seals on sterile packaging. The defect may allow contamination of the sterile product.

    Product
    Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2026·2026-05-20

    Edwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality

    Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.

    Product
    Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2154-2026·2026-05-20

    Revolution Apex X-ray CT System Security Vulnerability Recall

    GE HealthCare is recalling Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link-based CT Smart Subscription. The vulnerability may impact system security.

    Product
    Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2026·2026-05-20

    Revolution CT X-ray Computed Tomography System Security Vulnerability Recall

    GE HealthCare is recalling Revolution CT x-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The vulnerability affects certain Revolution Apex, Revolution Ascend, and Revolution CT systems worldwide.

    Product
    Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2026·2026-05-20

    Buprenorphine Hydrochloride Injection Recall Due to Particulate Matter

    Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2171-2026·2026-05-20

    ZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values

    Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.

    Product
    ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2026·2026-05-20

    Revolution CT ES X-ray Computed Tomography System Security Vulnerability Recall

    GE Medical Systems is recalling Revolution CT ES and related CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link based CT Smart Subscription. The vulnerability may affect system security.

    Product
    Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2166-2026·2026-05-20

    Thermedx FluidSmart Urology Tube Set recalled for nonconforming products

    Stryker Corporation is recalling the Thermedx FluidSmart Urology Tube Set (Catalog No. LL0006) due to nonconforming products that were inadvertently distributed. The affected tube sets were distributed nationwide in Georgia.

    Product
    Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warmi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2149-2026·2026-05-20

    Revolution Ascend CT scanner security vulnerability affecting AW Server

    GE HealthCare is recalling Revolution Ascend computed tomography systems due to a potential security vulnerability in the AW Server used with Edison Health Link-based CT Smart Subscription. 25 units are affected nationwide.

    Product
    Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
    Category
    Medical Device
    Distribution
    Distributed nationwide