The Recall Desk

Hazard

System Error recalls

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

What the numbers show

Total
17
Critical
1
Severe
6
Most recent
2025-09-10

Of the 17 system error recalls we have scored against our rubric, 1 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (35%) 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 system 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.

1–17 of 17

  • CriticalFDA (Devices)·Z-2333-2025·2025-09-10

    Syringe pumps recalled over false motor movement system error messages

    Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.

    Product
    Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2338-2025·2025-08-27

    Electrosurgical generators recalled over system error causing reboots during use

    The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2025·2025-08-27

    Legacy electrosurgical generators recalled over system error triggering repeated device reboots

    The ESG-410 Legacy Electrosurgical Generator, model WA91307C, is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 434 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2025·2024-12-04

    V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures

    KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.

    Product
    V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2025·2024-11-06

    Olympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error

    Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.

    Product
    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1811-2024·2024-05-29

    Optum Nimbus II Plus Infusion Pump Recall Due to Potential Failure Modes

    OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.

    Product
    Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2024·2024-05-01

    Abbott Alinity m System camera generates error with certain tubes

    Abbott Molecular is recalling 1,012 Alinity m System units due to a camera detection issue that generates an error message when certain third-party transport medium tubes lack a sample rack retention bar.

    Product
    Alinity m System, Part Number: 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1286-2024·2024-04-03

    Nimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures

    InfuTronix is recalling 52,328 Nimbus II Infusion Pump Systems due to potential failure modes including battery failure, system errors, drug product leakage, flow rate issues, and housing damage. The devices will no longer be available or supported after June 20, 2024.

    Product
    Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1285-2024·2024-04-03

    Nimbus Ambulatory Infusion Pump recalled due to multiple failure modes

    InfuTronix is recalling Nimbus Infusion Pump Systems (Nimbus Flex, Nimbus PainPro) due to potential battery failure, system errors, drug leakage, flow rate abnormalities, and housing damage. About 52,328 units are affected nationwide.

    Product
    Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci SP Systems Due to Defective Capacitors

    Intuitive Surgical is recalling four da Vinci SP Surgical Systems because defective capacitors on circuit boards may cause vision loss or non-recoverable system errors.

    Product
    da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0049-2017·2016-10-12

    Toshiba Celesteion CT Scanner Recalled for Potential Reconstruction Errors

    Toshiba is recalling 165 Celesteion CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0046-2017·2016-10-12

    Toshiba Aquilion Lightning CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion Lightning CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum Field of View.

    Product
    Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0019-2016·2015-10-14

    Siemens SOMATOM Definition Edge CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition Edge CT scanners due to a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2015·2015-03-25

    Baxter HomeChoice Pro APD System Recalled for Occluder Defect

    Baxter Healthcare is recalling 75 HomeChoice Pro APD systems because the occluder may have sharp edges or separate, causing system errors or therapy termination.

    Product
    The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1484-2014·2014-04-30

    Baxter Recalls Sigma Spectrum Volumetric Infusion Pumps Due to System Errors

    Baxter Healthcare is recalling Sigma Spectrum Volumetric Infusion Pumps due to repeated System Error 322 occurrences.

    Product
    SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0534-2014·2014-01-01

    CareFusion Recalls Alaris PC Units Due to System Error Messages

    CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.

    Product
    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1047-2013·2013-04-10

    Siemens Dimension EXL LM STM Recalled for System Check Failures

    Siemens is recalling 2,207 Dimension EXL LM STM analyzers worldwide due to System Check failures that cause inconvenience but do not affect test results.

    Product
    Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states