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.

76–100 of 877

  • HighFDA (Devices)·Z-1375-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recalled Due to Adverse Event Reports

    Olympus has initiated a removal of Thunderbeat 5 mm surgical devices following continued reports of adverse events. The affected devices were distributed worldwide, including throughout the United States.

    Product
    Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2026·2026-02-25

    Olympus Thunderbeat Device Recalled Due to Adverse Events

    Olympus Corporation of the Americas is recalling the Olympus Thunderbeat 5 mm, 35 cm device due to continued adverse event reports. Approximately 88,268 units are affected across worldwide distribution.

    Product
    Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Removal Due to Adverse Events

    Olympus Corporation is removing Thunderbeat surgical instruments worldwide due to continued reports of adverse events. The 5 mm, 45 cm pistol grip devices affected include all manufacturing lots.

    Product
    Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Instrument Recall Due to Adverse Events

    Olympus is recalling approximately 1,538 Thunderbeat surgical instruments due to continued reports of adverse events. Affected devices are being removed from distribution.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2026·2026-02-18

    Philips Azurion 3 M15 System Patient Table May Move Unexpectedly

    Philips is recalling the Azurion 3 M15 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when locked. This poses a patient safety hazard during interventional procedures.

    Product
    Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2026·2026-02-18

    Philips Azurion 7 M12 Imaging System Table Unexpected Movement Risk

    Philips has recalled the Azurion 7 M12 imaging system because the examination table may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is active. This could pose a patient safety risk.

    Product
    Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2026·2026-02-11

    Molift Mover 300 mobile hoist recalled for bolt deformation defect

    ETAC A/S recalls Molift Mover 300 mobile hoists due to bolt deformation in the lifting bar joint that can prevent proper device functionality.

    Product
    Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1288-2026·2026-02-11

    Olympus Disposable Triple Lumen Sphincterotome devices recalled for deformation risk

    Olympus recalls Disposable Triple Lumen Sphincterotome Model KD-401Q-0720 devices due to manufacturing defects that could cause device deformation and loss of performance during medical procedures.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2026·2026-02-11

    Molift 2-Point Sling Bars Recalled for Structural Bolt Failure

    ETAC A/S is recalling Molift 2-point sling bars due to bolts breaking during assembly and testing. The defect causes material deformation that prevents proper functionality in this assistive device.

    Product
    Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2026·2026-02-11

    Prostate Imaging Device Focalyx Fusion May Malfunction with Windows 10

    Focalyx Fusion prostate imaging devices may not work properly on Windows 10, risking patient harm during biopsy or treatment delays. The manufacturer recommends stopping use until Windows 11 compatibility is verified.

    Product
    Focalyx Fusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2026·2026-02-11

    Single Use 3-Lumen Sphincterotome Recalled Due to Manufacturing Defect

    Olympus Corporation is recalling Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Some devices did not undergo thermoforming and could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2026·2026-02-11

    Olympus Sphincterotome Devices May Deform Due to Manufacturing Defect

    Olympus is recalling Single Use 3-Lumen Sphincterotomes that may deform if not properly thermoformed during manufacturing, potentially losing performance during use. No illnesses have been reported.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2026·2026-02-11

    Olympus Sphincterotome Defective Units Recalled for Potential Device Deformation

    Olympus is recalling CleverCut Single Use 3-Lumen Sphincterotomes (Model KD-V411M-0320) because some units may not have undergone proper thermoforming, potentially causing device deformation and performance loss.

    Product
    Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2026·2026-02-11

    FDA Recalls Single Use Sphincterotome Due to Deformation Risk

    Olympus is recalling Single Use 3-Lumen Sphincterotome V instruments (Model KD-V411M-3020) because some devices may not have undergone proper thermoforming, causing potential deformation and performance loss. The recall affects 650 units.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2026·2026-02-11

    Dialyzer deaeration chamber may dislodge from control unit

    VANTIVE US HEALTHCARE is recalling 115,112 PRISMAFLEX HF1000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.

    Product
    PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2026·2026-02-11

    OXIRIS Dialyzer Set Recalled Due to Potential Deaeration Chamber Dislodgement

    VANTIVE US HEALTHCARE LLC is recalling 2,724 units of OXIRIS SET dialyzers nationwide due to potential dislodgement of the deaeration chamber, which could impair device function.

    Product
    OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2026·2026-02-04

    Medical x-ray system suspension screws may loosen, impairing device function

    The Alphenix INFX-8000C x-ray system's ceiling suspension screws may become loose, preventing lateral movement and causing sensor errors. 172 units distributed in the US and Dominican Republic are affected.

    Product
    Alphenix INFX-8000C, interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2026·2026-02-04

    Medline C-section procedure kits recalled for defective adhesive tubing

    Medline C-section procedure kits are recalled because the MASTISOL liquid adhesive they contain has butyrate tubing that cracks during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2026·2026-02-04

    Medline Medical Procedure Kits Recalled for Defective Tubing

    Medline is recalling three types of medical procedure kits containing MASTISOL liquid adhesive with defective tubing that cracks during use. Approximately 1,928 units were distributed nationwide.

    Product
    Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2026·2026-02-04

    Medline Cardiac Procedure Kits Recalled Due to Cracking Tubing in Adhesive Vials

    Medline Industries recalls eight medical procedure kits nationwide due to MASTISOL liquid adhesive vials with cracking butyrate tubing. The defect could affect proper device function during cardiac and vascular procedures.

    Product
    Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2026·2026-01-28

    Merit Medical Custom Inflation Kit handle detachment during medical procedure

    Merit Medical is recalling 18,897 Custom Inflation Kits because the inflation device handle may detach from the syringe during use, potentially affecting device function.

    Product
    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2026·2026-01-28

    Merit Medical Vascular Waste Kit Inflation Handle May Detach During Procedure

    Merit Medical Custom Waste Management Kit Vascular Tray inflation device handles may detach from syringes during medical procedures. This Class II recall affects 864 units distributed worldwide.

    Product
    Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2026·2026-01-28

    EDAN Patient Monitors Recalled for Cybersecurity Vulnerabilities

    Edan Diagnostics is recalling EDAN iX series patient monitors (models iX10, iX12, iX15) due to potential cybersecurity vulnerabilities identified by the FDA.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2026·2026-01-28

    EDAN M3B Vital Signs Monitor Recalled for Potential Cybersecurity Issues

    The FDA is recalling EDAN M3B Vital Signs Monitors due to potential cybersecurity vulnerabilities. Approximately 354 units were distributed in hospitals across the U.S. and Mexico.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2026·2026-01-21

    Medline IV Administration Kits Recalled for Check Valve Sticking Risk

    Medline is recalling IV administration kits containing B. Braun components due to check valve defects that may become stuck. The kits were distributed nationwide and used in anesthesia procedures.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
    Category
    Medical Device
    Distribution
    Distributed nationwide