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-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
  • 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
  • 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-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 s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-2985-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screw Extensions for Quality Issues

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Open Extensions because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Open Extension (Large). 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-2896-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 120mm MIS Rods for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 120mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 120mm MIS 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-2978-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Dilator Handles for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Dilator Handles because they are not consistent with Quality System Requirements. The devices are part of a spinal fixation system.

    Product
    PALLAS M/MAXIMIS Dilator Handle. 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-2902-2017·2017-08-16

    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-2963-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Tapper for Quality System Non-Compliance

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS Tapper 6.5 devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Tapper 6.5. 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-2957-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 40mm 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-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-2958-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 350 Straight Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 350 Straight Rods because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 350 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-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-2915-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical 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 45mm and 6.5 x 4.5 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 sp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2955-2017·2017-08-16

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

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

    Product
    PALLAS M/MAXIMIS 35mm 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-2909-2017·2017-08-16

    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 FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. 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-2967-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Holder for Quality System Non-Compliance

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

    Product
    PALLAS M/MAXIMIS Rod Holder. 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-2982-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 5.5mm Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Tapper 5.5mm because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Tapper 5.5mm. 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-2944-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 60mm Spinal Fixation Rods

    Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS 60mm curved and precontoured rods due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 60mm Curved and Precontoured 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-2962-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Tapper Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Tapper 5.5 spinal fixation devices due to quality system non-compliance.

    Product
    PALLAS M/MAXIMIS Tapper 5.5. 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-2874-2017·2017-08-16

    Valorem Surgical Recalls Pallas M 50mm Curved Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm Curved Rods because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 50mm 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-2922-2017·2017-08-16

    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 7.5 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-2964-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Wall Check Spinal Fixation Devices

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS Wall Check devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Wall Check. 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-2983-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 6.5mm Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS MIS Tapper 6.5mm devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Tapper 6.5mm. 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