The Recall Desk

Hazard

Calibration Error recalls

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

What the numbers show

Total
152
Critical
0
Severe
8
Most recent
2026-07-22

Of the 152 calibration 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 8 (5%) 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 calibration 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.

1–25 of 152

  • ModerateFDA (Devices)·Z-2742-2026·2026-07-22

    Photera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration

    Daavlin Distributing Company is recalling the Photera 400 phototherapy device because the UV sensor calibration is calculating incorrectly, resulting in lower output levels than intended.

    Product
    Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2743-2026·2026-07-22

    Photera 600 Phototherapy Device UV Sensor Calibration Error

    Daavlin Distributing Company is recalling 26 Photera 600 phototherapy devices nationwide because the UV sensor gain calibration is incorrect, causing inaccurate ultraviolet output readings.

    Product
    Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2744-2026·2026-07-22

    Photera 600 3-D phototherapy device UV sensor calibration error recall

    Daavlin Distributing Company is recalling Photera 600 3-D phototherapy devices because the UV sensor gain calculation is incorrect, causing inaccurate ultraviolet output measurement.

    Product
    Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2026·2026-06-10

    Phothera 200 phototherapy calibration certificates had outputs reversed

    Phothera 200 phototherapy devices are being recalled because some Calibration and Output Certificates had the outputs reversed. 368 units are affected.

    Product
    Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2026·2026-03-11

    Roche cobas analyzer may repeat previous results for spline calibrated assays

    Roche is recalling cobas pro sample supply units on software versions before 03-02 because a defect can make the analyzer repeat the last calculated result for all later measurements.

    Product
    cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1404-2026·2026-02-25

    Medline Burn Care Kits Recalled Over Sterilization Calibration Issues

    Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2026·2026-02-25

    Medline Labor and Delivery Convenience Kits Recalled Over Sterilization Calibration

    Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1415-2026·2026-02-25

    Medline Recalls Surgical Convenience Kits Over Sterilization Calibration Issues

    Medline is recalling 12,418 units of various surgical convenience kits due to calibration issues with equipment used for sterilization and packaging, which may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1387-2026·2026-02-25

    Medline Nerve Block Trays Recalled Over Sterilization Calibration Issues

    Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1385-2026·2026-02-25

    Medline Tracheostomy Convenience Kits Recalled Over Sterilization Calibration Concerns

    Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1397-2026·2026-02-25

    Medline Sterile Surgical Kits Recalled Over Sterilization Equipment Calibration

    Medline is recalling 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2026·2026-02-25

    Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues

    Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2026·2026-02-25

    Medline C-Section Surgical Kits Recalled Over Sterilization Calibration

    Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.

    Product
    Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2026·2025-10-08

    Washer disinfectors recalled over overheating risk from incorrect pressure calibration

    Getinge is recalling 902 88-Series washer-disinfectors that can overheat during operation if the circulation pressure calibration was not performed, or was performed incorrectly.

    Product
    Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2025·2025-07-09

    BD FACS 7-Color Setup Beads Recalled Due to Spectral Overlap Errors

    Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.

    Product
    REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1996-2025·2025-07-02

    DxI 9000 Access Immunoassay Analyzer calibration system error recall

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous test results.

    Product
    DxI 9000 Access Immunoassay Analyzer C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1815-2025·2025-06-04

    Apo B Reagent calibration error may produce inaccurate test results

    Beckman Coulter is recalling Apo B Reagent due to an erroneous value in the calibration sheet that could generate incorrect patient test results with positive bias up to 42%.

    Product
    Apo B Reagent, REF: OSR6143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1190-2025·2025-02-26

    RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning

    RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2025·2024-11-13

    Beckman Coulter Access Cortisol Assay Recalled for Calibration Error

    Beckman Coulter is recalling 149 units of the Access Cortisol assay due to an incorrect calibration curve parameter that may cause test delays and potential injuries.

    Product
    The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0279-2025·2024-11-06

    Blood Oximeter Calibration Error Causes Inaccurate Oxygen Readings

    The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.

    Product
    AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0102-2025·2024-10-23

    Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error

    Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2025·2024-10-16

    Medical Analyzer Software Flaw Allows Use of Expired Calibrator

    Beckman Coulter DxI 9000 immunoassay analyzers with software version 1.16.2 and prior can process orders using expired calibration material, potentially producing incorrect patient laboratory test results.

    Product
    Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0044-2025·2024-10-16

    MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error

    Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.

    Product
    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3187-2024·2024-10-02

    Roche Creatine Kinase test reagents recalled for calibration errors

    Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.

    Product
    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3122-2024·2024-09-18

    FilmArray 2.0 Diagnostic Instruments Recalled for Calibration Error Affecting Test Results

    BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.

    Product
    FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
    Category
    Medical Device
    Distribution
    Distributed nationwide