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.

126–150 of 178

ModerateFDA (Devices)·Z-2906-2017·2017-08-16
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 7.5 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-2916-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System 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 6.5 x 50mm and 6.5 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 non-cervical
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2980-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Dilator B Spinal Fixation Components
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Dilator B components due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS Dilator 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-2931-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screw Spinal Fixation Devices
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because the devices are not consistent with 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-2987-2017·2017-08-16
Valorem Surgical Recalls Pallas M Extension Blocks for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Blocks because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Extension Block. 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-3006-2017·2017-08-16
Valorem Surgical Recalls Pallas M Tapper for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MISS/MIS Tapper 7.5 mm due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. 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-2995-2017·2017-08-16
Valorem Surgical Recalls Pallas M Rod Bender for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements. The devices are used for spinal fixation.
Product
PALLAS M/MAXIMIS Rod Bender. 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-2903-2017·2017-08-16
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 Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly 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-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
HighFDA (Devices)·Z-0784-2017·2016-12-28
Ultroid Procedure Pack Recalled for Quality System Non-Compliance
Ultroid Technologies is recalling 52,084 procedure packs because they were not manufactured under required quality system controls.
Product
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-0785-2017·2016-12-28
Ultroid Sterile Disposable Probes Recalled for Quality System Non-Compliance
Ultroid Technologies is recalling 7,784 sterile disposable probes because they were not manufactured under required quality system controls.
Product
Ultroid Sterile Disposable Probes sold individually
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-1881-2014·2014-07-02
Anspach eMax2 Foot Pedal Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 21 eMax2 Lower Profile Foot Pedals because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1879-2014·2014-07-02
Anspach Custom MCA5-1SD Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 20 Anspach Custom MCA5-1SD devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1895-2014·2014-07-02
Anspach Custom eMax 2 Plus Motor Recalled for Quality System Defects
The Anspach Effort, Inc. is recalling nine Custom eMax 2 Plus Motors because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1910-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1917-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1883-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1916-2014·2014-07-02
Anspach Arthroscopic Suture Anchor Threaders Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices, specifically arthroscopic suture anchor threaders, because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1903-2014·2014-07-02
Anspach Custom Device Autolube III Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Device Autolube III units because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1875-2014·2014-07-02
Anspach Knotless Suture Anchor Deployment Tool Recalled for Quality Issues
The Anspach Effort, Inc. is recalling Knotless Suture Anchor Deployment Tools because the units and records were not consistent with Quality System requirements.
Product
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1878-2014·2014-07-02
Anspach 8 mm Coarse Threaded Headless Bone Screw Recalled for Quality Issues
The Anspach Effort, Inc. is recalling 10 units of 8 mm Coarse Threaded Headless Bone Screws because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1897-2014·2014-07-02
Anspach Custom Pneumatic Motor Recall for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 45 Anspach Custom XMax Pneumatic Motors because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1886-2014·2014-07-02
Anspach Modified QD11 Attachment Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling six Modified QD11 Attachments because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1905-2014·2014-07-02
Anspach 13 mm Drill with Depth Stop Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 13 mm Drills with Depth Stops because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1877-2014·2014-07-02
Anspach 8 mm Coarse Headless Screw Recall for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 8 mm Coarse Headless Screws because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states