The Recall Desk

Hazard

Device Failure Risk recalls

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2024-12-04

Of the 6 device failure risk recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 risk 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.

1–6 of 6

  • HighFDA (Devices)·Z-0504-2025·2024-12-04

    Defibtech Adult Defibrillation Pads Recalled for Labeling Error Risk

    Defibtech is recalling 22,294 DDP-2001 Adult Defibrillation Pads distributed in Ireland. Some pads had unauthorized labels applied, which could allow expired pads to appear current, and dried hydrogel may reduce electrical delivery during use.

    Product
    Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2362-2024·2024-07-24

    Abbott Proclaim 5 Pulse Generator May Have Shorter Than Labeled Battery Duration

    Abbott Proclaim 5 Implantable Pulse Generators may have a shorter battery lifespan than labeled, potentially affecting replacement timing for patients.

    Product
    Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2024·2024-06-12

    Vascular graft recalled due to slider component separation risk

    Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that could compromise device function.

    Product
    ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2023·2022-10-19

    Hobbs Biliary Pigtail Stent Kits recalled due to incorrect expiration dates

    Hobbs Medical is recalling certain Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual validity. Affected devices distributed between March 2018 and September 2020 may be used beyond their true expiration date.

    Product
    Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2021·2021-07-28

    Drain Bag Set for Peritoneal Dialysis Exposed to Freezing During Transport

    A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.

    Product
    The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects t
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1877-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.

    Product
    Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide