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.

326–350 of 881

  • HighFDA (Devices)·Z-2761-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2723-2020·2020-08-12

    CareFusion Alaris Auto ID Module Recall Due to Cleaning Agent Damage

    CareFusion is recalling Alaris Auto ID Modules because cleaning agents may damage connectors, causing infusion interruptions and therapy stops.

    Product
    Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2763-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2759-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2726-2020·2020-08-05

    Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage

    Teleflex Medical Inc. is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall affects 75,320 units distributed nationwide.

    Product
    Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2020·2020-07-29

    Boston Scientific Recalls IcePearl 2.1 CX Prostate Kit Due to Needle Deterioration

    Boston Scientific is recalling 193 IcePearl 2.1 CX Prostate Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2020·2020-07-22

    Medtronic Bone Void Filler Recalled for Potential Failure to Set

    Skeletal Kinetics is recalling Medtronic Bone Void Filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2413-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component vibration issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2408-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2409-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2417-2020·2020-07-08

    Arrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2392-2020·2020-06-24

    Defibtech DDU-2300 AED Recalled for Potential Shock Delivery Failure

    Defibtech is recalling 860 DDU-2300 AEDs because a component issue may cause the device to abort or fail to deliver a shock.

    Product
    DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2273-2020·2020-06-17

    Genicon Natura Cannula Recall Due to Detachable Optical Tip

    Genicon, Inc. is recalling Natura Model 210-005-051 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2229-2020·2020-06-10

    FDA Recalls Zimmer Biomet Vital MIS Spinal Fixation Implants

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2020·2020-06-03

    Philips Recalls Sterilizable Defibrillator Internal Paddles Due to Wear Risk

    Philips is recalling 21,683 sets of sterilizable defibrillator internal paddles because they may wear over time and fail to deliver therapy if routine checks are not performed.

    Product
    Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2057-2020·2020-06-03

    Heartware HVAD Pump Implant Kit Recalled for Graft and Screw Defects

    Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.

    Product
    Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2053-2020·2020-05-27

    Philips HeartStart XL Defibrillator Recalled for Rotary Switch Failure

    Philips is recalling HeartStart XL Defibrillators because a faulty switch may prevent the device from turning on or delivering the correct shock energy.

    Product
    Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: 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, advanced cardiac life support, or defibrillation. I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2031-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage

    K2M, Inc. is recalling Aleutian Interbody Spacer Systems because the welded spreader tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2020·2020-05-27

    Applied Medical Stealth Spring Clip Recall for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 units of Stealth Spring Clips due to a risk of insufficient vessel occlusion during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2034-2020·2020-05-27

    Applied Medical Stealth Spring Clip Recall for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2020·2020-05-20

    Cardiac Assist Recalls TandemHeart ProtekDuo Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 46 TandemHeart ProtekDuo Kits due to an assembly error that may cause failure to prime.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2020·2020-05-20

    Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error

    Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide