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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76–100 of 247

  • 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-1976-2026·2026-05-13

    Halyard NEURO IR PERIPHERAL kit syringe adapter may disconnect

    AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2097-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization issues

    Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.

    Product
    See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2114-2026·2026-05-13

    Medline Surgical Convenience Kits recalled for sterilization calibration defect

    Medline Industries is recalling multiple surgical convenience kits because equipment used to sterilize and package the devices had calibration issues that may have affected sterility assurance. The devices were processed through validated sterilization cycles but the calibration problems could impact their sterility.

    Product
    See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2026·2026-05-13

    Halyard SAMMC Angiography Kit syringe rotating adapter unwinding recall

    Halyard SAMMC ANGIOGRAPHY kits (Model SAMM066-15) are recalled because the Medline syringe rotating adapter may unwind during use, causing a loose or disconnected connection between the syringe and manifold. 2,392 kits were distributed across US states including FL, IL, MO, MS, NC, NE, and TX.

    Product
    Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
    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
  • SevereFDA (Devices)·Z-1936-2026·2026-05-13

    Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands

    Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.

    Product
    Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1972-2026·2026-05-13

    Halyard Cardiac Catheterization Tray Kits Recalled for Connection Risk

    AVID Medical is recalling Halyard CARDIAC CATH TRAY SHANDS JAX kits due to a defect in the Medline syringe rotating adaptor that may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2118-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterility assurance defects

    Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 units distributed nationwide.

    Product
    Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTAN
    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-2108-2026·2026-05-13

    Medline Labor and Delivery Kits Recalled for Sterilization Calibration Issues

    Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.

    Product
    Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2106-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization equipment calibration issues

    Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2063-2026·2026-05-13

    ERBEFLO CleverCap Endoscope Tubing Sets Recalled for Water Aspiration Risk

    Erbe Medical is recalling ERBEFLO CleverCap hybrid tubing and cap sets for endoscopes due to a connector configuration that may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.

    Product
    ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2026·2026-05-13

    LUX-Dx II Plus Arrythmia Detector Software Monitoring Feature Failure

    Boston Scientific's LUX-Dx II Plus implantable cardiac monitors may fail to collect PVC Burden data or monitor for abnormal heart rhythms in some upgraded devices, creating potential gaps in patient monitoring.

    Product
    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2026·2026-05-13

    Medline Arthroscopy Convenience Kits Recalled Due to Sterilization Equipment Calibration

    Medline is recalling five models of arthroscopy convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2026·2026-05-13

    Medline Convenience Kits Surgical Packaging Sterilization Calibration Issue

    Medline Industries is recalling over 7,700 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2026·2026-05-13

    Medline Neurosurgical Convenience Kits Sterilization Calibration Defect

    Medline is recalling 52 models of neurosurgical convenience kits due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2026·2026-05-13

    Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.

    Product
    Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2026·2026-05-13

    Medline PPE Kit recalled for sterilization calibration issues

    Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.

    Product
    Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2026·2026-05-13

    Medline Convenience Kits medical devices recalled due to sterilization calibration issues

    Medline is recalling Convenience Kits (Model DYNJ50806L) because equipment calibration issues may have affected the sterility assurance level of the devices. The products were exposed to sterilization and packaging cycles but the calibration problems could impact their sterility.

    Product
    Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2026·2026-05-13

    Physio-Control Defibrillators May Lack Required Performance Inspection

    Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.

    Product
    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-00193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2026·2026-05-13

    Medline Basic Nerve Block Tray sterilization calibration issue

    Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2026·2026-05-13

    Medline Convenience Kits sterilization and packaging calibration issues recalled

    Medline Industries is recalling multiple Convenience Kit models used in cardiac, vascular, and surgical procedures due to calibration issues with sterilization and packaging equipment that could impact sterility assurance. Approximately 39,341 units distributed worldwide may be affected.

    Product
    Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide