The Recall Desk

Hazard

Over Infusion recalls

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

What the numbers show

Total
56
Critical
5
Severe
36
Most recent
2026-01-28

Of the 56 over infusion recalls we have scored against our rubric, 5 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 36 (64%) 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 over infusion 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.

51–56 of 56

  • SevereFDA (Devices)·Z-1248-2019·2019-05-08

    Baxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors

    Baxter Healthcare is recalling 158 SIGMA Spectrum Infusion Pumps because flow rate tests were performed for less than the required time, potentially leading to inaccurate fluid administration.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2013·2013-08-14

    Iradimed MRidium Dose Reduction System Recall for Infusion Rate Errors

    Iradimed is recalling MRidium 1145 Dose Reduction System kits because they may display incorrect infusion rates, posing a risk of over- or under-infusion.

    Product
    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1117-2013·2013-04-24

    Hospira GemStar Infusion Pump Recall for Potential Over-Infusion

    Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, causing the device to deliver too much medication.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1116-2013·2013-04-24

    Hospira GemStar Infusion Pump Recall for Potential Over-Infusion Risk

    Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2013·2013-03-20

    Symbios GOPump Elastometric Infusion PumpKit Recalled for Flow Restrictor Displacement

    Symbios Medical Products is recalling 458 GOPump Elastometric Infusion PumpKits because a flow restrictor bead may become displaced, permitting fast flow of contents.

    Product
    GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1490-2012·2012-06-20

    Baxter Sigma Spectrum Infusion Pump Recall for Bearing Failure Risk

    Baxter Healthcare is recalling 63,225 Sigma Spectrum Infusion Pumps because bearing lubricant loss can cause flow failures and potential over-infusion.

    Product
    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the cont
    Category
    Medical Device
    Distribution
    Distributed nationwide