Hazard

Unapproved Device recalls

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

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.

126–135 of 135

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-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-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-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
5 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
5 states