Hazard

Regulatory Non Compliance recalls

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

What the numbers show

Total: 536
Critical: 0
Severe: 56
Most recent: 2026-07-01

Of the 536 regulatory 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 56 (10%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all regulatory 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.

376–400 of 536

ModerateFDA (Devices)·Z-1541-2015·2015-05-06
Therasage Portable FAR Infrared Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling 8 portable FAR infrared saunas because they were distributed without FDA 510(k) approval.
Product
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1527-2015·2015-05-06
MedComp Recalls 9F Plastic Dual Port Vascular Access Devices
Medical Components, Inc. is recalling 325 units of 9F Plastic Dual Port vascular access devices because they were not covered under FDA clearance.
Product
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intrave
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1537-2015·2015-05-06
GA Industries Recalls Logicon Caries Detector for Lack of FDA Approval
GA Industries is recalling the Logicon Caries Detector software because it was released without FDA approval.
Product
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and dire
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1374-2015·2015-04-08
Biologic Therapies Recalls Bio-CORE Cannula Sets for Misbranding
Biologic Therapies, Inc. is recalling Bio-CORE Cannula (Needle) Sets because they were distributed without proper FDA clearance and classification.
Product
Bio-CORE Cannula (Needle) Set
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1372-2015·2015-04-08
Biologic Therapies Recalls Bio-PLASTY Cannulas for Misbranding
Biologic Therapies, Inc. is recalling 58 Bio-PLASTY Cannulas because they were distributed without proper FDA clearance and classification.
Product
Bio-PLASTY Cannula (Needle)
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1111-2015·2015-02-18
Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
Arthrosurface, Inc. is recalling 143 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.
Product
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1112-2015·2015-02-18
Arthrosurface Shoulder Prosthesis Components Recalled for Uncleared Marketing Status
Arthrosurface, Inc. is recalling 138 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.
Product
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1113-2015·2015-02-18
Arthrosurface Recalls Uncleared Taper Post Fixation Components
Arthrosurface, Inc. is recalling 182 units of Athrosurface Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.
Product
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1110-2015·2015-02-18
Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
Arthrosurface, Inc. is recalling 136 units of HemiCAP shoulder prosthetic components because they were not cleared for marketing in the US with current indications.
Product
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1114-2015·2015-02-18
Arthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance
Arthrosurface, Inc. is recalling 187 units of the HHXL (OVO) 15.6x32mm Taper Post Fixation Component because the product was not cleared for marketing in the US with its current indications.
Product
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0536-2015·2014-12-17
Instrumed Recalls External Vein Strippers Due to Regulatory Non-Compliance
Instrumed International is withdrawing 479 external vein strippers because the company did not market them before 1976, failing to meet FDA pre-amendment requirements.
Product
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Me
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0532-2015·2014-12-17
Instrumed Recalls Uterine Tenaculum Hooks for Regulatory Compliance
Instrumed International is withdrawing 26 uterine tenaculum hooks because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0543-2015·2014-12-17
Instrumed Recalls Cushing Burr Instruments for Regulatory Non-Compliance
Instrumed International is withdrawing Cushing burrs because the company failed to meet FDA requirements for marketing pre-amendment devices.
Product
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0555-2015·2014-12-17
Gardner-Wells wrenches withdrawn for pre-amendment regulatory non-compliance
Instrumed International is withdrawing Gardner-Wells wrenches because they were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0551-2015·2014-12-17
Instrumed Recalls Non-Springloaded Traction Tongs for Regulatory Compliance
Instrumed International is withdrawing 67 replacement screw non-springloaded traction tongs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.
Product
Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical bran
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0558-2015·2014-12-17
Instrumed Recalls 23 Schiotz Tonometers for Regulatory Non-Compliance
Instrumed International is withdrawing 23 Schiotz tonometers because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0544-2015·2014-12-17
Instrumed Recalls Hudson Burrs for Pre-Amendment Regulatory Non-Compliance
Instrumed International is withdrawing 16 Hudson burrs from the market because the company did not market these devices prior to September 26, 1976, and therefore does not meet FDA requirements for Pre-Amendment devices.
Product
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0556-2015·2014-12-17
Instrumed Recalls CVB Distraction Screws Due to Regulatory Non-Compliance
Instrumed International is withdrawing 790 CVB distraction screws because the devices were not marketed before 1976, failing FDA pre-amendment requirements.
Product
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Telef
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0542-2015·2014-12-17
Instrumed Recalls Cushing Perforating Drills for Regulatory Non-Compliance
Instrumed International is withdrawing nine Cushing perforating drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0533-2015·2014-12-17
Instrumed Recalls Endometrial Suction Curettes Due to Regulatory Non-Compliance
Instrumed International is withdrawing 26 endometrial suction curettes because the devices were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include cathet
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0548-2015·2014-12-17
Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance
Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing pre-amendment devices.
Product
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0547-2015·2014-12-17
Instrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
Instrumed International is withdrawing McKenzie enlarging burrs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.
Product
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0534-2015·2014-12-17
Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance
Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.
Product
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0550-2015·2014-12-17
Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance
Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss I
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0546-2015·2014-12-17
Instrumed Recalls D'errico Perforator Drills Due to Regulatory Non-Compliance
Instrumed International is withdrawing D'errico perforator drills because they do not meet FDA requirements for pre-amendment devices.
Product
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.
Category
Medical Device
Distribution
Distributed nationwide