The Recall Desk

Hazard

Quality System Non Compliance recalls

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

What the numbers show

Total
178
Critical
0
Severe
0
Most recent
2023-11-01

Of the 178 quality system non compliance 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 non compliance 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 178

  • HighFDA (Devices)·Z-0052-2024·2023-11-01

    Diagnostic test products recalled by Universal Meditech for missing FDA clearance

    Universal Meditech Inc. is recalling multiple diagnostic test products distributed without FDA authorization or documented quality system compliance. The company is unable to provide manufacturing or post-market surveillance documentation.

    Product
    PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0061-2024·2023-11-01

    Unauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech

    Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.

    Product
    Lem Fertility hCG Pregnancy Urine Test REF 100-12
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0063-2024·2023-11-01

    Pregnancy test strips recalled for lack of FDA authorization and quality documentation

    Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.

    Product
    DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2897-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Set Screws for Quality System Non-Compliance

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

    Product
    PALLAS M/MAXIMIS Set Screw. 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-2910-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Polyaxial Spinal Screws

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS polyaxial screws due to quality system non-compliance. The devices are intended for spinal fixation.

    Product
    PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 x 40mm. 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2932-2017·2017-08-16

    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 40mm. 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-2933-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues

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

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. 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-2959-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 400mm Straight Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 400mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 400mm Straight Rod. 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-2940-2017·2017-08-16

    Valorem Surgical Recalls Pallas M 35mm Curved Rods for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M 35mm Curved Rods because they do not meet FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 35mm Curved Rod. 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-2930-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

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

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2989-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Extension Guide Bushes for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Guide Bushes because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Extension Guide Bush. 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-2947-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 35mm Straight Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 35mm Straight Rod. 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-2968-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Anti Torque Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Anti Torque devices due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Anti Torque. 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-2949-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 45mm Straight Rods

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 45mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 45mm Straight Rod. 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-2937-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

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

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. 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-3008-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Nut Inserters for Quality System Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Nut Inserters because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Nut Inserter B. 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-2917-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

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

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. 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-2873-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Instrument Taps for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 5.5 mm Instrument Taps because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 5.5 mm Instrument Tap. 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-2938-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

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

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. 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-2972-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Marking Pins for Quality Issues

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

    Product
    PALLAS M/MAXIMIS Marking Pin (Smooth). 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-2990-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Extension Sleeves for Quality System Issues

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

    Product
    PALLAS M/MAXIMIS Extension Sleeve. 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-2908-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality 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-2924-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS MIS Pedicle Screws because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2914-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical is recalling Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. 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-2923-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

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

    Product
    PALLAS M/MAXIMIS MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 x 45mm. 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide