The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) are Severe.

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.

776–800 of 881

  • CriticalFDA (Devices)·Z-1454-2014·2014-04-23

    FDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk

    Micro Therapeutics Inc is recalling Alligator Retrieval Devices because the PTFE coating may delaminate and detach from the delivery wire.

    Product
    Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2014·2014-04-02

    Teleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect

    Teleflex Medical is recalling 32,271 units of non-absorbable steel sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-mol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2014·2014-03-26

    Teleflex Recalls Rusch Endobronchial Tubes Due to Cuff Seal Failure

    Teleflex Medical is recalling Rusch Brochopart endobronchial tubes because the cuff may inflate to one side, preventing a proper seal of the right lung.

    Product
    Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1109-2014·2014-03-05

    Philips HeartStart XL Defibrillators Recalled for Power Board Failure

    Philips is recalling 5,234 HeartStart XL Defibrillators/Monitors because a power board failure may prevent the device from defibrillating.

    Product
    Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wear Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because therapy connections may wear prematurely, posing a risk to patients and caregivers.

    Product
    Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ECG Cable Wear

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the ECG trunk cable and connector block may wear prematurely, causing an interrupted ECG signal.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0999-2014·2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2014·2014-02-26

    Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.

    Product
    Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2014·2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2014·2014-02-19

    Integra Recalls Malibu Polyaxial Screwdrivers Due to Potential Shaft Breakage

    Integra LifeSciences is recalling 40 Malibu Polyaxial Screwdrivers because the shaft may break during use. No patient injuries have been reported.

    Product
    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical impl
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0859-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0860-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 746 Codman Certas Programmable Valves because they may not operate properly. The devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and dra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,481 Codman Certas Programmable Valves because they may not operate properly, potentially affecting hydrocephalus management.

    Product
    Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2014·2014-01-29

    Sorin Orchestra Programmer Overestimates Pacemaker Battery Life

    Sorin Group Italia is notifying physicians that its Orchestra programmer may overestimate the residual longevity of specific implanted pacemakers.

    Product
    ORCHESTRA/ORCHESTRA PLUS Programmer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2014·2014-01-29

    Medrad Recalls Veris MR Monitor Units Due to Faulty Main Board

    Medrad is recalling 922 Veris MR Monitor units because a faulty main board may cause unexpected system shutdowns, resulting in the loss of vital signs information.

    Product
    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2014·2014-01-15

    Welch Allyn Propaq LT Series Monitors Recalled for Potential Operational Interruption

    Welch Allyn is updating software on Propaq LT Series monitors because rare hardware or software faults could interrupt device operations.

    Product
    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2014·2014-01-15

    Integra Small Rickham-Style Reservoirs Recalled for Bent or Broken Connectors

    Integra LifeSciences is recalling 194 packages of Small Rickham-Style Reservoirs due to bent or broken connectors found after opening the sterile package.

    Product
    Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining C
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0623-2014·2014-01-15

    Aesculap Recalls Hi-Line XXS Handpieces Due to Possible Failure

    Aesculap, Inc. is recalling 14 Hi-Line XXS handpieces due to a possible failure of the device. The handpieces are used to hold burrs that cut and shape bone.

    Product
    Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0597-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling 352 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0596-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnection

    Asante Solutions is recalling 635 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage

    Asante Solutions is recalling Conset Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and delivering less insulin than intended.

    Product
    Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2014·2014-01-08

    Philips HeartStart MRx Defibrillators Recalled for Potential Shutdown

    Philips is recalling HeartStart MRx monitor/defibrillators because they may shut down without warning if exposed to elevated electromagnetic interference.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0458-2014·2013-12-18

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Recalled

    Ethicon is recalling Stratafix Symmetric PDS Plus Knotless Tissue Control Devices due to reported tab failures and fascial dehiscences in lower abdominal incisions.

    Product
    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14044·2013-12-09

    Linear Recalls PERS Transmitters Due to Battery Signal Failure

    Linear is recalling about 48,000 Personal Emergency Reporting System transmitters because battery clips can corrode, causing the devices to fail without warning.

    Product
    Personal Emergency Reporting System (PERS) Transmitters
    Category
    Consumer Product
    Distribution
    Distributed nationwide