The Recall Desk

Hazard

Device Malfunction recalls

877 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device malfunction recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

201–225 of 877

  • ModerateFDA (Devices)·Z-2077-2025·2025-07-09

    ColoSense Test Kit Recall: Quality Control Failure

    Geneoscopy is recalling ColoSense Test Kit, Part No. 80-001, lot 80-001-A2501, because the Low Positive Template Control was out of range, causing multiple plate failures.

    Product
    ColoSense Test Kit, Part No. 80-001, component of ColoSense test
    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-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
  • SevereFDA (Devices)·Z-1867-2025·2025-06-18

    Z-800W Infusion System Recalled for Unverified Software Installation

    Zyno Medical LLC is recalling 613 Z-800W Infusion Systems distributed nationwide after unreleased software versions were installed without verification or validation. The FDA classified this as a Class I recall due to potential safety risks.

    Product
    Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2025·2025-06-18

    DxI 9000 Immunoassay Analyzer Recall Due to Incorrect Motor Installation

    Beckman Coulter is recalling 324 units of the DxI 9000 Access Immunoassay Analyzer due to incorrect motor and cable installation that causes error codes, preventing test performance and delaying results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2025·2025-06-18

    Endoscopic Surgical Blade Assembly Recalled for Unintended Tissue Cutting Risk

    MicroAire's SmartRelease ESTR Onyx Blade Assembly is being recalled because the blade can unintentionally cut tissue before the surgeon deploys it. Healthcare facilities should discontinue use of affected units.

    Product
    Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1755-2025·2025-05-28

    Bard Minnesota Esophagogastric Tamponade Tubes Recalled for Plastic Plug Removal Difficulty

    The FDA recalls Bard Minnesota Esophagogastric Tamponade Tubes due to difficulty removing plastic plugs needed to inflate the therapeutic balloons, which may prevent proper device function.

    Product
    Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-1758-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Difficult Plastic Plug Removal

    C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes due to customer reports of difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1786-2025·2025-05-28

    Cook Incorporated Recalls Check=Flo Performer Introducers for Incorrect Sheath Sizing

    Cook Incorporated is recalling Check=Flo Performer Introducer devices due to potential incorrect introducer sheath sizing that may affect device functionality.

    Product
    Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2025·2025-05-21

    Halyard RAPIDES E-PACK Cardiovascular Kits: Surgical Needle Coating Defect

    AVID Medical is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Kits due to a coating defect on surgical needles that may diminish needle performance during procedures. The defect affects units distributed nationwide in Illinois and Louisiana.

    Product
    Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2025·2025-05-21

    Cook Tornado Embolization Microcoils Recalled for Incorrect Sizing

    Cook Incorporated is recalling Tornado Embolization Microcoils due to incorrect coil sizing. Affected devices may not function properly during vascular procedures.

    Product
    Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1625-2025·2025-05-07

    GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure

    GE Healthcare CARESTATION 620 A2 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode, affecting approximately 1,483 units worldwide. Alternative ventilation modes remain available.

    Product
    GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1636-2025·2025-05-07

    GE Healthcare anesthesia systems recalled for inadequate ventilation in one mode

    Certain GE Healthcare CARESTATION anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode, affecting 217 units distributed worldwide. Effective ventilation remains available through alternative modes.

    Product
    GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2025·2025-05-07

    GE Healthcare Carestation anesthesia systems recalled for ventilation mode failure

    GE Healthcare Carestation anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode, potentially compromising patient safety during anesthesia.

    Product
    GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1634-2025·2025-05-07

    Anesthesia delivery systems recalled for ventilation failure in certain modes

    Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation mode. Operators should use alternative modes (PCV, PCV-VG) or manual ventilation instead.

    Product
    GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2025·2025-05-07

    Cryoablation Needles Recalled for Incorrect Programming Settings

    Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured April 2024 to February 2025 due to DEMO settings instead of COMMERCIAL settings. Affected needles may prompt unexpected re-testing if disconnected and reconnected after initial use.

    Product
    IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1650-2025·2025-04-30

    InPen Smart Insulin Pen Assembly Defect May Prevent Cartridge Use

    Medtronic InPen smart insulin pens may have assembly defects that prevent the insulin cartridge from fitting properly or make it difficult to remove. Users without backup insulin could experience temporary high blood sugar.

    Product
    InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1540-2025·2025-04-16

    Stryker Blueprint Mixed Reality Depth Stop Pin Recalled Due to Device Malfunction

    Tornier S.A.S. is recalling 474 units of the Stryker Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206) due to elevated complaint rates regarding impaired software and instrumentation functioning. The malfunctions prevent the device from meeting its intended use in shoulder surgery guidance.

    Product
    stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1536-2025·2025-04-16

    Stryker Blueprint Coracoid Clamp Guidance System Software and Instrumentation Failures

    Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp due to complaints of impaired software and instrumentation functioning that prevent the system from working as intended. No injuries have been reported.

    Product
    stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1489-2025·2025-04-09

    Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall

    Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.

    Product
    Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1467-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk

    Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2025·2025-04-02

    Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings

    Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.

    Product
    namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk

    The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing s
    Category
    Medical Device
    Distribution
    Distributed nationwide