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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51–75 of 247

  • 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-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-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-2199-2026·2026-05-20

    Reprocessed Medtronic Marinr Steerable Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling 87 units of the Medtronic Marinr Steerable reprocessed electrophysiology catheter (Product Number 72402) due to incomplete seals on the sterile product.

    Product
    Medtronic Marinr Steerable, Product Number 72402; 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-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-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-2193-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall

    Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed in the US, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2026·2026-05-20

    BARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200131) due to incomplete seals on sterile product packaging. The recall affects 61 units distributed nationwide in the US and in Israel and Canada.

    Product
    BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2182-2026·2026-05-20

    BARD EP XT Steerable Reprocessed Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.

    Product
    BARD EP XT Steerable, Product Number 200794; 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-2198-2026·2026-05-20

    Daig Livewire Steerable BDB Electrophysiology Catheter Recall

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

    Product
    Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.

    Product
    BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2026·2026-05-20

    BARD Dynamic Tip Steerable Medical Device Recall Due to Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable devices due to incomplete seals on the sterile product. The recall affects 427 units distributed nationwide and in Israel and Canada.

    Product
    BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.

    Product
    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1934-2026·2026-05-13

    Cook Centimeter Sizing Catheter recall due to marker band cracking

    Cook Incorporated is recalling Centimeter Sizing Catheters because marker bands may crack or break, potentially causing device fragmentation, vessel injury, or life-threatening harm.

    Product
    Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1935-2026·2026-05-13

    Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk

    Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.

    Product
    Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2064-2026·2026-05-13

    Endoscopy Pump Tubing/Cap Set water aspiration risk recall

    Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Sets due to a connector design that may allow unintended water flow, potentially leading to water aspiration and serious respiratory conditions.

    Product
    ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2007-2026·2026-05-13

    Medical Action Industries Pack Cath BHH Catheter Kit Recall

    Medical Action Industries is recalling Pack Cath BHH catheter kits because the rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2091-2026·2026-05-13

    Medline Convenience Kits Recalled for Sterilization Calibration Issues

    Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.

    Product
    Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1942-2026·2026-05-13

    VOCSN V+Pro Ventilator System Respiratory Device Safety Recall

    Ventec Life Systems is recalling VOCSN V+Pro ventilator units because they may not have been fully tested for high-pressure conditions, which could cause oxygen leaks and increase fire risk during use.

    Product
    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1975-2026·2026-05-13

    Halyard HEART CATH SELF REGIONAL kit syringe adapter disconnection hazard

    AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1971-2026·2026-05-13

    Halyard CARDIAC CATH PACK SAN23CARDQ Kit Syringe Adapter Risk

    AVID Medical is recalling Halyard CARDIAC CATH PACK SAN23CARDQ kits (Model DRCC36) due to a Medline syringe rotating adapter that may unwind during use, potentially causing loose or full disconnection between the syringe and manifold.

    Product
    Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1973-2026·2026-05-13

    Halyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk

    AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75AM) because the syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard CATH LAB kit. Model Number: SACL75AM.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1979-2026·2026-05-13

    Halyard VA Detroit Cath Lab Pack Kit Syringe Adaptor Disconnection Risk

    Halyard VA Detroit Cath Lab Pack kits (Model VMCD029) are being recalled due to a potential risk that the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
    Category
    Medical Device
    Distribution
    7 states