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.

126–150 of 166

ModerateFDA (Devices)·Z-0558-2022·2022-02-09
Celltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed
Celltrion USA Inc. is recalling 162,000 units of the European version of its DiaTrust COVID-19 Ag Rapid Test, which was not approved for U.S. distribution. The test packaging and labeling differ from the FDA-approved U.S. version.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0456-2022·2022-01-12
Hemodialysis Delivery System distributed without FDA premarket approval
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.
Product
DBB-06 Hemodialysis Delivery System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2022·2021-11-10
COVENA PICC Sleeve Recalled for Unauthorized FDA Marketing
Queen Comfort Products is recalling the COVENA PICC Sleeve, marketed without FDA clearance. Patients currently using the device should contact their healthcare provider immediately.
Product
COVENA PICC Sleeve
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2021·2021-08-11
Home Artificial Insemination Kit Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.
Product
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2183-2021·2021-08-11
Artificial insemination kits recalled for lack of FDA authorization
Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.
Product
2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2180-2021·2021-08-11
TenderNeeds IUI Fertility Kits Distributed Without FDA Marketing Authorization
TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.
Product
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2179-2021·2021-08-11
Sterile Home Artificial Insemination Kits Recalled for Missing FDA Marketing Authorization
Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.
Product
2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2068-2021·2021-07-21
Arrow Pacing Catheter Kit Recalled for Missing FDA Premarket Clearance
Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.
Product
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1920-2021·2021-06-30
Medical Probe Cover Recalled Due to Missing FDA Premarket Clearance
Exact Medical Manufacturing recalls 78,000 probe covers that lacked FDA premarket clearance. The product was distributed for use in body openings without required 510(k) approval.
Product
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1909-2021·2021-06-30
Elastic Poly Probe Cover lacks required FDA 510k clearance
Exact Medical Manufacturing is recalling 17,545 units of a 6" x 48" Elastic Poly Probe Cover that lacks FDA 510(k) clearance for use in body openings. The product should not be used without proper FDA pre-market approval.
Product
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0930-2021·2021-02-03
B. Braun Introcan IV Safety Catheters Recalled for Lack of FDA Approval
Braxton Medical Corporation is recalling B. Braun Introcan IV Safety Catheters because the products do not have FDA approval for sale in the United States.
Product
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2713-2020·2020-08-05
TTDEYE Radial Pink Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Radial Pink colored contact lenses because they were distributed without FDA clearance.
Product
TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2708-2020·2020-08-05
TTDEYE Black Starshine Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Black Starshine colored contact lenses because they were distributed without FDA clearance.
Product
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2710-2020·2020-08-05
TTDEYE Flower Brown Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Flower Brown colored contact lenses because they were distributed without FDA clearance.
Product
TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2714-2020·2020-08-05
TTDEYE Devil Red Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd. is recalling TTDEYE Devil Red colored contact lenses because they were distributed without FDA clearance.
Product
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2709-2020·2020-08-05
TTDEYE Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Diamonds Starlight colored contact lenses because they were distributed without FDA clearance.
Product
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0354-2020·2019-11-20
Monarch Medical Technologies Recalls EndoTool SubQ Software Versions
Monarch Medical Technologies is recalling EndoTool SubQ software versions 1.7.1, 1.7.4, and 1.7.5 because the product was distributed prior to FDA approval or clearance.
Product
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0819-2018·2018-03-07
Accord Media Recalls Ultra Renew Devices for Unapproved LED Light
Accord Media, LLC is recalling 524 Ultra Renew devices distributed nationwide because they use an unapproved green LED light to treat hyperpigmentation.
Product
Ultra Renew
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0820-2018·2018-03-07
Accord Media Recalls Truth Renew Device for Unapproved LED Light
Accord Media, LLC is recalling 30 units of the Truth Renew device because it uses an unapproved green LED light to treat hyperpigmentation.
Product
Truth Renew
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0822-2018·2018-03-07
Accord Media Recalls Truth Renew Plus LED Light Device
Accord Media is recalling 67 units of the Truth Renew Plus device because it uses an unapproved green LED light to treat hyperpigmentation.
Product
Truth Renew Plus
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0821-2018·2018-03-07
Accord Media Recalls Ultra Renew Plus LED Light Device
Accord Media, LLC is recalling 1,040 units of the Ultra Renew Plus medical device because it uses an unapproved green LED light to treat hyperpigmentation.
Product
Ultra Renew Plus
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0621-2018·2018-02-21
Aesculap ELAN 4 Burr and Blade Accessories Recalled for Regulatory Violation
Aesculap Implant Systems LLC is recalling ELAN 4 burr and blade accessories because they were marketed without 510(k) premarket notification clearance.
Product
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0205-2018·2017-12-13
FDA Recalls Unapproved Compressible Limb Therapy Systems Due to Incorrect Air Compression
Won Industry Co. is recalling three unapproved Compressible Limb Therapy Systems because they have incorrect air compression level setups. The devices were distributed in Maryland, Texas, and Mexico.
Product
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure pro
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0204-2018·2017-12-13
FDA Recalls Two Unapproved Morning Life Air Compression Devices
Won Industry Co. is recalling two Morning Life air compression devices because they were distributed without FDA approval and have incorrect air compression settings.
Product
Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2376-2015·2015-08-19
Biotronik Recalls Unapproved Pacemaker Programmer Software Versions
Biotronik is recalling specific pacemaker programmer software versions because they are not approved for use in the United States.
Product
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
Category
Medical Device
Distribution
Distributed nationwide