Hazard

Unapproved Device recalls

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

What the numbers show

Total: 166
Critical: 0
Severe: 4
Most recent: 2026-06-10

Of the 166 unapproved device recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (2%) 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 unapproved device 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.

151–166 of 166

ModerateFDA (Devices)·Z-1540-2015·2015-05-06
Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling FAR-Infrared Heat Home Saunas because they were distributed without FDA 510(k) approval.
Product
FAR-Infrared Heat Home Sauna, 3 person 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
HighFDA (Devices)·Z-1335-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0951-2015·2015-01-21
FDA Recalls Unapproved Color Contact Lenses Contaminated with Bacteria
Intertrade Imports Inc. is recalling I Color Complete contact lenses because FDA testing found bacteria and the product is not sterile.
Product
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Targe
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0950-2015·2015-01-21
FDA Recalls Unapproved Color Contact Lenses Contaminated with Bacteria
Intertrade Imports Inc. is recalling I Color Complete color contact lenses because FDA testing found Bacillus Cereus and Bacillus Lentus. The lenses are also unapproved medical devices.
Product
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens Product Usage - Eye contact lens
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2625-2014·2014-09-17
Life Force Chamber Recalled for Lack of FDA Approval
Life Force of Tampa, LLC is recalling 10 Life Force Chambers because the product is marketed as a medical device without FDA premarket approval.
Product
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2040-2014·2014-07-16
Codan Recalls ColorSafe IV Lines Manufactured Before FDA Approval
Codan US Corporation is recalling ColorSafe IV lines because they were manufactured and marketed prior to FDA approval.
Product
ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809), CS400-G
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1576-2014·2014-05-21
FDA Recalls Unapproved Enaly 1000 BT-12 Ozone Generator for Medical Use
William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator because the device is not approved or cleared by the FDA for medical use.
Product
Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1352-2014·2014-04-16
LumiQuick Malaria Pan Antigen Test Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling Malaria pan Antigen Tests because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.
Product
Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1366-2014·2014-04-16
LumiQuick Recalls Tramadol Strips Shipped Without FDA Clearance
LumiQuick Diagnostics Inc. is recalling all lots of Tramadol Strips (Catalog 74003) because they were shipped to US locations without approved FDA applications or clearance.
Product
Tramadol Strip; LumiQuick. Santa Clara, CA 95054
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1362-2014·2014-04-16
LumiQuick PSA Test Card Recalled for Lack of FDA Clearance
LumiQuick Diagnostics Inc. is recalling PSA Test Cards (Whole Blood) because they were shipped to US locations without approved FDA applications or clearance.
Product
PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1809-2013·2013-07-31
FDA Recalls Unapproved Advanced Orthogonal Percussion Adjusting Instruments
The FDA is recalling 54 Advanced Orthogonal Percussion Adjusting Instruments because they are unapproved medical devices. The recall covers units distributed nationwide to chiropractors.
Product
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1143-2013·2013-04-24
Elana Catheter Sizer 2.0 Recalled for Unapproved Distribution
Elana, Inc. is recalling three Elana Catheter Sizer 2.0 devices because they were distributed in interstate commerce without FDA approval.
Product
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0875-2013·2013-03-06
KY TINGLING JELLY Personal Lubricant Recalled for Lack of FDA Clearance
McNeil-PPC Inc. is recalling KY TINGLING JELLY Personal Lubricant because the product is not cleared for marketing in the US.
Product
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0517-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved Baby Quasar Infrared LED Lamps
Quasar Bio-Tech is recalling Baby Quasar and Baby Quasar Pink infrared LED lamps because the devices are unapproved by the FDA.
Product
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest qual
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0518-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved Infrared LED Lamps and Accessories
Quasar Bio-Tech is recalling the Quasar MD and other infrared LED devices because they are unapproved for marketing in the United States.
Product
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0519-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved LED Skin Treatment Devices
Quasar Bio-Tech is recalling specific LED skin treatment devices because they are unapproved by the FDA.
Product
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWER
Category
Medical Device
Distribution
Distributed nationwide