The Recall Desk

Hazard

Drug Overdose 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
2
Severe
3
Most recent
2026-07-22

Of the 6 drug overdose recalls we have scored against our rubric, 2 (33%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (50%) 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 drug overdose 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

  • SevereFDA (Devices)·Z-2723-2026·2026-07-22

    ICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery

    ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.

    Product
    ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2740-2017·2017-07-26

    Flowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI

    Flowonix Medical is recalling Prometra II implantable infusion pumps after a report of a fatal drug overdose during an MRI procedure.

    Product
    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2014·2014-05-14

    Medtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk

    Medtronic is recalling SynchroMed II implantable drug infusion pumps because they may overinfuse medication, potentially causing life-threatening overdose or drug withdrawal.

    Product
    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1570-2013·2013-07-03

    Medtronic SynchroMed II Pump Recall for Unintended Drug Delivery

    Medtronic is recalling SynchroMed II implantable infusion pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose symptoms.

    Product
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2013·2013-07-03

    Medtronic SynchroMed EL Pumps Recalled for Unintended Drug Delivery

    Medtronic is recalling SynchroMed EL implantable pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose.

    Product
    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1787-2012·2012-06-27

    GE Healthcare Recalls Aestiva 7900 Anesthesia Machines Due to Missing Interlock

    GE Healthcare is recalling eight Aestiva 7900 anesthesia machines because a missing interlock slide may allow two vaporizers to deliver agents simultaneously.

    Product
    GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide