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.

126–150 of 152

  • ModerateFDA (Devices)·Z-1102-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 154 sterile bone fixation screws distributed nationwide due to insufficient sealer calibration data.

    Product
    Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW CRUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1167-2016·2016-03-23

    Zimmer Versys Cemented Femoral Stem Recall for Calibration Issues

    Zimmer Manufacturing B.V. is recalling 13 Versys Cemented Femoral Stems due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1145-2016·2016-03-23

    Zimmer Modular Hip Cups Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling sterile modular hip cups due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 6110050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1123-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Components for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific distal femoral components used in total hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1116-2016·2016-03-23

    Zimmer Manufacturing Recalls 83 Sterile Bone Fixation Screws

    Zimmer Manufacturing B.V. is recalling 83 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 47248001841 CANC SCR 4.0MM X 18MM FUL 47248002041 CANC SCR 4.0MM X 20MM FUL 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1134-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking IM Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 268 units of Interlocking IM Screws 4.5 due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5 2253040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1112-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling sterile intramedullary fixation rods and lag screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 225600237 ASIA ONE-PIECE LAG SCREW 225600240 ASIA ONE-PIECE LAG SCREW 225600242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2016·2016-02-17

    Moog Recalls Curlin Infusion Pumps Due to Calibration Defect

    Moog is recalling specific Curlin infusion pumps because calibration errors may cause them to deliver medication faster than programmed.

    Product
    Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2015·2015-02-11

    Radiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors

    Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.

    Product
    ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-0968-2015·2015-01-21

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using bot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0967-2015·2015-01-21

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0969-2015·2015-01-21

    Ortho VITROS 5600 System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because software may fail to identify expired calibrations.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2015·2014-11-05

    Siemens ADVIA Centaur Calibrator C Recalled for Ferritin Assay Sensitivity Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue affecting ferritin assay sensitivity.

    Product
    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0078-2015·2014-10-22

    Ortho VITROS 5600 Integrated System Recalled for Calibration Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may cause unexpected assay calibration when using specific calibrator kits.

    Product
    VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2014·2014-07-09

    Meridian Bioscience Recalls illumipro-10 Incubator/Reader Units for Calibration Issues

    Meridian Bioscience is recalling 35 illumipro-10 incubator/reader units because Block B chambers may operate at incorrect temperatures due to calibration errors.

    Product
    illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1085-2014·2014-03-12

    Elekta Agility software recall for potential calibration input errors

    Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could be entered during calibration procedures.

    Product
    Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2014·2014-03-12

    Elekta RT Desktop Software Recall for Calibration Input Errors

    Elekta is recalling RT Desktop software because users may enter incorrect values during calibration procedures for radiation therapy linear accelerators.

    Product
    RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a lic
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1076-2014·2014-03-05

    Siemens Dimension Vista Enzyme 1 Calibrator Recalled for QC Shifts

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Enzyme 1 Calibrator due to quality control shifts and imprecision during Pseudocholinesterase calibration.

    Product
    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0940-2014·2014-02-19

    Siemens ADVIA Chemistry Systems Recalled for Software Calibration Defect

    Siemens is recalling ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400 because specific software versions allow the systems to automatically run assay calibrations and quality control.

    Product
    Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2014·2013-10-23

    Siemens Recalls Dimension Vista Urinary Protein Reagent Cartridges

    Siemens is recalling Dimension Vista Urinary/Cerebrospinal Fluid Protein reagent cartridges due to confirmed absorbance errors during calibration.

    Product
    Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1663-2013·2013-07-10

    Siemens Linear Accelerator Recall Due to Potential Patient Mistreatment

    Siemens is recalling specific linear accelerator systems because a difficult-to-interpret calibration issue may have resulted in the mistreatment of cancer patients.

    Product
    Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2013·2013-06-19

    Embla Embletta Gold Recalled for Calibration Error Affecting Sleep Therapy

    Embla System LLC is recalling 519 Embletta Gold polysomnography recorders due to a calibration error that may lead to over-titration of sleep therapy.

    Product
    embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (exclud
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2012·2012-07-18

    Civco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 221 VirtuTRAX kits because the electromagnetic sensors were incorrectly calibrated, which may cause variability in projected needle paths.

    Product
    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the l
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1953-2012·2012-07-18

    Civco General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 30 kits of General Purpose Sensors due to incorrect calibration that may cause variability in needle path projection.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part numb
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1954-2012·2012-07-18

    CIVCO General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 100 CIVCO General Purpose Sensors because incorrect calibration may cause variability in the projected position of the needle path.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part nu
    Category
    Medical Device
    Distribution
    6 states