The Recall Desk

Hazard

Quality System Violation recalls

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

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2023-11-01

Of the 10 quality system violation 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 quality system violation 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.

1–10 of 10

  • HighFDA (Devices)·Z-0059-2024·2023-11-01

    SARS-CoV-2 Antibody Test Recalled Due to Manufacturing Compliance Issues

    Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.

    Product
    DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0064-2024·2023-11-01

    FDA Recalls Pregnancy Test Cassettes Due to Unverified Manufacturing

    Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.

    Product
    DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0060-2024·2023-11-01

    Diagnostic Test Strips Recalled for Manufacturing Conformance and Documentation Issues

    Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.

    Product
    DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0065-2024·2023-11-01

    Pregnancy Test Cassettes Recalled for Unknown Performance Characteristics

    Universal Meditech Inc. recalls DiagnosUS hCG Pregnancy Test cassettes distributed in eight U.S. states due to lack of manufacturing documentation and unknown performance characteristics. The firm is going out of business.

    Product
    DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2898-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2999-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Alignment Drivers

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MIS Alignment Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2877-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Crosslink Spinal Fixation Devices

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Small Crosslink devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Small Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3001-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Pusher for Quality System Issues

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Rod Pusher Angled because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2017·2017-06-14

    DePuy Synthes Orthopedic Instruments Recalled for Quality System Violations

    DePuy Orthopaedics is recalling 345 orthopedic instruments modified by U.S. distributors because they were made outside quality system regulations, potentially compromising safety and effectiveness.

    Product
    DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide