The Recall Desk

Hazard

Device Failure recalls

240 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 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.

26–50 of 240

  • SevereFDA (Devices)·Z-0590-2026·2025-12-17

    Draeger ErgoStar CM 40 airway connectors recalled for hose cracks

    Draeger is recalling 14,420 ErgoStar CM 40 airway connectors worldwide due to cracks forming in the connector hose, which could compromise respiratory gas delivery to mechanically ventilated patients.

    Product
    ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0430-2026·2025-11-26

    BD Alaris Infusion Pump Module 8100 Recall: Risk of Malfunction if Dropped

    CareFusion recalls BD Alaris infusion pump modules distributed worldwide. Dropping or jarring may damage the bezel assembly, causing under-infusion, over-infusion, or pump failure; affected pumps must be removed from service and inspected by qualified personnel.

    Product
    BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2026·2025-11-19

    ShockPulse Lithotripsy Transducer may fail to operate or overheat

    Olympus is recalling the ShockPulse Lithotripsy Transducer because the device may fail to start or stop unexpectedly, and the handpiece may overheat during use. Healthcare providers should discontinue use of affected units.

    Product
    Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2026·2025-10-29

    Salem Sump Anti-Reflux Valve May Break During Use

    Cardinal Health is recalling Salem Sump Anti-Reflux Valves due to reports of valve breakage during use. The company is providing additional guidance to address the issue.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2026·2025-10-08

    Imaging device may fail to start due to BIOS battery depletion

    The Allura Xper CV20 device may fail to start if the BIOS battery depletes faster than expected. No warning message is shown before the battery becomes low or depleted.

    Product
    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2026·2025-10-08

    Medical Imaging System May Fail to Start Due to Battery Depletion

    Philips Allura Xper FD20/20 fluoroscopy systems may experience premature BIOS battery depletion, preventing system startup without prior warning. 115 units distributed worldwide are affected.

    Product
    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2025·2025-09-24

    Vercise Deep Brain Stimulation Systems Recall Due to Wire Breaks

    Boston Scientific is recalling Vercise Deep Brain Stimulation Systems due to wire breaks in implanted pulse generators that prevent therapy. Device removal and replacement is typically required.

    Product
    Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2450-2025·2025-09-10

    Dexcom G7 and ONE+ Glucose Monitoring App Misses Sensor Failure Alert

    Dexcom's G7 and ONE+ CGM apps fail to alert users when the sensor fails. Instead of notifying the user, the app silently ends monitoring, potentially delaying treatment of dangerous blood sugar extremes.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2025·2025-09-10

    Superion Indirect Decompression System spinal implants recalled for device breakage

    Boston Scientific recalls Superion Indirect Decompression System spinal implants due to device and instrument breakage affecting performance.

    Product
    Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2025·2025-09-10

    Sterile Cover Surgical Device Recalled for Risk of Elastic Band Detachment

    Lumicell's sterile surgical covers are being recalled because elastic bands may detach or fracture during surgery, potentially leaving foreign bodies in the surgical site and causing infection. The recall affects 200 units in CA, FL, MA, NC, and TX.

    Product
    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2025·2025-09-10

    Defibrillator servicing inspections not performed; Physio-Control LIFEPAK CR2 recalled

    Physio-Control is recalling LIFEPAK CR2 defibrillators due to failure to perform required inspections on serviced units. Affected units were distributed in Colorado and Montana.

    Product
    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2327-2025·2025-08-27

    Defibrillator leads recalled for calcification risk and potential device failure

    Multiple models of RELIANCE 4-FRONT defibrillator leads may develop calcification, leading to device failure and potential cardiac emergencies.

    Product
    RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2326-2025·2025-08-27

    Defibrillation lead recalled due to calcification and device failure

    Boston Scientific recalls ENDOTAK RELIANCE defibrillation leads that may calcify over time, potentially requiring early replacement and posing cardiac risk.

    Product
    ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2325-2025·2025-08-27

    Defibrillation Leads Risk Early Replacement From Coil Calcification

    Boston Scientific's ENDOTAK RELIANCE defibrillation leads may develop coil calcification causing gradually rising electrical impedance measurements. This condition may require early lead replacement; most serious outcomes include cardiac emergency or death.

    Product
    ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2102-2025·2025-07-23

    i-view Video Laryngoscope Recalled Due to Depleted Battery Risk

    Intersurgical Inc is recalling the i-view video laryngoscope (Model 8008000) due to the potential for faulty devices caused by depleted batteries. A total of 2,152 affected units were distributed across the United States.

    Product
    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2055-2025·2025-07-09

    Philips L12-4 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips is recalling 5,230 L12-4 ultrasound transducers that were refurbished beyond their design lifespan. Devices beyond useful life may experience performance degradation or failure.

    Product
    Philips L12-4 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2025·2025-04-16

    Stryker Blueprint Mixed Reality Surgical Instrument Kit Fails to Function Properly

    Stryker is recalling the Blueprint Mixed Reality Instrument Kit for shoulder surgery due to elevated complaints of software and hardware failures that prevent proper use.

    Product
    stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1288-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Plastic Housing May Separate

    The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1405-2025·2025-03-26

    CAPNOCHECK Airway Adapter May Break Off, Risking Ventilation Loss

    CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

    Product
    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2025·2025-03-19

    Stryker CinchLock anchor recalled due to pullwire breakage

    Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.

    Product
    Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions

    ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2025·2025-03-19

    Multiple Aesculap Surgical Forceps Models Recalled for Clamp Breakage

    Aesculap Inc is recalling 93,714 hemostatic forceps across 83 models due to clamp breakage that occurs when forceps are used in ways not covered by the design.

    Product
    Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forceps Curved 250MM; (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM; (5) REF BJ020R, Ove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2025·2025-03-19

    Aesculap hemostatic forceps recalled due to clamp breakage

    Aesculap is recalling 47,078 surgical forceps designed to control bleeding. The devices' clamps break when used outside design parameters, potentially compromising their effectiveness.

    Product
    Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R,
    Category
    Medical Device
    Distribution
    Distributed nationwide