The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 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 370 (21%) 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.

401–425 of 1800

  • HighFDA (Devices)·Z-1691-2024·2024-05-08

    Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram

    Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.

    Product
    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1613-2024·2024-05-01

    Route 92 Medical delivery catheter recalled due to tip separation risk

    Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.

    Product
    Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1603-2024·2024-05-01

    Proton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation

    IBA Proton Therapy System (PROTEUS 235) units recalled due to safety parameter failures that could prevent proper radiation control, risking unintended radiation exposure during cancer treatment.

    Product
    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1519-2024·2024-04-24

    SonarMed 2.5mm Airway Sensor Recalled for Obstruction Detection Failure

    SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.

    Product
    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1540-2024·2024-04-24

    Smiths Medical Medfusion Syringe Pumps May Fail to Recognize Syringes

    Smiths Medical is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps due to a barrel clamp guide defect. The defect may prevent the pump from recognizing or correctly identifying a syringe, potentially affecting medication delivery.

    Product
    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1537-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring

    Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2024·2024-04-17

    PEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement

    Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.

    Product
    EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2024·2024-04-10

    Covidien Auto Suture Blunt Tip Trocar recalled for seal disengagement

    Covidien is recalling approximately 11,796 Auto Suture Blunt Tip Trocar units due to potential seal disengagement when mesh products are used incorrectly with the device. The issue could occur during surgical procedures.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2024·2024-04-10

    Signia Surgical Stapler Reload recalled for uncontrolled articulation

    Covidien is recalling Signia Small Diameter Curved Tip Intelligent Reload surgical stapler reloads due to potential malfunction that could disrupt the staple line during use. The affected reloads may articulate uncontrollably due to unsecured components.

    Product
    Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2024·2024-04-10

    Skull Anchor Key Defect Prevents CT Localizer Attachment

    Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.

    Product
    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2024·2024-04-10

    Covidien Auto Suture Blunt Tip Trocar Recalled for Seal Disengagement Risk

    Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2024·2024-04-03

    Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak

    Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.

    Product
    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2024·2024-04-03

    Epix Universal Clip Applier Recalled for Potential Clip Loading Failure

    Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.

    Product
    Epix Universal Clip Applier, REF: CA500, STERILEEO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2024·2024-04-03

    Medivance Neonatal ArcticGel Pads Recalled for Reduced Water Flow

    Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.

    Product
    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2024·2024-04-03

    Olympus Insufflation Unit UHI-4 Recalled for Air Supply Failure

    Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.

    Product
    Insufflation unit, UHI-4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2024·2024-03-27

    MINI STICK MAX guidewire introducer defect may prevent sheath passage during procedures

    Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2024·2024-03-27

    Directional Laser Probe Recalled for Fiber Extension and Direction Failure

    D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.

    Product
    Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2024·2024-03-27

    Vascular Guidewire Introducer Recalled Due to Internal Hub Defect

    A vascular guidewire introducer is recalled because internal voids in the hub may prevent proper guidewire passage, potentially delaying surgical procedures.

    Product
    MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2024·2024-03-27

    Directional Laser Probe Recall Due to Fiber Extension and Direction Malfunction

    A Class II medical device recall has been issued for Directional Laser Probes due to potential difficulties extending, retracting, and directing the laser fiber tip. The issue affects 126 units distributed across multiple US states.

    Product
    Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2024·2024-03-27

    Guidewire Introducer Recalled for Manufacturing Defect Affecting Device Function

    Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.

    Product
    MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2024·2024-03-27

    Vascular guidewire introducer recalled for manufacturing defect

    Angiodynamics recalls MINI STICK MAX vascular guidewire introducers due to internal lumen defects that may prevent the guidewire from passing through during surgery, potentially requiring device exchange.

    Product
    MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2024·2024-03-27

    Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect

    Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2024·2024-03-27

    Directional Laser Probe Recalled for Fiber Extension and Direction Difficulties

    D.O.R.C. Dutch Ophthalmic Research Center is recalling Directional Laser Probes for ophthalmic surgery due to difficulties extending, retracting, and directing the laser fiber. The recall affects 84 units distributed nationwide.

    Product
    Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1346-2024·2024-03-27

    Guidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect

    Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1336-2024·2024-03-27

    FDA Recalls Vascular Guidewire Introducer Due to Manufacturing Defect

    Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.

    Product
    MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
    Category
    Medical Device
    Distribution
    Distributed nationwide