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.

801–825 of 1800

  • HighFDA (Devices)·Z-2320-2021·2021-08-25

    RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response

    Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.

    Product
    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2021·2021-08-18

    Covidien Sonicision Surgical Generator Recalled for Manufacturing Defect Risk

    Covidien recalls 96 units of its Sonicision Reusable Generator surgical device due to a manufacturing assembly error that may cause device malfunction, thermal burns, or tissue damage. The defect may also disable the audio indicator that signals device activation.

    Product
    Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2021·2021-08-18

    Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination

    Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.

    Product
    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Set recalled for potential internal leaks

    Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.

    Product
    Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2166-2021·2021-08-04

    Medical inflation device recalled due to handle separation risk

    Merit Medical Systems is recalling basixALPHA Inflation Devices due to a design flaw where the syringe handle can separate when withdrawn, affecting device functionality.

    Product
    basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2021·2021-07-21

    INGENIO DR EL Pacemakers Recalled: Defective Battery May Trigger Safety Mode

    Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.

    Product
    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2015-2021·2021-07-21

    Boston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction

    Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.

    Product
    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2072-2021·2021-07-21

    HeartWare HVAD Pump Implant Kit Impeller Defect Recall

    HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.

    Product
    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in pat
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1997-2021·2021-07-07

    Tempus Pro Patient Monitor Software Error Risk When Unplugged

    Remote Diagnostic Technologies is recalling Tempus Pro patient monitors (Trizeps 7 variant) that can produce error states when unplugged while connected to a specified laryngoscope device. No injuries have been reported.

    Product
    Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals lo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2021·2021-06-30

    AeroChamber PLS Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.

    Product
    AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2021·2021-06-30

    OptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.

    Product
    OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2021·2021-06-30

    FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure

    Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.

    Product
    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1935-2021·2021-06-30

    Vicks vaporizers recalled for temperature exposure during shipping

    Cardinal Health is recalling Vicks 1.5-gallon vaporizers exposed to temperature excursions during shipping delays in February-March 2021, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    VAPORIZER VICKS 1.5GAL Item Number: 2354942
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2021·2021-06-23

    Medtronic Perfusion Tubing Packs Recalled for Insufficient or Incomplete Welds

    Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.

    Product
    Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2021·2021-06-23

    VENOVO 9F Venous Stent System incomplete deployment and delivery system retention

    Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.

    Product
    VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VEN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2021·2021-06-23

    WorkMate Claris v.1.2 Upgrade Kits Software Error Causes Function Loss

    WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.

    Product
    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1797-2021·2021-06-16

    Medtronic Braive Growth Modulation System Break-Off Set Screws Recalled for Thread Defect

    Medtronic is recalling Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect caused by a manufacturing issue. The defect may affect proper device function.

    Product
    Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1827-2021·2021-06-16

    Anterior cervical plate system screw blocking mechanism defect recalled

    Alphatec Spine's Atec Insignia anterior cervical plate system has a defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure

    Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2021·2021-06-16

    Medical Device Illumination Pack Recalled Due to Burn and Occlusion Risks

    Nico Corp. is recalling 439 NICO Myriad-LX Illumination Packs used in surgical procedures due to potential delivery sleeve occlusion and thermal burn injury from the fiber tip assembly.

    Product
    NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1666-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling specific Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide