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.

676–700 of 1800

  • HighFDA (Devices)·Z-0117-2023·2022-10-26

    MitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction

    Abbott has recalled MitraClip G4 and TriClip G4 cardiac repair devices due to clip locking malfunctions that may prevent proper device deployment. These malfunctions could lead to failed procedures and serious complications including device embolization.

    Product
    Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriCli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2023·2022-10-26

    MitraClip Clip Delivery System Recalled for Locking Malfunctions

    Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.

    Product
    Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2023·2022-10-26

    Medicina ENFit enteral syringe recall due to material specification defect

    Medicina is recalling ENFit 1ml enteral syringes because the plunger was manufactured with polyethylene instead of approved polypropylene. This material defect could affect plunger function and device safety.

    Product
    Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0086-2023·2022-10-19

    Veritas Advanced Infusion Packs Recalled for Broken Irrigation Luer

    Johnson & Johnson Surgical Vision is recalling 53,624 units of Veritas Advanced Infusion Packs due to manufacturing defects causing broken or cracked irrigation luers that could compromise ophthalmic surgical procedures.

    Product
    Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0042-2023·2022-10-19

    Hobbs Biliary Pigtail Stent Kit Label Bears Incorrect Expiration Date

    Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual product expiration, potentially resulting in use of expired devices.

    Product
    Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0002-2023·2022-10-12

    Ivenix Infusion System LVP Software Display May Freeze Unresponsive

    Fresenius Kabi is recalling the Ivenix Infusion System (IIS) LVP Software version 5.2.0 because the display screen may freeze and become unresponsive, stopping medication flow and requiring immediate clinician intervention.

    Product
    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1856-2022·2022-10-05

    Medline suction catheters recalled due to connector separation risk

    Medline ClearPro Trach Double Swivel Closed Suction Catheters may have the green connector separate from the device during patient suctioning. The recall affects 34,920 units distributed nationwide and internationally.

    Product
    MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2022·2022-10-05

    Olympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction

    Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.

    Product
    Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2022·2022-09-21

    Stryker USB Converter in Mako Robotic Surgery System May Fail

    Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.

    Product
    Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1684-2022·2022-09-14

    Early Bird Bleed Monitoring System Introducer fails to power on

    Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set due to a design error that prevents the device from powering on and completing self-tests. The product was distributed nationwide.

    Product
    Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2022·2022-09-07

    Boston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall

    Boston Scientific is recalling ZOOM LATITUDE programmers due to potential software anomalies that could affect communication with implantable defibrillators. No injuries have been reported.

    Product
    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1647-2022·2022-09-07

    Siemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure

    Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.

    Product
    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1560-2022·2022-08-31

    Getinge Servo ventilator systems recalled for loss of ventilation

    Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.

    Product
    Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1525-2022·2022-08-31

    Intensive care ventilator status board may loosen, causing water damage and malfunction

    Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.

    Product
    HAMILTON-C6 Intensive Care Ventilator, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2022·2022-08-31

    3M Grounding Safety Ring Pads Recalled Due to Temperature Exposure

    3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.

    Product
    3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1485-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy

    Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1488-2022·2022-08-17

    Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy

    Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators may deliver reduced shock energy

    Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.

    Product
    Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1502-2022·2022-08-10

    UroLift System recalled for potential implant deployment failure

    Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.

    Product
    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1482-2022·2022-08-10

    PRESTIGE RETRACTION GRASPER recalled due to potential weld separation

    The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument due to risk of weld separation between the handle and shaft. This defect could cause device malfunction during surgical procedures.

    Product
    PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2022·2022-08-03

    TruClear Hysteroscopic Tissue Removal Control Unit Electrical Failure

    Covidien is recalling 33 TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure causing loss of device function during surgery. The affected units were distributed to multiple U.S. states and foreign countries.

    Product
    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1405-2022·2022-07-27

    Surgical Coronal Bender May Deform Spinal Implants During Surgery

    Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.

    Product
    RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1417-2022·2022-07-27

    Hill-Rom Centrella Pro+ surface mattress microclimate management feature failure

    Baxter Healthcare is recalling Hill-Rom Centrella Pro+ surface mattresses due to a potential Microclimate Management feature failure that may increase the risk of pressure ulcer development.

    Product
    Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1414-2022·2022-07-27

    Hill-Rom Hospital Mattress Surfaces Recalled for Pressure Ulcer Risk

    Baxter Healthcare is recalling 202 Hill-Rom PRO+ mattress surfaces. The microclimate management feature may malfunction, reducing the product's ability to manage heat and moisture, which increases the risk of patient pressure ulcers.

    Product
    Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2022·2022-07-20

    Modular orthopedic prosthesis recall due to intraoperative component locking

    Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.

    Product
    Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
    Category
    Medical Device
    Distribution
    15 states