The Recall Desk

Hazard

Misalignment recalls

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

What the numbers show

Total
58
Critical
0
Severe
0
Most recent
2025-12-24

Of the 58 misalignment recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 misalignment 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.

26–50 of 58

  • HighFDA (Devices)·Z-1384-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1368-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1388-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1371-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1366-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1377-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2019·2019-07-24

    GE Healthcare Recalls Two Ultrasound Systems Due to Transducer Misalignment

    GE Healthcare is recalling two ultrasound systems because transvaginal probes may be misaligned. The devices were distributed in the US and internationally.

    Product
    Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0938-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 37 Proteus 235 Proton Therapy Systems due to a risk of patient misalignment when using treatment plans with multiple isocenters.

    Product
    Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0352-2018·2018-01-24

    Medtronic KYPHON Express Directional Bone Filler Device Recall

    Medtronic is recalling KYPHON Express Directional Bone Filler Devices because the directional arrow may not align with the opening.

    Product
    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0351-2018·2018-01-24

    Hologic Recalls Affirm Lateral Arm Upright Biopsy Accessory Due to Component Issue

    Hologic, Inc. is correcting 12 Affirm Lateral Arm Upright Biopsy Accessories in the U.S. due to a component issue that could impact needle alignment during lateral biopsy procedures.

    Product
    Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2247-2017·2017-06-14

    Medtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect

    Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.

    Product
    KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0411-2017·2016-11-23

    Mevion S250 Proton Radiation Therapy System Software Defect Recall

    Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to a software defect that causes 2D contour projections to appear off from their true position.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2534-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing is recalling 70 Bone Level Implants because misalignment with the Loxim transfer piece may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1264-2016·2016-04-06

    Wfr/aquaplast Recalls Prone Breast Treatment Tables Due to Scale Misalignment

    Wfr/aquaplast Corp is recalling 30 prone breast treatment tables and devices because some may have misaligned scales, potentially causing orientation differences.

    Product
    Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient suppo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2016·2015-11-04

    Materialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies

    Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.

    Product
    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0495-2015·2014-12-10

    Zimmer PSI Knee System Recalled for Potential Misalignment Design Flaw

    Zimmer CAS is recalling 15 PSI Knee System units due to a design flaw that could lead to misalignment during surgery.

    Product
    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2118-2014·2014-08-06

    Medtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment

    Medtronic is recalling Nexdrive Micropositioning Drives because a scale misalignment could cause microelectrodes to be inserted at incorrect depths during surgery.

    Product
    Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtro
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1961-2014·2014-07-09

    Integra Recalls NewPort MIS Rod 2 Due to Potential Misalignment

    Integra LifeSciences is recalling 94 units of NewPort MIS Rod 2 because the rods may be offset from specifications, potentially causing misalignment during surgical insertion.

    Product
    MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1045-2014·2014-02-26

    Biosense Webster Recalls CartoUnivu Module for Map Misalignment

    Biosense Webster is recalling the CartoUnivu Module for the Carto 3 System due to potential misalignment between the map display and fluoroscopic images.

    Product
    CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLU
    Category
    Medical Device
    Distribution
    5 states