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.

1–25 of 58

  • HighFDA (Devices)·Z-1636-2024·2024-05-01

    Quidel InflammaDry MMP-9 Test: Misaligned Results Window May Cause False Negatives

    Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.

    Product
    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1637-2024·2024-05-01

    Medical diagnostic test kits recalled due to misaligned results window

    Quidel InflammaDry MMP-9 test kits are recalled because the test results window is misaligned. Positive results may be hidden from view, potentially causing false negative readings.

    Product
    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0755-2024·2024-01-24

    Suction Canister Liners Recalled for Potential Loss of Suction Function

    Cardinal Health suction canister liners may lose suction on low settings due to liner misalignment. Approximately 203,244 units distributed to the US, Canada, Australia, and New Zealand.

    Product
    Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0754-2024·2024-01-24

    Suction Canister Liner Recalled for Loss of Suction on Low Settings

    Cardinal Health Suction Canister Liners may lose suction on low or intermittent settings due to liner misalignment. Approximately 3.5 million units are affected across the US, Canada, Australia, and New Zealand.

    Product
    CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2400-2021·2021-09-08

    TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments

    DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1793-2021·2021-06-09

    Zimmer Femoral Nail Recall: Risk of Commingled Angle Versions

    Zimmer is recalling 16 units of its Natural Nail femoral implant due to potential commingling between two versions with different CCD angles (130 and 125 degrees). Wrong angle components could result in improper fracture fixation.

    Product
    Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1498-2021·2021-05-05

    ConMed Infinity Tray Custom Procedural Kit Recalled for Misaligned Guides

    ConMed Corporation is recalling two Infinity Tray Custom Procedural Kits in Canada and Italy because the tip guides may be misaligned, potentially affecting surgical accuracy.

    Product
    INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product w
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1175-2021·2021-03-17

    Canon Medical System INFX-8000C C-Arm Recall for X-Ray Field Shift

    Canon Medical System is recalling 272 INFX-8000C C-arm systems nationwide because the x-ray irradiation field may shift relative to the displayed image at certain angles.

    Product
    System INFX-8000C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0651-2021·2020-12-30

    ConMed Recalls Infinity ACL Tibial Tip Guides Due to Misalignment

    ConMed Corporation is recalling 95 Infinity ACL Tibial Tip Guides because the tips may be laterally misaligned, potentially affecting the accuracy of the guide system.

    Product
    Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2021·2020-12-30

    ConMed Infinity ACL Tibial Elbow Guide Recalled for Misalignment

    ConMed Corporation is recalling 73 units of the Infinity ACL Tibial Elbow Guide because the tips may be misaligned, potentially affecting the accuracy of the guide system.

    Product
    Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0073-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments

    Biomet 3i, LLC is recalling BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0079-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0077-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 35 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0075-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Dental Abutments

    Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0074-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0078-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 10 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1370-2020·2020-03-04

    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 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
    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
  • HighFDA (Devices)·Z-1372-2020·2020-03-04

    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 dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1373-2020·2020-03-04

    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 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
    Category
    Medical Device
    Distribution
    Distributed nationwide