Hazard

Infusion Error recalls

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

What the numbers show

Total: 10
Critical: 0
Severe: 1
Most recent: 2025-02-12

Of the 10 infusion error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (10%) 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 infusion error 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.

1–10 of 10

SevereFDA (Devices)·Z-1019-2025·2025-02-12
Ivenix Infusion System software recalled for pump malfunction risk
The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1544-2021·2021-05-19
Infusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts
Infusion Pump Repair is recalling 15 Alaris Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, causing infusion errors.
Product
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1543-2021·2021-05-19
Step-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts
Step-Har Medical is recalling two Alaris Pump Modules serviced with non-original bezel repair parts that may crack or separate, potentially causing infusion errors.
Product
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1375-2021·2021-04-28
Aftermarket Alaris Infusion Pump Front Bezel Recall for Potential Infusion Errors
Pacific Medical Group is recalling 2,452 aftermarket Alaris infusion pump front bezels installed between July 2020 and February 2021. The bezel posts may crack or separate, potentially causing infusion errors.
Product
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2021·2021-04-14
Tenacore Recalls Alaris Infusion Pump Modules with Impacted Bezel Repair Parts
Tenacore LLC is recalling 474 Alaris Infusion Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, potentially causing infusion errors.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1332-2021·2021-04-14
Tenacore Alaris Infusion Pump Bezel Recall for Cracking Risk
Tenacore LLC is recalling Alaris Infusion Pump 8100 bezels because they may crack or separate, potentially causing infusion errors.
Product
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-2882-2020·2020-09-16
CareFusion Recalls BD Alaris Modules for Incorrect Syringe Display
CareFusion 303, Inc. is recalling BD Alaris Syringe and PCA Modules because they may display incorrect syringe types or sizes, potentially causing infusion errors.
Product
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-0971-2018·2018-03-21
Baxter SIGMA Spectrum Infusion Pump Recall for Pumping Mechanism Wear
Baxter is recalling SIGMA Spectrum Infusion Pumps because excessive wear in the pumping mechanism may cause over- or under-infusion of fluids.
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Category
Medical Device
Distribution
2 states
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
HighFDA (Devices)·Z-0996-2013·2013-04-03
Smiths Medical Medfusion Syringe Pumps Recalled for Seal Migration Risk
Smiths Medical is recalling six Medfusion Model 3500 syringe pumps in New Hampshire because a seal defect could cause the plunger rod seal to migrate during specific infusion conditions.
Product
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Category
Medical Device
Distribution
1 state