The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device failure 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.

1–25 of 881

  • SevereFDA (Devices)·Z-2993-2026·2026-09-02

    Medline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk

    Medline is recalling neonatal and infant heated wire breathing circuits due to a risk of sporadic failure and thermal damage at the humidifier connector.

    Product
    Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2864-2026·2026-08-12

    Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece

    Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.

    Product
    STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2906-2026·2026-08-12

    COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling

    TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2901-2026·2026-08-12

    COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.

    Product
    Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2907-2026·2026-08-12

    Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2735-2026·2026-08-05

    ResMed Astral 100/150 Ventilators Recalled Due to Electrolyte Leakage Risk

    ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.

    Product
    Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2807-2026·2026-08-05

    Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522

    Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.

    Product
    EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2827-2026·2026-08-05

    Stryker Hoffmann II Connecting Rod Micro Recalled Due to Potential Cracking

    Stryker is recalling Hoffmann II Connecting Rod Micro 3 x 30mm (catalog 50796030) because the rods may crack after cleaning and sterilization. FDA has classified this as Class II.

    Product
    Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2026·2026-07-29

    Olympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.

    Product
    Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2691-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2607-2026·2026-07-08

    Medline Convenience Kits with Swan-Ganz Catheters Recalled for Defects

    Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing recalled Swan-Ganz catheters may leak or break at the proximal injectate lumen hub, risking infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2641-2026·2026-07-08

    ARTIS icono biplane medical imaging system detector lift malfunction

    Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.

    Product
    ARTIS icono biplane. Model Number: 11327600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2026·2026-07-01

    Stryker Neurovascular INZONE Detachment System battery drain

    Stryker Neurovascular is recalling the INZONE Detachment System (REF: M00345100950) due to premature battery drain that may prevent the device from powering on or detaching coils as intended.

    Product
    INZONE DETACHMENT SYSTEM, REF: M00345100950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2026·2026-07-01

    Surgify Halo Surgical Burrs Recalled Due to Breakage Risk

    SURGIFY MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2213-2026·2026-05-27

    OneLIF Interbody Cage Inserter Attachment Failure Recall

    Novapproach Spine is recalling OneLIF Interbody Cages because the straight inserter may fail to properly attach to the cages, potentially causing procedural delays or the need to use an alternative implant.

    Product
    OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2159-2026·2026-05-20

    NextStep Hemodialysis Catheters with Defective Sheath Introducer

    Arrow International is recalling NextStep Antegrade and Retrograde Hemodialysis Catheters worldwide because an included 16F dual-valved splittable sheath introducer may not split as intended, potentially causing pain, bleeding, hematoma, and tissue injury.

    Product
    NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-1523
    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-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-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
  • CriticalFDA (Devices)·Z-2031-2026·2026-05-06

    Insulin Pump Batteries Recalled After Sudden-Shutdown Reports

    OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1907-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2026·2026-03-04

    Olympus Inner Sheath Medical Device Recall for Ceramic Tip Breakage

    Olympus recalls 91 units of its Inner Sheath Model A4741 medical device after receiving complaints of the ceramic tip breaking during gynecological endoscopic procedures.

    Product
    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking

    Olympus is recalling 1,676 resection sheaths after complaints of ceramic tips breaking during urologic procedures.

    Product
    Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide