The Recall Desk

Hazard

Delayed Therapy recalls

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

What the numbers show

Total
24
Critical
9
Severe
3
Most recent
2026-08-26

Of the 24 delayed therapy recalls we have scored against our rubric, 9 (38%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (13%) 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 delayed therapy 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.

1–24 of 24

  • HighFDA (Devices)·Z-2872-2026·2026-08-26

    BD Needle Kit for Powered Driver Recall Due to Removal Difficulty

    Bard Access Systems is recalling BD Needle Kits for Powered Drivers because the obturator may lock to the hub, potentially delaying emergency therapy.

    Product
    BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Dr
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0958-2026·2025-12-24

    Insulin pen app recalled over notifications lost after reinstalling the app

    Medtronic MiniMed is recalling 8,251 units of the InPen App for Android because reinstalling the app deletes the notification override permission, so audible and vibratory alerts are not received.

    Product
    InPen App, Model/CFN Number: MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0906-2025·2025-01-22

    BD Pyxis MedStation ES software issue may delay medication dispensing

    A software bug in BD Pyxis MedStation ES medication dispensing cabinets may prevent staff from locating alternate supply locations, potentially delaying patient therapy.

    Product
    BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2024·2024-05-22

    HeartSine Public Access Defibrillators Recalled for Voice Prompt Manufacturing Defect

    Certain HeartSine PAD defibrillators may fail to deliver voice prompts during emergency use due to a manufacturing defect, potentially delaying therapy. Visual instructions remain available.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2024·2024-02-21

    HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw

    HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2021·2020-12-23

    FDA Recalls Tempus LS Manual Defibrillators Due to Software Error

    Remote Diagnostic Technologies is recalling 175 Tempus LS manual defibrillators because a software error may delay therapy by disrupting ECG calibration.

    Product
    Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2684-2020·2020-07-29

    Nuvasive NVM5 EMG Module Recalled for Incorrect Component

    NuVasive Inc is recalling 23 NVM5 EMG Modules because they contain an incorrect SSEP harness instead of the correct NVM5 Harness, potentially delaying spinal surgery monitoring.

    Product
    Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1154-2020·2020-02-19

    Respironics Ventilator Touchscreen Recall Due to Unresponsive Controls

    Respironics is recalling V60/V680 ventilator touchscreens that may freeze and fail to respond to touch commands, potentially delaying necessary therapy adjustments.

    Product
    Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2018·2018-06-06

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure

    Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.

    Product
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0306-2017·2016-11-02

    Hospira Symbiq Infuser Recall for Potential White Screen Error

    Hospira is recalling Symbiq Two Channel Infusers because a white screen error during KVO titration could delay therapy and cause significant injury.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0963-2015·2015-01-21

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because the device may malfunction, potentially delaying or disabling therapy or delivering it inadvertently.

    Product
    HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0456-2015·2014-12-10

    ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes

    ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0461-2015·2014-12-10

    ConMed Pediatric Multifunction Electrodes Recalled for Connection Design Flaws

    ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to patient death or serious injury.

    Product
    CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0458-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Failure Risk

    ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0459-2015·2014-12-10

    ConMed Pediatric Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling 174,610 pediatric radiotransparent electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0460-2015·2014-12-10

    ConMed Pediatric Electrodes Recalled Due to Connection Design Changes

    ConMed is recalling 174,610 pediatric electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking death or serious injury.

    Product
    MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0455-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0457-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0462-2015·2014-12-10

    ConMed Multifunction Electrodes Recalled for Connection Design Failure

    ConMed is recalling multifunction electrodes due to a design change that may prevent connection to Philips AEDs, potentially delaying therapy.

    Product
    CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0454-2015·2014-12-10

    ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Failure

    ConMed is recalling Adult Radiotransparent Electrodes because a design change in Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2014·2014-07-30

    Heartsine AED Electrode Pouches Recalled for Difficulty Opening

    Heartsine is recalling Pad-Pak and Pedi-Pak electrode accessories for the Samaritan PAD 300P and 350P because some sealed foil pouches are difficult to open, potentially delaying therapy.

    Product
    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recall for Software Communication Failure

    Philips is recalling HeartStart XL+ Defibrillators because a software failure may lock users out of clinical mode, potentially delaying therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide