The Recall Desk

Hazard

Incorrect Dosing recalls

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

What the numbers show

Total
26
Critical
0
Severe
6
Most recent
2023-03-22

Of the 26 incorrect dosing recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (23%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all incorrect dosing 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.

1–25 of 26

  • HighFDA (Devices)·Z-1258-2023·2023-03-22

    Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision

    Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.

    Product
    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2022·2022-05-18

    Phototherapy Units Recalled for Software Bug Causing Incorrect Dosing

    Daavlin's 4 Series CX phototherapy units are recalled due to a software defect that can cause incorrect dosing (over or under) when resuming interrupted treatments.

    Product
    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2315-2021·2021-08-25

    CT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting

    Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.

    Product
    Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2021·2021-03-17

    Insulet Recalls Omnipod DASH User Guides Due to Decimal Error

    Insulet Corporation is recalling 21,723 Omnipod DASH User Guides distributed outside the US due to a misprint regarding decimal separators that could lead to incorrect bolus delivery.

    Product
    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0804-2021·2021-01-13

    Roche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS PST meters because they may display blood-clotting results in the wrong units. Users should verify their meter is set to INR.

    Product
    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet is recalling 400 Omnipod DASH insulin systems because the Bolus Calculator may fail to subtract insulin on board correctly after two months of use.

    Product
    Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2091-2019·2019-08-07

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.

    Product
    Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1327-2019·2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Error

    PENTAX of America Inc is recalling 4 C2 CryoBalloon Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1325-2019·2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors

    Pentax of America Inc is recalling 157 C2 CryoBalloon Standard Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysp
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-1899-2017·2017-05-10

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Error

    Roche Diabetes Care is recalling specific versions of the Accu-Chek Connect app because a bug in the Bolus Advisor feature may provide incorrect insulin dosing advice.

    Product
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1099-2017·2017-02-01

    Roche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors

    Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1026-2017·2017-01-25

    Fresenius 2008T Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008T Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008T Series Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2017·2016-11-23

    Roche Recalls Accu-Chek Connect iOS App Version 1.2.0 Due to Software Bug

    Roche Diabetes Care is recalling version 1.2.0 of the Accu-Chek Connect iOS app because a programming error in the Bolus Advisor feature could lead to incorrect insulin bolus recommendations.

    Product
    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2790-2016·2016-09-21

    Hospira MedNet Software Recall for Incorrect Bolus Calculations

    Hospira is recalling MedNet 6.1 software used with SapphirePlus infusion pumps because it may calculate incorrect bolus amounts for drugs in Million Units.

    Product
    Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible co
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0586-2016·2016-02-03

    Perrigo Recalls Guaifenesin Liquid Due to Incorrect Dosing Cup Markings

    Perrigo Company PLC is recalling specific lots of Guaifenesin liquid because the included dosing cups have incorrect dose markings.

    Product
    Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for:
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2015·2015-08-05

    Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.

    Product
    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2015·2014-11-05

    Roche Recalls ACCU-CHEK Spirit Combo Insulin Pumps Due to Time Settings

    Roche is recalling 8,116 ACCU-CHEK Spirit Combo insulin pumps because a faulty capacitor may cause time and date settings to reset, potentially shifting insulin delivery schedules.

    Product
    ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2014·2014-09-03

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Programming Error

    Medtronic is recalling MiniMed Paradigm insulin pumps because users may have accidentally programmed them to deliver the maximum bolus amount.

    Product
    Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1448-2014·2014-07-30

    Shamrock Recalls Metformin ER Tablets Labeled as Immediate Release

    Shamrock Medical Solutions is recalling metformin ER tablets that were incorrectly labeled as immediate release. The mislabeling could lead to incorrect dosing.

    Product
    metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-1869-2014·2014-07-02

    Elekta MOSAIQ Oncology System Recalled for Dose Calculation Error

    Elekta, Inc. is recalling MOSAIQ oncology information system software because it fails to recalculate agent volume when users change the ordering dose.

    Product
    MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2014·2014-05-21

    Baxter ABACUS TPN Calculation Software Recalled for Calculation Errors

    Baxter Corporation is recalling ABACUS TPN Calculation Software because it may calculate incorrect electrolyte quantities and display inaccurate data.

    Product
    ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0827-2014·2014-02-19

    Tandem T:slim Insulin Pump Cartridges Recalled for Leak Risk

    Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.

    Product
    T:slim Insulin Delivery System Insulin Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2014·2013-12-04

    Roche Recalls ACCU-CHEK Aviva Combo Blood Glucose Meters

    Roche is recalling 6,595 ACCU-CHEK Aviva Combo Blood Glucose Meters due to a software issue that may cause incorrect insulin bolus advice.

    Product
    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2013·2013-09-18

    B. Braun Outlook ES Pumps Recalled for Potential Drug Library Loss

    B. Braun Medical is recalling Outlook ES pumps because a software issue could cause the drug library to be lost, potentially leading to incorrect medication dosing.

    Product
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2012·2012-08-15

    Baxter Recalls Automix 3+3 Compounders Due to Electrical Failures

    Baxter Healthcare is recalling 950 Automix 3+3 Compounders because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

    Product
    AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nut
    Category
    Medical Device
    Distribution
    Distributed nationwide