The Recall Desk

Hazard

Device Malfunction recalls

1,813 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,813
Critical
31
Severe
463
Most recent
2026-10-21

Of the 1,813 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 463 (26%) are Severe.

Which agencies issued them

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.

26–50 of 1813

  • ModerateFDA (Devices)·Z-2775-2026·2026-07-29

    SnapshotGLO Wound Imaging Device Recalled Due to Battery Charging Software Issue

    Kent Imaging, Inc. is recalling SnapshotGLO Wound Imaging Devices (Models KB100 and KB100AA) because software issues may prevent the device from recharging.

    Product
    SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2689-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2026·2026-07-08

    ARTIS icono floor Medical Imaging System Detector Movement Loss Recall

    Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum height limits.

    Product
    ARTIS icono floor. Model Number: 11327700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2026·2026-07-08

    Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

    Medline is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2026·2026-07-08

    IntelliCuff Portable Automatic Cuff Pressure Controller Recall

    Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.

    Product
    IntelliCuff, Portable automatic cuff pressure controller REF: 951001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2026·2026-06-24

    ConMed AirSeal 12mm access ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 891 packs, or 5,346 units, are affected.

    Product
    ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 150mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 150 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2026·2026-06-24

    ConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Low Profile Bladeless Optical Tip Obturators are being recalled because of the potential for overpressure alerts. 71,151 packs affected.

    Product
    ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2474-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2026·2026-06-24

    ConMed AirSeal 8mm 120mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2026·2026-06-24

    ConMed AirSeal 5mm smooth access ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Smooth Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 497 packs, or 2,982 units, are affected.

    Product
    ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2026·2026-06-24

    ConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip, 100 mm length, are being recalled because of the potential for overpressure alerts. 1,261 packs affected.

    Product
    ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2026·2026-06-24

    ConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2026·2026-06-24

    ConMed AirSeal 5mm 120mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2026·2026-06-24

    ConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2026·2026-06-24

    ConMed AirSeal 5mm 75mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 75 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2413-2026·2026-06-17

    Orca single use endoscope valves recalled over sticking suction buttons

    Boston Scientific is removing Orca Sterile, Single Use Air/Water and Suction Valves because of a higher than anticipated occurrence of the suction button sticking. 9,750 units affected.

    Product
    Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2026·2026-05-27

    Integris-Allura X-ray systems with degraded deaeration hoses recalled

    Philips is recalling Integris-Allura X-ray systems because deaeration hoses in X-ray tube cooling units may degrade, causing oil leakage that reduces cooling performance and triggers a system shutdown to low-dose mode.

    Product
    Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2026·2026-05-27

    Philips Azurion X-Ray Systems Table Movement Control Defect Recall

    Philips Azurion X-ray imaging systems may experience impaired table movement due to mechanical wear in the Float Tabletop control. The control module defect could affect longitudinal and transverse table positioning during medical procedures.

    Product
    Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2142-2026·2026-05-20

    Namic Preceptor Manifold extravascular blood pressure transducer

    Medline is recalling the Namic Preceptor Manifold due to particulate matter found in the fluid path. The recall affects 760 units distributed in the US and eight other countries.

    Product
    Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2141-2026·2026-05-20

    Namic Preceptor Manifold blood pressure transducers recalled for particulate contamination

    Medline Industries is recalling Namic Preceptor Manifold extravascular blood pressure transducers due to the presence of particulate matter within the fluid path. The recall affects 6,390 units distributed nationwide in the US and internationally.

    Product
    Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2157-2026·2026-05-20

    Arrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer

    Arrow International is recalling Arrow-Clark VectorFlow hemodialysis catheters due to a supplier defect in the sheath introducer that may fail to split properly, potentially causing withdrawal resistance, prolonged procedures, pain, bleeding, and tissue injury.

    Product
    Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI…
    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-2137-2026·2026-05-20

    DonJoy IceMan cold therapy unit recall due to broken connector

    DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (model 11-9099) due to a broken connector that may interrupt prescribed cold therapy. The affected unit is lot 110525, distributed across the US and Canada.

    Product
    Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide